Summary Judgment
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NEW YORK
————————————————————————X
ANNIE TUMMINO, et al.,
Plaintiffs,
CV-05-0366 (ERK/VVP)
v.
ANDREW C. VON ESCHENBACH, in his official capacity as
commissioner of the Food and Drug Administration,
Defendant.
————————————————————————X
MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFF’S MOTION
FOR SUMMARY JUDGMENT
i
TABLE OF CONTENTS
INTRODUCTION………………………………………………………………………………………1
HISTORY OF THE PROCEEDINGS……………………………………………………………2
STATUTORY AND REGULATORY SCHEME……………………………………………7
STATEMENT OF FACTS ………………………………………………………………………….8
I. Scientific Information About Plan B………………………………………………………….8
II. Plaintiffs and Their Injury……………………………………………………………………..12
III. The History of the FDA’s Proceedings Regarding Plan B………………………..17
A. The Filing of the Citizen Petition and OTC Switch Application………17
B. Phase 1 OTC Switch Application: The FDA’s May 2004
Not Approvable Letter……………………………………………………………….20
1. Advisory Committee Review…………………………………………….20
2. Reaction in the Commissioner’s Office………………………………21
3. Review by the Professional Staff……………………………………….23
4. Issuance of the Not Approvable Letter……………………………….27
C. Phase 2 Switch Application: The Dual Status Application………………28
1. The Commissioner Pre-empts Approval of the
Revised OTC Switch Application………………………………………28
2. Continuing Scientific Review of the Barr Revised
OTC Switch Application…………………………………………………..29
3. The FDA Refuses to Act…………………………………………………..34
4. Public Acknowledgment of the Denial of the Citizen
Petition and the Adoption of the BTC Regime…………………….36
IV. The Government Accountability Office Investigation …………………………….39
V. The FDA’s Consideration of the Citizen Petition Was Heavily
Intertwined With Its Consideration of the Barr OTC Switch SNDA…………..40
ii
VI. The FDA’s Treatment of the Plan B OTC Switch Radically
Departs from the Manner In Which It Has Handled OTC Applications
Concerning Other Drugs………………………………………………………………………41
VII. The BTC Regime Reinforces Outmoded Stereotypes of Women……………..44
APPLICABLE LEGAL STANDARD…………………………………………………………46
ARGUMENT……………………………………………………………………………………………47
I. Plaintiffs Have Standing to Challenge the FDA’s Rejection of
Unrestricted OTC Status for Plan B. ………………………………………………………47
A. Plaintiffs Have Standing in Their Own Right………………………………..48
B. Plaintiffs Have Third-Party Standing to Assert the Rights
of Women Who Need Plan B……………………………………………………………50
II. The District Court Has Jurisdiction over Plaintiffs’ Claims and the
Court of Appeals Lacks Such Jurisdiction………………………………………………51
A. Plaintiffs Cannot Assert the Rights of Barr and Thereby Invoke
the Jurisdiction of the Court of Appeals……………………………………….60
B. Plaintiff and Citizen Petitioner Association of Reproductive
Health Professionals (ARHP) Is Not an “Applicant” under
Section 355 and Therefore Cannot Invoke the Jurisdiction of
the Court of Appeals………………………………………………………………….57
III. Plaintiffs Are Entitled to Summary Judgment on Their Four
Constitutional Claims…………………………………………………………………………..60
A. The BTC Regime Violates the Right to Decisional Privacy…………….62
B. The BTC Regime Violates Equal Protection of the Law…………………66
1. The BTC Regime Discriminates Based on Sex
Without Serving an “Exceedingly Persuasive
Justification.”…………………………………………………………………66
2. The BTC Regime Discriminates Based on the Exercise
of the Fundamental Right to Use Contraception…………………..70
C. The BTC Regime Violates Adult Women’s Right to
Informational Privacy………………………………………………………………..72
iii
IV. The FDA’s Denial of Unrestricted OTC Status for Plan B
is Arbitrary and Capricious……………………………………………………….74
A. This Court’s Repeated Findings of that the FDA Engaged in
“Improper Behavior or Bad Faith” In Its Plan B Review
Mandate a Finding that the FDA’s Actions are Per Se Arbitrary
and Capricious…………………………………………………………………………78
B. The FDA Relied on Factors Congress Did Not Intend It to Consider.82
1. The FDA Impermissibly Considered Personal Behavior……….83
2. The FDA Impermissibly Considered the Political
Acceptability of the Plan B OTC Switch Application…………84
C. The FDA’s Numerous Departures From Its Own Policies For
Deciding OTC Switch Applications Render the Rejection of OTC
Status for Plan B Arbitrary and Capricious…………………………………..86
D. The FDA’s Justification for Denial of Unrestricted OTC Status for
Plan B Runs Counter to the Evidence Before It and Is So Implausible
That It Cannot Be Ascribed to a Difference in View or the Product
of Agency Expertise…………………………………………………………………..90
1. Galson’s Speculation About Impact on the Sexual and
Contraceptive Behavior of Adolescents is Refuted by the
Available Evidence………………………………………………………….92
2. Galson’s Statements About Adolescent Impulsivity Have
No Link to Safe and Appropriate Use of Plan B as an OTC
Product and Are Refuted by the Scientific Evidence…………….96
A. “Inadequate Data on Adolescents”…………………………99
B. Label Comprehension Studies………………………………101
C. Actual Use Studies……………………………………………..104
D. Other Studies……………………………………………………..105
3. The BTC Regime’s Age Cutoff Has No Scientific
Justification…………………………………………………………………..108
V. The FDA’s Rejection of Unrestricted OTC Status for Plan B and Its
Promulgation of the BTC Regime Exceed the FDA’s Statutory Mandate….110
CONCLUSION……………………………………………………………………………………….113
iv
TABLE OF AUTHORITIES
Cases
Am. Pharm. Assoc. v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974)……………………………..110,111
Am. Postal Workers Union v. Frank, 968 F.2d 1373 (1st Cir. 1992)……………………………………..50
Amgen Inc. v. Smith, 357 F.3d 103 (D.C. Cir. 2004)……………………………………………………………47
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986)…………………………………………………………46
Atchison, Topeka, & Santa Fe R. v. Wichita Bd. of Trade, 412 U.S. 800 (1973)………………..75-76
Barnes v. Shalala, 865 F. Supp. 550 (W.D. Wis. 1994)……………………………………………………….55
Barr Labs., Inc. v. Harris, 482 F. Supp. 1183 (D.D.C. 1980)……………………………………………….57
Barr Labs., Inc. v. Thompson, 238 F. Supp. 2d 236 (D.D.C. 2002)……………………………………….57
Barry v. City of New York, 712 F.2d 1554 (1983)……………………………………………………………….73
Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003)…………………………………………………………………..49
Bloch v. Ribar, 156 F.3d 673 (6th Cir.1998)………………………………………………………………………73
Bowen v. Am. Hosp. Ass’n, 476 U.S. 610 (1986)………………………………………………………………..75
Bracco Diagnostics v. Shalala, 963 F .Supp. 20 (D.C.D.C. 1997)…………………………………………76
Bradley v. Weinberger, 483 F.2d 410 (1st Cir.1973)………………………………………………………53-54
Burlington N. & Santa Fe Ry. Co. v. Surface Transp. Bd., 403 F.3d 771
(D.C. Cir. 2005)……………………………………………………………………………………………………………..76
Carey v. Population Servs., Int’l., 431 U.S. 678 (1977)………………………………………………..passim
Clarke v. Sec. Indus. Ass’n, 479 U.S. 388 (1987)………………………………………………………………..47
Craig v. Boren, 429 U.S. 190 (1976)……………………………………………………………………………48, 50
Cutler v. Hayes, 818 F.2d 879 (D.C. Cir. 1987)………………………………………………………………….52
D’Amico v. City of New York, 132 F.3d 145 (2d Cir. 1998)………………………………………………….47
Doe v. City of New York, 15 F.3d 264 (2d Cir. 1994)……………………………………………………..73, 74
Eastwood v. Dept. of Corr., 846 F.2d 627 (10th Cir.1988)…………………………………………………..73
v
Eisenstadt v. Baird, 405 U.S. 438 (1972)………………………………………………………………..48, 40, 62
El Rio Santa Cruz Neighborhood Health Ctr. v. Dep’t of Health & Human Servs.,
300 F. Supp. 2d 32 (D.C. Cir. 2004)………………………………………………………………………………….76
Erickson v. Bartell Drug Co., 141 F.Supp.2d 1266 (W.D. Wash. 2001)………………………………..67
F.D.A. v. Brown & Williamson Tobacco, 529 U.S. 120 (2000)……………………………………………80
Genentech, Inc. v. Bowen, 676 F. Supp. 301 (D.D.C. 1987)…………………………………………………54
GlobalNet Financial.Com, Inc. v. Frank Crystal & Co., Inc., 449 F.3d 377 (2d Cir. 2006)……..47
Goldberg v. Whitman, 743 F. Supp. 943 (D. Conn. 1990)……………………………………………………69
Griswold v. Connecticut, 381 U.S. 479 (1965)……………………………………………………………………62
Haitian Ctrs. Council, Inc. v. Sale, 823 F. Supp. 1028 (E.D.N.Y. 1993)……………………….110, 111
Henley v. FDA, 873 F. Supp. 776 (E.D.N.Y. 1995)……………………………………………………….58, 60
Hodgson v. Minnesota, 497 U.S. 417 (1990)………………………………………………………………………65
In re Barr Labs., Inc., 930 F.2d 72 (D.C. Cir. 1991)……………………………………………………………57
In re Labady, 326 F. Supp. 924 (S.D.N.Y. 1971)………………………………………………………………..73
In re Sch. Bd. of Broward County, Fl., 475 F.2d 1117 (5th Cir. 1973)…………………………………..51
INS v. Yang, 519 U.S. 26 (1996)……………………………………………………………………………………….76
J.E.B. v. Alabama ex rel. T.B., 511 U.S. 127 (1994)……………………………………………………………69
Jean v. Nelson, 472 U.S. 846 (1985)…………………………………………………………………………………60
Kowalski v. Tesmer, 543 U.S. 125 (2004)…………………………………………………………………….56, 57
Latecoere Int’l, Inc. v. U.S. Dept. of Navy, 19 F.3d 1342 (11th Cir. 1994)……………………………..78
Lewis v. Thompson, 252 F.3d 564 (2d Cir. 2001)………………………………………………………………..56
Los Angeles v. Lyons, 461 U.S. 95 (1983)………………………………………………………………………….50
Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992)…………………………………………………………..47
Marsh v. Or. Natural Res. Council, 490 U.S. 360 (1989)…………………………………………………….74
Mass. Bd. of Retirement v. Murgia, 427 U.S. 307 (1976)…………………………………………………….70
vi
Morr-Fitz, Inc. v. Blagojevich, No. 4-05-1050, 2007 WL 900463 (Ill. App. Ct.
Mar. 19 2007)…………………………………………………………………………………………………………………14
Motor Vehicle Mfrs. Assoc. of the United States, Inc. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29, 43 (1983)……………………………………………………………………………………………….74, 75
NRDC v. Muszynski, 268 F.3d 91 (2d Cir. 2001)………………………………………………………………..75
Nat’l Nutritional Foods Ass’n v. Mathews, 557 F.2d 325 (2d Cir. 1977)……………………………….77
Noland v. U.S. Civil Serv. Comm’n, 544 F.2d 333 (8th Cir. 1976)………………………………………..51
Paradyne Corp. v. United States, 647 F. Supp 1228 (D.D.C. 1986)………………………………………75
Planned Parenthood v. Casey, 505 U.S. 833 (1992)……………………………………………………………69
Planned Parenthood v. Danforth, 428 U.S. 52 (1976)…………………………………………………………63
Planned Parenthood v. Planned Parenthood Ass’n of Utah v. Matheson, 582 F. Supp. 1001 (D.
Utah 1983)…………………………………………………………………………………………………………………….65
Porter v. Califano, 592 F.2d 770 (5th Cir. 1979)………………………………………………………………..61
Powers v. Ohio, 499 U.S. 400 (1991)………………………………………………………………………………..56
Ramos v. Town of Vernon, 353 F.3d 171 (2d Cir. 2003)………………………………………………………70
Rhodia, Inc. v. FDA, 608 F.2d 1376 (D.C. Cir. 1979)………………………………………………………….77
Roe v. Wade, 410 U.S. 113 (1973)……………………………………………………………………………….50, 62
Rubin v. Coors Brewing Co., 514 U.S. 476 (1995)………………………………………………………..64, 66
Rydeen v. Quigg, 748 F. Supp 900 (D.D.C. 1990)………………………………………………………………61
S.E.C. v. Chenery Corp., 332 U.S. 194 (1947)……………………………………………………………………78
Saks v. Franklin Covey Co., 316 F.3d 337 (2d Cir. 2003)…………………………………………………….67
Sandoz, Inc. v. Leavitt, 427 F. Supp. 2d 29 (D.D.C. 2006)…………………………………………………….3
Sec’y of State v. Joseph H. Munson Co., 467 U.S. 947 (1984)………………………………………………56
Singleton v. Wulff, 428 U.S. 106 (1976)…………………………………………………………………………….55
Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995)…………………………………………………….48
Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83 (1998)………………………………………………….55
Thorne v. City of El Segundo, 726 F.2d 459 (9th Cir.1983)………………………………………………….73
vii
Tourus Records, Inc., v. Drug Enforcement Admin., 259 F.3d 731 (D.C. Cir. 2001)……………….74
Transactive Corp. v. United States, 91 F.3d 232 (D.C. Cir. 1996)…………………………………………76
Tummino v. von Eschenbach, 427 F. Supp. 2d 212 (E.D.N.Y. 2006)…………………………………5, 79
United States v. Diebold, Inc., 369 U.S. 654(1962)……………………………………………………………..47
United States v. Virginia, 518 U.S. 515 (1996)……………………………………………………………..68, 70
United States v. Westinghouse Elec. Corp., 638 F.2d 570 (3d Cir.1980)………………………………..73
Village of Arlington Heights v. Metro Housing Dev. Corp., 429 U.S. 252 (1977)……………………69
Washington v. Davis, 426 U.S. 229 (1976)…………………………………………………………………………69
Webster v. Doe, 486 U.S. 592 (1988)………………………………………………………………………………..61
Whalen v. Roe, 429 U.S. 589 (1977)………………………………………………………………………………….73
Statutes & Rules
Fed. R. Civ. P. 56(c)……………………………………………………………………………………………………….46
21 C.F.R. § 10.30 (1994)…………………………………………………………………………………………………58
21 C.F.R. § 10.30 (a)(1994)……………………………………………………………………………………………..58
21 C.F.R. § 10.30 (b) (1994)…………………………………………………………………………………………….58
21 C.F.R. § 10.30(e)(2)(1994)……………………………………………………………………………………………8
21 C.F.R. § 310.200(b) (2005)………………………………………………………………………………………..7, 8
21 C.F.R. § 330.10(a)(4)(i)………………………………………………………………………………………………..7
21 C.F.R. § 330.10(a)(4)(ii)……………………………………………………………………………………………….7
21 C.F.R. § 330.10(a)(4)(v)……………………………………………………………………………………………….7
5 U.S.C. § 702………………………………………………………………………………………………………………..48
5 U.S.C. § 703………………………………………………………………………………………………………………..51
5 U.S.C. § 706(2)(A)………………………………………………………………………………………………….51, 74
viii
5 U.S.C. § 706(2)(B)……………………………………………………………………………………………………….51
5 U.S.C. § 706(2)(C)……………………………………………………………………………………………………….51
21 U.S.C. § 331………………………………………………………………………………………………………………49
21 U.S.C. § 333(a)…………………………………………………………………………………………………….12, 49
21 U.S.C. § 333(b)…………………………………………………………………………………………………….12, 49
21 U.S.C. § 352…………………………………………………………………………………………………………..7, 48
21 U.S.C. §§ 353(b)(1)………………………………………………………………………………………………12, 49
21 U.S.C. § 353(b)(1)(A)…………………………………………………………………………………………………..7
21 U.S.C. § 353(b)(3)………………………………………………………………………………………………….7, 53
21 U.S.C. § 355……………………………………………………………………………………………………….passim
21 U.S.C. § 355(b)…………………………………………………………………………………………………….52, 59
21 U.S.C. § 355(c)………………………………………………………………………………………………………3, 59
21 U.S.C. § 355(d)…………………………………………………………………………………………………….54, 55
21 U.S.C. § 355(h)……………………………………………………………………………………………….52, 55, 56
28 U.S.C. § 1331…………………………………………………………………………………………………………….51
Fla. Stat. § 465.015 (2004)…………………………………………………………………………………………12, 49
1
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NEW YORK
————————————————————————X
ANNIE TUMMINO, et al.,
Plaintiffs,
CV-05-0366 (ERK/VVP)
v.
ANDREW C. VON ESCHENBACH, in his official capacity as
commissioner of the Food and Drug Administration,
Defendant.
————————————————————————X
MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFF’S
FOR SUMMARY JUDGMENT
INTRODUCTION
Plaintiffs respectfully submit this memorandum of law in support of their motion for
summary judgment.1 Plaintiffs seek a judgment commanding the Defendant (hereinafter “the
FDA”) to switch the emergency contraceptive drug Plan B to unrestricted over-the-counter
status. Following years of resistance to removing Plan B from the category of drugs available
only with prescription, and over the nearly universal opposition of the agency’s professional
staff, the FDA has recently established a regime for marketing of Plan B that is unwarranted and
unprecedented in the agency’s history. Under the new regime, for the first time, a drug for which
no prescription is required is available only at pharmacies and health clinics. Moreover, only
1
In this Memorandum, documents supplied by the Government pre-stamped as “Tummino PAGE,” are so cited and
collected as Exhibit A. The Report of the Government Accountability Office on the FDA’s May 2004 rejection of
OTC status for Plan B is Exhibit B. Declarations submitted in support of Plaintiffs’ Motion for Summary Judgment
are Exhibits C-1 through C-6. Cited excerpts of deposition transcripts are contained in Exhibit D. Exhibit E
contains other cited documents. Exhibit F, to be filed under seal, contains cited documents and deposition excerpts
protected under a stipulation of the parties regarding confidential commercial information.
2
women (and men, for whom Plan B has no approved use) who are willing to present
government-issued identification proving that they are at least 18 years of age will be able to
obtain Plan B from pharmacies without a prescription. Other women, including all women under
18 and women who either do not have government-issued proof of age or are unwilling to
display it to pharmacy staff, must have a prescription in order to obtain Plan B. (We refer to this
regime below, which requires Plan B to be kept behind the pharmacy counter, as “the BTC
regime.”)
The FDA’s continuing invidious treatment of Plan B is not only arbitrary and capricious
within the meaning of the Administrative Procedure Act (“APA”) but also violates the
constitutional rights to privacy and equal protection of the law of women seeking Plan B as a
means of preventing pregnancy. In addition, the BTC regime exceeds the FDA’s statutory
mandate by impermissibly controlling the point of sale of a non-prescription drug and because it
is based on factors Congress did not intend the agency to consider in determining the
prescription status of drugs. Furthermore, Plaintiffs’ entitlement to summary judgment on each
of these claims is either conclusively demonstrated or considerably strengthened by the FDA’s
bad faith and improper actions throughout its consideration of Plan B’s prescription status, as
well as the Government’s bad faith actions in the course of this litigation. For the reasons set
forth below, the Court should grant Plaintiffs’ motion for summary judgment.
HISTORY OF THE PROCEEDINGS
The Government has consistently resisted all efforts to allow judicial scrutiny of the
FDA’s handling of the Plan B switch application. Plaintiffs filed this action on January 21,
2005, the date on which the FDA missed its statutory deadline for formal action on the then-
pending application of Barr Laboratories (hereinafter “Barr” or “the sponsor” or “the
3
manufacturer”) to switch Plan B to non-prescription status for women age 16 and over.2 At the
time, the FDA had also failed for four years to act on a Citizen Petition filed by one of the
Plaintiffs, which similarly sought a switch of all emergency contraception from prescription to
OTC status for all women. The Plaintiffs – individual activists who have transferred doses of
Plan B to women at protest events and non-profit organizations whose missions and work
include making Plan B accessible to women by educational outreach and information3 – sought
essentially the same relief they seek now: an injunction commanding the FDA to make Plan B
available as an OTC drug without age or other restrictions, i.e., in the same manner in which
FDA has made available numerous drugs with greater toxicity and more severe side effects than
Plan B.
The Government initially responded to the complaint on April 18, 2005, with a motion to
dismiss. After Plaintiffs served their response, the Government withdrew its motion and instead
sought a stay of proceedings. In its application for a stay, the Government represented to this
Court that there existed a plan that the FDA would take action on Barr’s application before
September 1, 2005, which the Commissioner had announced on July 13, 2005, to the United
States Senate, and that action would, in the Government’s words, “supplement and potentially
supersede the provisional determination embodied in the May 2004 letter.” (Def.’s July 25,
2005 Letter at 2.) Based on that representation, the Court granted the stay.
2
The Government has previously argued that the statutory deadline contained in 21 U.S.C. § 355(c) is not binding,
rather than mandatory, because subsequent Congressional action renders the deadline merely “aspirational.” Def.’s
Mot. for J. on the Pleadings at 33. A recent decision from the United States District Court for the District of
Columbia rejects exactly this argument, holding instead that the statutory deadline is mandatory. Sandoz, Inc. v.
Leavitt, 427 F. Supp. 2d 29 (D.D.C. 2006).
3
Plaintiffs now also include three young women under 18 and their parents, all of whom are directly injured by the
FDA’s BTC regime.
4
In fact, the only “action” the FDA took before September 1, 2005, was not action on the
application at all. Rather than issuing a decision, the FDA initiated a process to determine
whether a rulemaking process should begin. (Tummino 1922-23; Jenkins Dep. 290:14-291:9,
June 21, 2006). It invited public comment on whether the agency should engage in proposed
rulemaking that would determine whether the agency has the legal authority to mandate split
marketing not only of Plan B, but of any drug requiring FDA approval, and if so whether it
would be efficacious to do so.
Following the FDA’s non-action, the Court lifted the stay and ordered production of the
administrative record over the Government’s vehement objections. (See Aug. 2, 2004 Korman
Order at 1.) In response to the Court’s order, the Government produced voluminous materials
which it denominated the administrative record. In the so-called administrative record, the
Government included numerous documents disclosing the FDA’s deliberative process regarding
Plan B. Indeed, the Government stated that it had “made the decision not to raise the
deliberative process privilege with regard to documents in the administrative record to which that
privilege may apply.” (Nov. 8, 2005 Hr’g Tr. 15.) The Government erroneously represented
that the record contained all of the information relevant to the FDA’s deliberations. In fact, for
example, numerous substantive e-mail deliberations have been withheld to this date on
deliberative process grounds. (See, e.g., Privilege Log submitted by the FDA on March 29, 2007
(Doc. 233 Attachment 2).)
The Government then filed a motion for judgment on the pleadings, principally raising
procedural objections to the Court’s review of the agency’s actions. This Court denied the
motion on December 22, 2005, and at the same time authorized Plaintiffs to undertake limited
5
discovery beyond the administrative record as determined in the first instance by the Magistrate
Judge assigned to the case.
Plaintiffs accordingly sought to depose certain FDA current and former employees whom
the administrative record disclosed had played a role in the agency’s consideration of Plan B.
The Government resisted all of these efforts, essentially re-arguing to the Magistrate Judge the
same contentions it had urged upon this Court in its rejected motion to dismiss. The Magistrate
Judge similarly rejected the Government’s effort to block all discovery, finding that discovery
was authorized both because Plaintiffs had alleged an unreasonable delay claim and because
Plaintiffs had made a strong preliminary showing of bad faith and improper agency action. See
Tummino v. von Eschenbach, 427 F. Supp. 2d 212, 231-32 (E.D.N.Y. 2006). The Government
did not appeal that ruling to the Court, and it remains law of the case. Although the Magistrate
issued the discovery ruling on February 24, 2006, including in it authorization for depositions of
specific witnesses, the Government did not make a single witness available for deposition until
April 26, 2006, and it was not until December 11, 2006, that Plaintiffs were able to complete a
total of eleven depositions.
Faced with the prospect of judicial review of its non-action on the Citizen Petition, on
June 9, 2006, some five years after action on it was due, and 17 months after this action was
commenced, and after Plaintiffs had amended their complaint to allege an unreasonable delay
claim, the FDA admitted that it had denied the Citizen Petition. (Ltr. from Randall W. Lutter,
formally denying the Citizen Petition, dated June 9, 2006 (hereinafter “Cit. Pet. Denial Ltr.”),
attached to Def.’s Ltr. to Chief Judge Korman, dated June 28, 2006 (Doc. 160-2).) Although it
had never issued any public statement, the FDA averred that Plaintiffs should have recognized in
May of 2004 that the Citizen Petition was denied when the FDA issued a non-approvable letter
6
in response to Barr’s application. (Cit. Pet. Denial Ltr. at 7 n.9.) At a July 26, 2006, status
conference, this Court characterized the FDA’s letter announcing its denial of the Citizen
Petition as “reek[ing] of bad faith.” (See July 26, 2006 Hr’g Tr. 9.) At that same conference, the
Court suggested to the Government that there was no reason that the FDA could not approve
Plan B as a non-prescription drug for women 17 and older. The Government vigorously rejected
that possibility, contending that an age-restricted non-prescription regime could not be
implemented by the FDA without “well established . . . statutory and regulatory authority to
undertake such a split marketing approach.” (See July 26, 2006 Hr’g Tr. 21.) Despite the
Government’s protestations, within one month the FDA implemented an age-restricted non-
prescription regime similar to that which the Court had suggested, albeit with a higher age cutoff
than had ever previously been contemplated and with an unprecedented restriction on businesses
which could sell Plan B as a non-prescription drug.
Since the FDA’s implementation of the BTC regime, the Government has continued to
resist outstanding discovery. Notwithstanding its waiver of the deliberative process privilege
when it disclosed documents that depicted its version of the decision-making process, the
Government has repeatedly relied on that privilege to block access to numerous documents
which, on inspection, the Magistrate Judge found to contain evidence of the FDA’s bad faith.
The Government also has resisted all efforts by Plaintiffs to obtain evidence from the White
House regarding its involvement in the Plan B process. The Court has held resolution of these
outstanding discovery matters in abeyance pending submission of the parties’ cross-motions for
summary judgment, while recognizing that it may be necessary to revisit the issue if the Court
determines that the discovery will be needed to decide the dispositive motions.
7
STATUTORY AND REGULATORY SCHEME
By statute, the FDA is authorized to limit a drug to prescription status only when
“because of its toxicity or other potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, [it] is not safe for use except under the supervision of a
practitioner licensed by law to administer [it].” 21 U.S.C. § 353(b)(1)(A). As a result of this
statutory provision (“the Durham-Humphrey Amendment”), enacted in 1951, the FDA views
OTC status as the “default” status for drugs. See http://www.fda. gov/cder/Offices/OTC/FDA-
CHPA%20seminar%20Oct%202/tsld013.htm. A drug which has initially been assigned
prescription status “shall be exempted from prescription-dispensing requirements when the
Commissioner finds such requirements are not necessary for the protection of the public health
by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use,
or the collateral measures necessary to its use, and he finds that the drug is safe and effective for
use in self-medication as directed in proposed labeling.” 21 C.F.R. § 310.200(b) (2005); see also
21 U.S.C. § 353(b)(3) (2005) (“The Secretary may by regulation remove drugs subject to
sections 352(d) and 355 of this title from the requirements of paragraph (1) of this subsection
when such requirements are not necessary for the protection of the public health.”).
Under the FDA’s regulations, an approved drug is suitable for OTC use when: (1) the
drug is safe for self-medication, 21 C.F.R. § 310.200(b); 21 C.F.R. § 330.10(a)(4)(i); (2) the drug
is effective when self-administered, 21 C.F.R. § 310.200(b); 21 C.F.R. § 330.10(a)(4)(ii); (3) the
condition to be treated is self-diagnosable; and (4) the drug’s labeling is tailored to self-
administration, 21 C.F.R. § 310.200(b); 21 C.F.R. § 330.10(a)(4)(v). The FDA has developed its
own internal criteria for assessing OTC switch applications, known as the “Peck criteria” after
former CDER Director Carl Peck. These criteria are: 1.) Does the product have an acceptable
margin of safety based on prior prescription marketing experience; 2.) Does the product have
8
low misuse and abuse potential; 3.) Can the condition be adequately self-recognized and
successfully self-treated with minimal health care provider intervention; 4.) Do the benefits from
the switch to non-prescription status clearly outweigh the risks; and 5.) Is the self-treatment
product safe and effective during consumer use. (Tummino 10137-38; Jenkins Dep. 192:9-
193:17, Aug. 14, 2006.)
In addition, FDA regulations explicitly authorize the use of a citizen petition to seek a
switch from prescription to OTC status: “A proposal to exempt a drug from the prescription-
dispensing requirements of section 503(b)(1)(C) of the act may be initiated by . . . any interested
person . . . fil[ing] a petition . . . pursuant to Part 10 of this chapter . . . .” 21 C.F.R. § 310.200(b).
Within 180 days after a citizen petition has been filed, the FDA is required by its regulations to
either approve the petition, deny the petition, or “[p]rovide a tentative response, indicating why
the agency has been unable to reach a decision on the petition, e.g., because of the existence of
other agency priorities, or a need for additional information.” 21 C.F.R. § 10.30(e)(2).
STATEMENT OF FACTS
I. Scientific Information About Plan B.
Plan B is a progestin-only contraceptive that can be used to reduce the risk of pregnancy
after unprotected intercourse. (Jordan Decl. ¶ 3.) It acts to prevent fertilization and/or
implantation and does not interfere with an established pregnancy. It is the only emergency
contraceptive product that is on the market in the United States. Plan B has no known serious
side effects or serious long term health effects. Instead, it has mild and short-term side effects
such as nausea. When used as directed, Plan B can reduce the risk of unintended pregnancy by
9
up to 89%. The effectiveness of Plan B is greater the sooner after unprotected intercourse it is
used, and may be higher if taken within the first 24 hours. (Jordan Decl. ¶ 4).
The approved regimen for Plan B is two doses of levonorgestrel taken twelve hours apart.
(Tummino 11030.) Recent studies show that Plan B is equally effective if the two doses are
taken closer together than 12 hours apart or at the same time. (Jordan Decl. ¶ 3; Houn Dep.
122:11-123:2, July 20, 2006; Tummino 11031.) The approved instructions for using Plan B can
be comprehended adequately by all women of child-bearing age without the assistance of a
physician or other learned intermediary. (Tummino 31085.) Indeed, the instructions for its use
are far simpler than the instructions for the proper use of numerous other OTC drugs. (Tummino
31097; Jenkins Dep. 101:1-18.) The FDA’s Division of Pediatric Drug Development recognized
that the age breakdown in the studies submitted by Barr reflected the age breakdown of Plan B
consumers:
The relative distribution of adolescent data reflects the use of Plan B and EC in
adolescents, as well as the relative proportions of adolescents requesting Plan B.
According to Advance PCS (prescription use data found in Appendix C), the
youngest adolescents (8-14 years) accounted for <0.5% of total claims for either
Plan B or Preven during 2002-2004. Teenagers, age 15-17 years, represented 5%
of total claims. Use in children under age 12 was minimal, accounting for no
more than 8-12 of the over 10,000 prescriptions per year.
(Tummino 10941.) This usage profile is similar to the age breakdown in Barr’s Label
Comprehension and Actual Use studies, particularly for the younger age groups. In addition, the
age breakdown is similar to that in the other studies of Plan B reviewed by the FDA.
Although the FDA does not require the submission of Label Comprehension or Actual
Use studies in support of over-the-counter (OTC) switch applications (see Center for Drug
Evaluation and Research, Manual of Policies and Procedures 6532.1, Review Management,
Over-the-Counter (OTC) Labeling and Use Studies, available at
10
http://www.fda.gov/cder/mapp/6532.1.pdf), Barr submitted both types of studies. In addition to
Barr’s studies, the FDA’s professional staff reviewed dozens of other published and unpublished
studies that examined the safety and effectiveness of Plan B and which also examined whether
use of Plan B caused changes in participants’ sexual or contraceptive behavior. (Tummino
30745-83; 30784-828; 31095-99.) The professional staff also reviewed several studies which
examined whether women of child-bearing ages could use Plan B effectively without the
guidance of a learned intermediary. None of these studies revealed the existence of any
significant difference between women under 17 and those 17 and over (nor between women
under and over 18) in their changes in contraceptive behavior, sexual behavior, or ability to use
Plan B effectively.
The equivalent of Plan B is available as an OTC drug without age restriction in India, the
Netherlands, Norway, and Sweden. (Jordan Decl. ¶ 9.) No adverse health or behavioral effects
are known to have arisen in these countries as a result of OTC availability of the drug. (Id.) Plan
B is available without a physician’s prescription or age restriction in Alaska, California, Hawaii,
Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and Washington. (Jordan Decl.
¶ 8.) There are no known adverse health or behavioral effects in these states from this wider
availability of the OTC drug. (Id.) Plan B is also available without a physician’s prescription in
38 countries. (Jordan Decl. ¶ 11.) The United States is the only country on Earth that imposes a
different regime for the availability of Plan B for women under 18. (Jordan Decl. ¶ 11.)
Numerous medical and public health organizations, recognizing the importance of wide
and easy access to Plan B as a means to reduce the number of unintended pregnancies and
subsequent abortions, have supported unrestricted OTC access for Plan B. Each of the following
has endorsed OTC status for Plan B without age restriction: the American College of
11
Obstetricians and Gynecologists, a leading organization of medical specialists in the United
States in Obstetrics and Gynecology; the American Academy of Pediatrics, a leading
organization of medical specialists in the United States in Pediatrics; the American Public Health
Association, a leading organization of public health specialists in the United States; and the
American Medical Association (AMA), a leading organization of physicians in the United States.
(Grimes Decl. ¶ 9.)
The FDA’s own internal processes confirm that Plan B is safe for use as an OTC product
without age or point-of-sale restrictions. A Joint Advisory Committee composed of experts in
reproductive medicine and science and experts in OTC drugs that the FDA convened to consider
the OTC switch of Plan B overwhelmingly recommended approval of the switch without age
restriction. (Tummino 10792.) Both Office Directors who are assigned by FDA policies the
responsibility to approve or disapprove OTC switch applications recommended approval of the
Plan B OTC switch without age restriction. Numerous FDA Medical officers recommended
approval for the Plan B OTC switch without age restriction: John Jenkins (Dir. Offc. of New
Drugs), Sandra Kweder (Deputy Dir. Offc. of New Drugs), Jonca Bull (Dir. Offc. of Drug
Evaluation V), Florence Houn (Dir. Offc. of Drug Evaluation III), Julie Beitz (Deputy Dir. Offc.
of Drug Evaluation III), Charles Ganley (Dir. of Div. of OTC Drug Products), Donna Griebel
(Deputy Dir. Div. of Reproductive and Urologic Drug Products), Curtis Rosebraugh (Deputy
Dir. Div. of OTC Drugs), Daniel Davis (Medical Officer of Div. of Reproductive and Urologic
Drug Products), and Andrea Leonard-Segal (Medical Team Leader of Div. of OTC Drugs). In
contrast, no FDA employee has offered a coherent, much less legally relevant, scientific
explanation for the imposition of any age restriction or point-of-sale restriction on Plan B.
12
Rather, only vague and non-scientific explanations have been offered by FDA officials who
opposed unrestricted OTC status.
II. Plaintiffs and Their Injury.
Plaintiffs comprise individual activists who seek unrestricted OTC status for Plan B in
part because they want to be able to transfer Plan B to women of any age without fear of criminal
prosecution, and in part because their own constitutional rights are violated by the BTC regime;
individuals under the age of 18 and their parents, each of whom wants unrestricted OTC access
to Plan B; and two organizations whose mission of enhancing awareness about and access to
Plan B is thwarted by the BTC regime.
Plaintiffs Annie Tummino, Erin T. Mahoney, Carol Giardina, Kelly Mangan, Stephanie
Seguin, Lori Tinney, Jennifer Brown, Candace Churchill, and Francie Hunt are Coordinators of
the Morning After Pill Conspiracy. One or more of them has access to one or more doses of Plan
B, and each intends, plans, and has pledged to provide Plan B to friends or other women of any
age – including women under the age of 18 and women over 18 who lack government-issued
identification or who lack timely access to a pharmacy or health clinic – whom they learn need
Plan B to prevent pregnancy. None of these plaintiffs is licensed or authorized by law in any
state to prescribe or dispense drugs. Consequently, unless unrestricted OTC status for Plan B is
implemented, each of them risks violating federal and state criminal statutes if she carries
through on her plan to provide Plan B to women of all ages who need it to prevent pregnancy.
See, e.g., 21 U.S.C. §§ 353(b)(1), 333(a), 333(b) (2005); § 465.015, Fla. Stat. (2004). Each of
them also objects to the requirement contained in the BTC regime that she must disclose her
name, address and age to a pharmacist and/or pharmacy employee in order to obtain Plan B. In
13
addition, each objects to the disclosure of information to third parties about her personal sexual
activity that may occur because, in order to obtain Plan B without a prescription, she is required
to present identification to a pharmacist or pharmacy employee.
Some of the Plaintiffs have recently attempted to obtain Plan B under the BTC regime,
and their experiences confirm that the BTC regime imposes barriers to women’s access. For
example, Plaintiff Mahoney was not permitted to purchase more than one package of Plan B
from a pharmacy in New York. (Mahoney Decl. ¶ 7.) Plaintiff Brown was told by a pharmacist
in Gainesville, Florida, that she should not purchase multiple packages of Plan B for possible
transfer to friends because doing so would deprive pharmacists of the opportunity to discuss
these friends’ birth control practices with them; and the pharmacist inquired in front of other
customers about Brown’s own methods of contraception. (Brown Decl. ¶¶ 6-9.) In addition,
because she tried to purchase Plan B after 9 p.m., she had to visit two stores before she found a
third with a pharmacy that was open. (Brown Decl. ¶¶ 4-5.) When Plaintiff deMarco tried to
purchase Plan B and stated that she wanted it for her 13-year-old daughter’s possible future use,
she was told by the pharmacist she visited that she could not do so. (deMarco Decl. ¶ 12.) And
Plaintiff ARHP has received numerous reports of difficulties women have faced in trying to
obtain prescriptions for Plan B and in filling those prescriptions. (Jordan Decl. ¶ 19.) Obviously,
unrestricted over-the-counter status for Plan B would not subject consumers to any of these
intrusive inquiries or limitations. Plaintiffs’ experiences confirm that the BTC regime imposes
barriers and, because of its oddity among regimes with which pharmacists are familiar, actually
encourages pharmacist refusal to sell Plan B. Of course, even without the encouragement of the
BTC regime, some pharmacists already refuse to sell Plan B, even as a prescription drug. See,
14
e.g., Morr-Fitz, Inc. v. Blagojevich, No. 4-05-1050, 2007 WL 900463 (Ill. App. Ct. Mar. 19
2007; see also Tummino 31032.)
Plaintiffs Robert Jaffe and Aurora deMarco are the parents of a 13-year-old daughter,
Plaintiff Angelica Jaffe. Robert and Aurora want their daughter to be able to obtain Plan B
without a prescription and without any restriction on its point-of-sale in order to maximize the
likelihood that she will avoid unwanted pregnancy. (DeMarco Decl. ¶¶ 3-4.) Angelica herself
wants to be able to obtain Plan B without a prescription and without any restriction on its point
of sale so as to maximize the likelihood that she will avoid unwanted pregnancy. In addition,
Aurora believes that the BTC regime perpetuates outmoded and demeaning stereotypes of
women that undermine her efforts to teach her daughter Angelica that women are not inferior to
men. (DeMarco Decl. ¶¶ 8-10.) Plaintiff Catherine Lederer-Plaskett is the mother of a 16-year-
old daughter, Plaintiff Aliza Lederer-Plaskett.4 Both want Aliza to be able to obtain Plan B
without a prescription and without any restriction on its point of sale so as to maximize the
likelihood that she will avoid unwanted pregnancy. Plaintiff Jonathan Marks is the father of a
13-year-old daughter, Plaintiff Gabrielle Marks. They both want Gabrielle to be able to obtain
Plan B without a prescription and without any restriction on its point of sale so as to maximize
the likelihood that she will avoid unwanted pregnancy.
Plaintiff Association of Reproductive Health Professionals (ARHP) is a non-profit
membership association composed of experts in reproductive health. These professionals include
physicians, advanced practice clinicians (nurse practitioners, nurse midwives, physician
assistants), researchers, educators, pharmacists, and other professionals in reproductive health,
4
Aliza will turn 17 before this motion is fully briefed, and thus falls into the category of women (who all scientists
at FDA agreed could safely and appropriately use Plan B as an OTC drug, but are barred from doing so by the BTC
regime), which imposes an age cut-off of 18. See infra at 38.
15
some of whom have authority to prescribe drugs and some of whom do not. (Jordan Decl. ¶ 13.)
ARHP and its members provide reproductive health services and education, conduct
reproductive health research, and influence reproductive health policy. Specifically, ARHP
works to improve the reproductive health of women by reducing the number of unintended
pregnancies among women. (Jordan Decl. ¶ 14.) ARHP, along with Princeton University’s
Office of Population Research (OPR), manages the Emergency Contraception Hotline (1-888-
Not-2-Late) and Website (www.not-2-late.com), which aim to prevent unintended pregnancy by
providing women of all ages and their partners information about, and rapid access to,
emergency contraception. Both the Hotline and Website are highly utilized tools, currently
receiving an average of 66,600 calls and 1,180,000 unique website visits per year. These calls
and visits include calls and visits by women under the age of 18, women over 18 who lack
government issued identification, and women who lack timely access to a pharmacy or health
clinic. The Hotline is an automated, toll-free, 24-hour, confidential service available in both
English and Spanish that gives callers general emergency contraception information and a list of
the five emergency contraception providers nearest to them (including a list of pharmacists in
states where pharmacists are permitted by state law to dispense Plan B to those who require a
prescription). It is available from any phone in the United States, Puerto Rico, U.S. Virgin
Islands, British Columbia, and the Yukon Territory. The Website, available in English, French,
Spanish, and Arabic, is the most comprehensive emergency contraception clearinghouse in the
world available to anyone via the World Wide Web. It features frequently asked questions about
emergency contraception, a publications bibliography, a Plan B materials database, and a
searchable database of Plan B providers across the country, Puerto Rico, Guam, U.S. Virgin
Islands, and British Columbia. The full directory of providers can be searched by city, state, area
code, and zip code. The NOT-2-LATE database also lists pharmacists in Alaska, California,
16
Washington State, New Mexico, and British Columbia. ARHP and OPR work closely with local
pharmaceutical associations to sign up pharmacists who dispense Plan B behind the counter.
Vermont has recently become the ninth state—joining Alaska, California, Hawaii, Maine,
Massachusetts, New Hampshire, New Mexico, and Washington—to allow direct dispensation of
Plan B by pharmacists. FDA admitted on June 9, 2006, that it had denied ARHP’s petition to the
FDA to switch Plan B to OTC status for women of all ages. (Cit. Pet. Denial Ltr.) The BTC
regime and the denial of unrestricted OTC status interfere with ARHP’s ability to educate health
care providers and the public about emergency contraception, interfere with ARHP’s efforts to
reduce the number of unintended pregnancies and its efforts to use the Emergency Contraception
Hotline and Website to achieve that goal, and interfere with its members’ ability to accomplish
the goal of improving the reproductive health of women. (Jordan Decl. ¶¶ 17-19.) ARHP sues
on its own behalf, on behalf of its members who lack prescribing authority and their patients and
clients who seek Plan B who are under 18, are over 18 and lack government issued identification,
lack timely access to a pharmacy or health clinic, or are over 18 and object to showing
identification in order to obtain Plan B, and on behalf of the women who utilize the Hotline and
Website to obtain access to Plan B.
Plaintiff National Latina Institute for Reproductive Health (NLIRH), is a non-profit
organization formed under section 501(c)(3) of the Internal Revenue Code. NLIRH conducts a
Plan B education and outreach project which seeks to educate providers of Plan B and potential
users of Plan B about what Plan B is, how to use it, and how to obtain it and, for providers, how
to incorporate it into their practice. NLIRH’s Plan B education outreach projects are impeded by
the age-restricted behind-the-counter dual prescription/nonprescription status for Plan B. If Plan
B is switched to OTC status for women of all ages, NLIRH will be able to improve access to
17
Plan B by enhancing its Plan B educational programs for both the health care providers and the
public participants involved in those projects. NLIRH sues on its own behalf and on behalf of
the women participants in its Plan B projects who are of childbearing age, including women who
are under 18, are over 18 and lack government-issued identification, lack timely access to a
pharmacy or health clinic, or are over 18 and object to showing identification in order to obtain
Plan B.
Some or all of the Plaintiffs assert the constitutional interests of all women to make Plan
B as widely and easily accessible as possible. Each woman who is (1) under 18 years of age and
needs Plan B; (2) over 18 but lacks adequate proof of age to obtain Plan B without a prescription;
(3) over 18 but lacks timely access to a pharmacy or health clinic so as to maximize the
effectiveness of Plan B; or (4) must present identification including proof of age to a pharmacist
or health clinic and thereby disclose at least her name and possibly her address to third-parties to
obtain Plan B, is irreparably injured as a direct result of the BTC. All or some of the Plaintiffs
above want to and intend to try to make Plan B available to women in each of these categories,
and assert third-party standing to assert these women’s interests.
III. The History of the FDA’s Proceedings Regarding Plan B.
A. The Filing of the Citizen Petition and OTC Switch Application
On February 25, 1997, the FDA announced that certain combined oral contraceptives are
safe and effective for emergency contraception, and requested the submission of NDAs for that
use. (Tummino 30167.) That announcement led two manufacturers to obtain approval for
emergency contraceptive pills, Plan B (on July 28, 1999) and Preven. Preven has since been
withdrawn from the market. (GAO Rep. at 42.)
18
Recognizing that timely and wide access to emergency contraception pills would be
improved by eliminating the requirement of a prescription, on February 14, 2001, plaintiff
Association of Reproductive Health Professionals, together with the American Public Health
Association, the American Medical Women’s Association, the National Asian Women’s Health
Organization, the National Black Women’s Health Project, the National Family Planning and
Reproductive Health Association, and 60 other medical, public health, and other organizations
filed a Citizen Petition asking the FDA to grant OTC status to Plan B, Preven, and any new drug
eligible for filing an abbreviated new drug application because of its equivalence to Preven or
Plan B. The Citizen Petition asserted that emergency contraception is suitable for OTC status
because it: 1.) is safe for self medication; 2.) has a low risk of abuse or overdose and has no
contraindications that would pose a danger to the patient; 3.) can easily be self-administered; and
4.) would make emergency contraception more accessible to women because it would allow
them to obtain it in a timely fashion, thereby allowing women to prevent unwanted pregnancies
and promoting public health. (01P-0075 CP1.)
The Citizen Petition contained statements of support for OTC emergency contraception
from some of the organizations that submitted it, and was accompanied by a supporting
declaration of Drs. David Grimes and Elizabeth Raymond. Dr. Raymond conducted the Label-
Comprehension and Actual Use studies submitted by the manufacturer in support of the Plan B
switch application. Dr. Grimes chaired the World Health Organization’s Task Force on
Postovulatory Fertility Regulation, which conducted the largest and most definitive clinical trials
of Plan B to date. (Grimes Decl. ¶ 2.) Supplements to the Citizen Petition were filed on August
7, 2001 and February 13, 2002. The FDA did not announce that it had denied the Citizen
Petition until June 9, 2006.
19
Parallel to the Citizen Petition, Women’s Capital Corporation (WCC), then the
manufacturer of Plan B, began to consult with the FDA about submitting an OTC switch
application and what the FDA would expect such an application to contain. On April 18, 2002,
Dr. Daniel Shames, then-Acting Director of the Division of Reproductive and Urologic Drugs,
issued a letter to WCC stating that the FDA declined to issue a Written Request for a proposed
pediatric study (which, if WCC or Barr had conducted the requested pediatric study, would have
triggered an additional six months of exclusive marketing, and thus additional revenue from Plan
B for the manufacturer (see 21 U.S.C. § 355a(b)(2005)), on the grounds that the results of the
proposed adult population trials could be extrapolated to the postmenarchal pediatric
population, and that the current labeling regarding use of Plan B in the pediatric population was
adequate. (Tummino 30100.)
The Office of the Commissioner of the FDA injected itself into discussions about the
Plan B OTC switch application even before WCC filed the application. On June 5, 2002, in
anticipation that WCC would be submitting an application to make Plan B available OTC, a
briefing was held for the Office of the Commissioner. Among the discussion topics were the
“political sensitivity” of the application and the question of whether the NDA would be assigned
priority review status or standard review status upon submission. (Tummino 30167.) On July
10, 2002, Dr. Janet Woodcock, then Director of CDER, provided Dr. Crawford, then-Deputy
Commissioner, and Daniel Troy, FDA’s Chief Counsel, with materials on the safety of
emergency contraception and its mechanism of action, which were requested at the June 5, 2002
briefing. (Tummino 30219-30235.) The memo stated, inter alia, that accidental use of
emergency contraception has not been associated with adverse outcomes. (Tummino 30219-20.)
20
On April 22, 2003, WCC submitted its sNDA to the FDA to switch Plan B to OTC status.
(Tummino 31020.)
B. Phase 1 OTC Switch Application: The FDA’s May 2004 Not Approvable
Letter
1. Advisory Committee Review
On June 9, 2003, review staff within the Office of Drug Evaluation III accepted the Plan
B sNDA for review and set a Prescription Drug User Fee Act (PDUFA) goal date of February
20, 2004, to make a decision on the application. (GAO Rep. at 42.) On September 26, 2003,
WCC participated in a conference call with FDA staff from the Offices of Drug Evaluation III
and V, which included a discussion of the upcoming joint public meeting of FDA’s
Nonprescription Drugs Advisory Committee and Reproductive Health Drugs Advisory
Committee. WCC also announced that on September 23, 2003, its board voted to sell the entire
new drug application for Plan B to Barr Laboratories. (Tummino 30342-30345.)
On December 16, 2003, at a joint meeting of the Nonprescription Drugs Advisory
Committee and Reproductive Health Drugs Advisory Committee, Advisory Committee members
reviewed and made recommendations on how the FDA should respond to the application for
OTC status for Plan B. They voted 23-4 in favor of the recommendation that Plan B be switched
from prescription to OTC status. (Tummino 10792.) Advisory Committee members voted
unanimously that Plan B is safe for use in a non-prescription setting. They voted 27-1 that the
Actual Use Study data submitted by Barr were generalizable to the overall population of
potential non-prescription users of Plan B. (Tummino 10754.)
These lopsided favorable votes occurred despite the fact that the Reproductive Health
Drugs Advisory Committee was itself appointed in an unusual manner. (Houn Dep. 30:7-44:9;
Kweder Dep. 28:10-14, Dec. 11, 2006; Griebel Dep. 14:14-21, 18:20-19, July 19, 2006). The
21
Office of the Commissioner of the FDA rejected the nominees proposed by CDER, claiming that
the nominees lacked a “balance of opinion,” a term for which CDER staff was unable to obtain
further clarification. (Kweder Dep. 30:4-21, 28:16-29:3.) Instead, the Commissioner’s office
appointed several members of the Committee whom, according to Sandra Kweder, CDER’s
Deputy Director of the Office of New Drugs, CDER staff viewed as “not people [CDER] would
normally have considered as the kind of people we would be looking for to be on the”
Committee, because they had “very limited experience in product development, clinical trials.
They were not well-published. They were not people who had the kind of stature in the
community that we were seeking.” (Kweder Dep. 35:3-12; see also Houn Dep. 38-8-12.)
(“[T]he contention was over the constitution of the panel, the type of experts needed, and the
lack of expertise in some of the nominees relevant to the function of the Reproductive Health
Drugs Advisory Committee.”). Kweder concluded that the Commissioner’s office sought
balance of ideological opinion (Kweder Dep. 36:12-21) because “[the appointees from the
Commissioner’s Office] were – these were people who were very active in the Right to Life
antiabortion world, again with [one exception].” (Kweder Dep. 37:8-10.) According to Dr.
Kweder, during her tenure as Deputy Director of Office of New Drugs, except around the time of
the formation of this Committee, nominations have not come from Office of the Commissioner
“before or really since.” (Kweder Dep. 37:16-20.)
2. Reaction in the Commissioner’s Office
Before even the date on which the FDA records having received the Plan B sNDA as
being submitted, then Commissioner Dr. Mark McClellan on April 21, 2003 discussed the
pending Plan B OTC switch application with White House domestic policy official Jay
22
Lefkowitz. (Tummino 509.) Contacts between McClellan and the White House about Plan B
occurred periodically thereafter.5 (McClellan Dep. 140:19-141:13, June 13, 2006.)
In late December of 2003 or early January of 2004, before scientific reviews of the OTC
switch application had been completed, Acting Deputy Commissioner Woodcock, Acting CDER
Director Galson, Director of the Office of New Drugs Jenkins, and Deputy Director of the Office
of New Drugs Kweder met for lunch at a restaurant near the FDA’s office in Rockville,
Maryland. (Jenkins Dep. 17:16-18:2; 19:2-10; Kweder Dep. 44:16-20.) At that lunch, Galson
and Woodcock informed Jenkins and Kweder that Commissioner McClellan had decided that the
Barr OTC switch application would be rejected by the FDA. (Jenkins Dep. 17:6-11; 18:2-17;
20:7-10; Kweder Dep. 44:3-45:8, 46:2-8.) They were also told that this decision was made in
collaboration with the White House. (Kweder Dep. 56:8-57:5.) Neither Galson nor Woodcock
appeared satisfied with this decision by the Commissioner. (Jenkins Dep. 20:7-10; Kweder Dep.
48:16-49:5.) But Galson later expressed his concern that if he did not go along with the
Commissioner’s decision, his position at the FDA would be jeopardized. (Jenkins Dep. 51:7-8,
232:12-20; Wood Dep. 24:9-22, July 31, 2006.)
On January 15, 2004, Dr. Galson, then-Acting Director of CDER, informed members of
the Offices of Drug Evaluation III and V and the Office of New Drugs that the Office of the
Commissioner recommended a non-approval letter based on the need for more data to “more
5
Because the Court has stayed proposed documentary discovery on the White House, Plaintiffs have been unable to
test the veracity of McClellan’s assertion that the purpose of this contact was to keep the White House updated about
the Plan B process in order to respond to media inquiries and to inform the White House that the FDA was
conducting scientific reviews. We note that McClellan was exceedingly unforthcoming in his 11-line non-response
to the Government Accountability Office’s detailed written questions (McClellan Dep. Ex. 1 at MBM01-03
(attached hereto at Ex. E)), and generally evasive during his deposition. Mr. McClellan also failed to respond to a
letter dated November 17, 2005, from United States Senator Carl Levin, then-ranking minority member of the
Permanent Sub-Committee on Investigations of the Committee on Homeland Security and Governmental Affairs,
regarding Plan B. (McClellan Dep. 35:4-36:22, Ex. 1 at MBM11-12 (attached hereto at Ex. E).)
23
clearly establish appropriate use in younger women and/or the need to develop a restricted
distribution plan” to address use in younger women. Representatives from Offices of Drug
Evaluation III and V informed Dr. Galson that reviews of the Plan B OTC switch application
were not yet complete and that there was additional data on the use of Plan B in adolescent girls.
(Tummino 30666-70.) Scientific review staff later noted in their completed reviews that they
were told at this meeting that the decision on the application would be made at a level higher
than the Offices of Drug Evaluation, the normal locus of that decision under the CDER’s policy
manual. (GAO Rep. at 17.)
Within days after the January 15 meeting, Dr. Woodcock telephoned Dr. Houn, director
of the Office of Drug Evaluation III which oversees reproductive health drugs. Dr. Houn had
been upset after the January 15 meeting, and Dr. Jenkins had suggested to Dr. Woodcock that
she speak with Dr. Houn. During a telephone conversation, Dr. Woodcock informed Dr. Houn
that the Plan B process was unfolding as it was in order to appease the constituents of President
Bush. (Houn Dep. 59:12-60:6; see also Jenkins Dep. 270:13-18 (confirming that he asked
Woodcock to contact Houn).)
3. Review by the Professional Staff
Pursuant to FDA regulations, the FDA’s professional staff continued with their review of
the merits of Barr’s OTC switch application. On January 9, 2004, Dr. Curtis Rosebraugh,
Deputy Director of the Division of OTC Drugs, issued a review of Barr’s Supplemental NDA
(Tummino 30443-56), in which he recommended that the application be approved, concluding
that “Plan B has an acceptable safety profile, low misuse and abuse potential and reasonable
therapeutic index of safety…[W]hen used under non-prescription conditions the product is safe
and effective.” (Tummino 30454.) He went on to note that Plan B has the potential to decrease
24
unwanted teen pregnancies by 70% and would also likely result in a decrease in teen abortions.
Based on these numbers, he stated that the “potential benefit of this for teen physical and mental
health far outweigh the minor risks associate with Plan B use. (Tummino 30455.)
On January 21, 2004, Dr. Jonca Bull, Director of Office of Drug Evaluation V (which
oversees nonprescription drugs), issued a memorandum stating that she was in agreement with an
“overwhelmingly favorable assessment” of the Plan B OTC switch application by the FDA
review staff and the majority votes by the Joint Advisory Committee. (Tummino 30651.) Dr.
Bull reported that the sponsor “adequately demonstrated that women of reproductive potential
across relevant age subgroups can use the product appropriately” and that “there is a compelling
rationale that OTC availability is imperative to better ensure proper use of the product.”
(Tummino 30651.) She further noted that “the agency’s regulatory mandate is not to regulate
behavior or morality but to serve the public by ensuring that safe and effective products are made
available for prescriber and patient choice.” (Tummino 30650.)
On January 23, 2004, FDA staff from the Office of New Drugs and the Offices of Drug
Evaluation III and IV met with representatives from Barr Laboratories and WCC. At that
meeting, FDA officials informed Barr that while the Divisions were prepared to negotiate
labeling, they had been told on January 15, 2004, that the decision on the Plan B OTC switch
application would be made by CDER upper level management. They further informed Barr that
a decision by upper level management “is not the usual or typical CDER process for determining
the approvability of an NDA,” and that the Divisions were in the process of completing their
reviews of the application and would forward the reviews along with their final
recommendations on the application to CDER upper management. (Tummino 30686-90.) FDA
staff also conveyed to the sponsor that the Office of the Commissioner and the Acting Director
25
of CDER raised concerns about whether there was adequate data to establish that minors will use
Plan B appropriately in the absence of a learned intermediary, even though reviews of the Plan B
switch application had not yet been completed. (Tummino 30687.)
Despite this decision by the Commissioner, scientific review staff, all of whom were
convinced that Plan B should be switched to OTC status without restriction, forged ahead with
their scientific reviews in order to preserve a complete record of their scientific judgment.
(Jenkins Dep. 27:17-30:2.) On February 18, 2004, review staff from the Offices of Drug
Evaluation III and V presented additional data and analysis to Commissioner McClellan on the
acceptability of the Plan B OTC switch application after reviewing numerous studies on
adolescents. (Tummino 30719-44.) After reviewing the sponsor’s Actual Use Study as well as
additional data from four studies on the use of emergency contraception submitted after the
December 2003 Advisory Committee meeting, with particular attention paid to use in
adolescents, the Divisions concluded that “the benefits of timely access outweighed any risk for
all women, including adolescents” and supported OTC availability without any age restriction.
(Tummino 30720.)
Commissioner McClellan, who was not present for the entire meeting (Houn Dep. 49:20-
50:7), stated that he was “not convinced” the studies had enough “power” to determine if there
were behavioral differences between adults and adolescents. (Tummino 30721.) The
Commissioner directed CDER to work with the sponsor on a marketing plan to limit OTC
availability of Plan B and to consider the most appropriate age groups to be restricted from
access to the product. Id.
On February 19, 2004, review staff in the Office of New Drugs and the Offices of Drug
Evaluation III and V met with Dr. Janet Woodcock and Dr. Steven Galson. During the meeting
26
Dr. Woodcock re-iterated the Commissioner’s and her concerns about adolescent use of Plan B.
Dr. Woodcock expressed particular concern that OTC status of Plan B could lead to “extreme
promiscuous behaviors” and that the medication could take on “‘urban legend’ status that would
lead adolescents to form sex based cults centered around the use of Plan B.” (Tummino 30745-
46.) Dr. Galson stated that he shared those concerns. (Id.)
On March 24, 2004, Dr. Rosebraugh issued an addendum to his prior review
memorandum, which was joined by Dr. Jonca Bull. In this memo, Dr. Rosebraugh reasserted his
conclusion that Plan B meets the criteria for OTC marketing without restriction. He emphasized
that adolescents would “derive great benefit” from OTC access to Plan B and that “[a]ny system
that creates barriers to access, including restricted distribution or age restrictions, would defeat
the purpose of this drug and lessen its public health potential. (Tummino 30757.) He also noted
that Plan B was being held to a higher regulatory standard than other drugs, and suggested that “a
natural progression” of the line of reasoning applied to Plan B regarding behavior concerns
would result in the removal of OTC status for such drugs as laxatives (because of abuse by
bulimics) and Tylenol (because of its use in suicide attempts). (Tummino 30757-58.) He
concluded: “In terms of OTC switch applications, this drug has more information available to
allow us to predict consumer behavior than any drug in recent memory. If this is not enough data
upon which to base a decision, it is unclear what would constitute enough data or even if that is
an obtainable goal. (Tummino 30757.)
On April 1, 2004, Dr. Donna Griebel, Deputy Director of the Division of Reproductive
and Urologic Drugs, issued a lengthy review of the Plan B OTC switch application
recommending approval for switch of Plan B to non-prescription status. (Tummino 30829-80.)
Dr. Griebel found that the risk-benefit ratio of non-prescription access to Plan B supports its
27
approval for over-the-counter status. She also concluded that “it is unjustified to restrict access
to the benefit of this product on the basis of age.” (Tummino 30877.) On April 2, 2004, Dr.
Julie Beitz, Deputy Director of the Office of Drug Evaluation III, recommended that Plan B be
approved for OTC status with no age restriction based on her completed review of the Plan B
OTC switch application. She found that there was sufficient data on the safety and effectiveness
of Plan B to approve its use in an OTC setting with no restriction. (Tummino 30881-91.)
On April 22, 2004, Dr. John Jenkins, the Director of the Office of New Drugs, issued his
review of the Plan B application. (Tummino 30897-900.) He concurred in the recommendations
of the Offices of Drug Evaluation III and V that the sponsor provided adequate data
demonstrating that Plan B can be used safely, effectively, and appropriately by women of
childbearing potential. (Tummino 30898.) Dr. Jenkins recommended that Plan B be made
available over-the-counter without any age restriction. (Tummino 30897-900.)
4. Issuance of the Not Approvable Letter
Despite the unanimous view of all the scientific reviewers, on May 5, 2004, Dr. Galson
informed members of the Offices of Drug Evaluation III and V and the Office of New Drugs –
consistent with his statements at the late December/early January lunch and the January 15
meeting — that the action letter on the Plan B OTC switch application would be a Not
Approvable letter, and that the reason for the Not Approvable action was a lack of data in the
under-16 age group. Dr. Galson asserted that non-medical or political views about the drug and
sexual behavior did not factor into the decision. Dr. Galson further stated that the FDA staff’s
disagreement with the Not Approvable action would be acknowledged publicly. (Tummino
30912-14.)
28
Dr. Galson’s internal memorandum justified this action in part on the view that
adolescents have diminished capacity (compared with adults) to make rational decisions, a view
for which he obtained cursory support in an e-mail exchange three days earlier. (Tummino
30908-11.) Accordingly, on May 6, 2004, FDA issued a Not Approvable letter on the Plan B
OTC switch application based on a lack of adequate data regarding safe use by younger
adolescents. The letter stated that the application cannot be approved until the sponsor either
provides data demonstrating that Plan B can be used safely by women under age 16 without
professional supervision, or provides additional information in support of a dual marketing plan
that would sell Plan B as a prescription-only product for women under age 16 and as a
nonprescription product for women age 16 and older. (Tummino 30904-07.)
C. Phase 2 Switch Application: The Dual Status Application
On July 21, 2004, Barr Laboratories submitted a revised OTC switch application that
asked that Plan B be made available to women age 16 and older without a prescription while
requiring women age 15 and younger to obtain a prescription for Plan B. (Tummino 30921.)
Again, the FDA professional staff undertook to review the appropriateness of the application in
light of the scientific evidence and the agency’s statutory charge.
1. The Commissioner Pre-empts Approval of the Revised OTC Switch
Application
On November 12, 2004, Dr. Hari Cheryl Sachs of the Division of Pediatric Drug
Development at the FDA issued a review of the Plan B OTC switch application stating that the
sponsor’s submission fulfills the requirements of the Pediatric Research Equity Act of 2003
(PREA) for post-menarchal females. Dr. Sachs concluded that the sponsor submitted sufficient
data to assess the efficacy of Plan B for its intended use, and that the sponsor sufficiently
29
demonstrated the safety of Plan B for use in adolescents. (Tummino 10939-10949.) Dr. Sachs
observed, inter alia, that the age breakdown in the sponsor’s actual use study was similar to the
age breakdown of prescription users of Plan B. (Tummino 10941.) On November 16, 2004, Dr.
Lisa Mathis, Acting Division Director of the Division of Pediatric Drug Development concurred
with Dr. Hari Cheryl Sachs’ conclusion that the PREA requirements for adolescents over age 14
were met. (Tummino 10949.)
All the FDA scientific reviews of the Plan B switch application other than Dr. Galson’s
recommended that the Barr application be rejected in favor of unrestricted OTC approval.
Despite this unanimous view, which was based upon a review of scientific literature about Plan
B that went far beyond the studies conducted by the manufacturer, in January of 2005, Dr.
Steven Galson asked Dr. John Jenkins to draft an approvable letter for the Plan B OTC switch
application approving Plan B for over-the-counter status for women age 17 and over. (Jenkins
Dep. 145:18-147:15.) Before Galson could issue such a letter, however, Acting Commissioner
Lester Crawford removed Dr. Galson’s authority to make a decision on the Plan B application.
(Crawford Dep. 46:1-49:20, 140:12-146:3, May 24, 2006; Galson Dep. 186:15-187:18, 205:1,
206:20, April 26, 2006.)
2. Continuing Scientific Review of the Barr Revised OTC Switch
Application
Despite the removal of Galson’s authority to issue a decision on the amended Plan B
switch application, the scientific staff undertook reviews of the amended application and
uniformly rejected the age restriction urged by upper management. On January 12, 2005, Dr.
Daniel Davis, a Medical Officer in the Division of Reproductive and Urologic Drugs, issued a
Review of Complete Response to the Not Approvable action on the Plan B OTC switch
application. Dr. Davis concluded that “[t]here are no new safety findings that would preclude
30
the approval of changing Plan B from prescription status to over-the-counter status.” (Tummino
31020.) He noted that the data submitted by the sponsor during the original review cycle showed
that Plan B is “safe and efficacious when used in accordance with proposed labeling” and that it
could be distributed over-the-counter without any age or distribution restrictions, and without the
need for any additional clinical studies. (Tummino 31020.) Dr. Davis found that the sponsor’s
request that Plan B remain prescription-only for adolescents under age 16 was not “warranted or
desirable.” (Tummino 31020.)
On January 12, 2005, Dr. Curtis Rosebraugh, Deputy Director of the Division of Over-
the-Counter Drug Products, issued a Division Director Memo-Addendum in response to the
sponsor’s amended application seeking over-the-counter approval for Plan B for consumers age
16 and over, which was also signed by Dr. Jonca Bull, Director of the Office of Drug Evaluation
V, and Dr. Charles Ganley, Director of the Division of Over-the-Counter Drug Products.
(Tummino 31026-30.) Dr. Rosebraugh concluded that: 1.) the Plan B application met the
Durham-Humphrey Amendment criteria for over-the-counter marketing without restriction; 2.)
any systems that created barriers to access to Plan B “would defeat the purpose of the drug and
lessen its public health potential”; and 3.) implementation of an age restriction “for theoretical
abuse by a small segment of the population” would have ramifications for how the FDA
regulates other OTC drugs where known abuse by the population and by adolescents exists, such
as dextromethorphan, laxatives, and analgesics. (Tummino 31026.) In his Memo Addendum
regarding the amended Plan B OTC switch application, Dr. Rosebraugh stated that he has “many
concerns regarding the regulatory precedent” that approval of a dual marketing plan based on age
would set and the possible unintended consequences of such plan. He stated that he was
“concerned that the regulatory precedent that would be set by requiring adolescents to obtain a
31
prescription to access an otherwise OTC contraceptive product may have implications for other
OTC contraceptive products that are currently marketed which do not bear age restrictions and
have not submitted adolescent data for OTC marketing. In the past when the Division [of Over-
the-Counter Drug Products] has felt that there was insufficient data to warrant labeling for a
particular age group, [the Division has] labeled the product with language that reflects that under
a certain age, a physician should be consulted, but an age restriction for sale of the product was
not part of the labeling.” (Tummino at 31027.) Notably, Dr. Rosebraugh also concluded that, “It
is unclear what additional data could be provided on adolescent use that would be sufficient to
lift the age restriction in the future.” (Tummino at 31027.)
On January 12, 2005, Dr. Donna Griebel, Deputy Director of the Division of
Reproductive and Urologic Drugs, issued a Memorandum in response to Barr’s amended Plan B
OTC switch application affirming her April 1, 2004, Review of the Plan B OTC switch
application and recommending full over-the-counter status for Plan B with no age restriction.
Consequently, she did not recommend the amended Plan B switch application requesting dual
status based on age for approval. (Tummino 31031-31084.) Dr. Griebel stated that she did not
support the sponsor’s split label application for two reasons: 1.) Labeling the product to require a
prescription for consumers under age 16 sets a precedent that “could have negative consequences
on current products sold as non-prescription products, including contraceptive products like
condoms and spermicidal products.”; and 2.) Creating an age restriction for over-the-counter sale
of Plan B “could have the unintended public health consequence of limiting access to women of
all ages.” (Tummino at 31031-32.) Dr. Griebel expressed concern that enforcing an age
restriction for a reproductive health drug could be viewed as an undesirable legal burden for
pharmacies that may prompt pharmacies to cease carrying Plan B altogether. She further noted
32
that “there are multiple reported instances in the media and in the medical literature of
pharmacists who refuse to fill prescriptions for the current prescription product because they
believe it causes medical abortion.” (Tummino at 31032.)
On January 12, 2005, Dr. Julie Beitz, Deputy Director of the Office of Drug Evaluation
III, issued a memorandum concurring with the Division of Reproductive and Urologic Drug
Product’s recommendation to approve Plan B for over-the-counter status with no age restriction.
(Tummino 31085-87.) Dr. Beitz concluded that there is sufficient data illustrating the safety and
effectiveness of Plan B to approve its use in an over-the-counter setting without any age
restriction, and expressed concern about the sponsor’s proposal to retain prescription status for
Plan B for adolescents under age 16 based on “the regulatory precedent that would be set by
requiring adolescents to obtain a prescription to access an otherwise OTC contraceptive
product.” (Tummino 31086.) She was concerned about the implications of such a precedent on
other OTC contraceptive products that are not currently restricted by age. Dr. Beitz also noted
the existence of products that are currently available to adolescents over-the-counter that, if
misused, carry many more safety risks than would occur due to misuse of Plan B. (Tummino
31086.) She further noted the difficulty of enforcing an age restriction on Plan B in a retail
pharmacy setting. (Tummino 31086.) Finally, like Dr. Rosebraugh, Dr. Beitz stated that “it is
unclear what additional data Barr could provide on adolescent use of Plan B that would be
sufficient to lift the age restriction in the future.” (Tummino 31086.)
On January 14, 2005, Dr. John Jenkins, Director of the Office of New Drugs, issued a
memorandum stating that he supported full over-the-counter access of Plan B with no age
restriction, and that the sponsor’s dual marketing plan should not be approved. (Tummino
31095-99.) Dr. Jenkins believed that the dual marketing plan should be rejected because there is
33
“no scientific basis for the differentiation in prescription and non-prescription status based on
age and such an approach is inconsistent with well established FDA precedent with regard to
labeling OTC products for use in adult and pediatric populations.” (Tummino at 31096.) In
response to Dr. Galson’s previously stated concerns about the relatively small number of subjects
under the age of 16 in the Label Comprehension and Actual Use studies, Dr. Jenkins stated that,
“It is entirely reasonable to extrapolate the findings from the older women in these trials to
adolescents given well established agency precedent for extrapolating data from studies in adults
and older adolescents to younger adolescents and the fact that there was no suggestion based on
the data from the sponsor’s studies that younger women were less able to use the product
correctly in a simulated OTC setting than older women.” (Tummino 31096-97.) Dr. Jenkins
noted that a decision to approve Plan B for both prescription and over-the-counter status for the
same indication with the only difference being the patient’s age “sets an important policy
precedent that must be carefully considered and justified. In my opinion, such an approval for
Plan B cannot be justified based on scientific data . . . and such an approval has the potential to
raise other serious scientific and policy issues.” (Tummino 31097.)
Dr. Jenkins additionally noted that concerns previously raised by Dr. Galson about the
developmental differences between adolescents and older women “are more applicable to the
ability of adolescents to make reasoned decisions about engaging in sexual intercourse, not their
ability to understand how to use Plan B safely and effectively as an emergency contraceptive
should they engage in unprotected sexual intercourse.” (Tummino at 31097.) Dr. Jenkins
concluded his memorandum in support of OTC status for Plan B without an age restriction with
the following observation:
Products that are indicated for uses related to sexual activity in adolescents raise concerns
for some people that go beyond a finding based on clinical trial data that the product is
safe and effective for its intended use in adolescents. These concerns are derived from
34
individual views and attitudes about the morality of adolescent sexual behavior and also
overlap with concerns about the role for parents and health care professionals in decisions
about contraceptive use in adolescents. While acknowledging these concerns, I believe
that the available data clearly support a conclusion that Plan B meets the statutory and
regulatory requirements for availability without a prescription for all age groups. Such a
conclusion is consistent with how the Agency has made determinations for other OTC
products, including other forms of contraception available without a prescription.
(Tummino 31098.)
3. The FDA Refuses to Act
On January 21, 2005, all of the professional staff remained unanimous that the age
restrictions in Barr’s revised OTC switch application should be rejected and that Plan B should
be available over-the-counter to women of all ages. But apparently because Acting
Commissioner Crawford removed Dr. Galson’s authority to approve age-restricted OTC status
for Plan B that Galson had instructed Dr. Jenkins to draft, the FDA missed the PDUFA deadline
to issue a decision on the Plan B switch application. No further scientific reviews were
conducted between January 14, 2005 (the date of the Jenkins Phase 2 memo) and Dr. Crawford’s
announcement of advanced notice of proposed rulemaking in August of 2005. Nobody at the
FDA, including Deputy Commissioner Woodcock, knew what process Crawford was
undertaking during this period. (Woodcock Dep. 68:20-22, April 26, 2006; Galson Dep. 202:4-
9.)
The FDA’s inaction moved members of the Senate to place a hold on the confirmation of
Acting Commissioner Crawford. To remove the hold, Michael Leavitt, the Secretary of Health
and Human Services on July 13, 2005, sent a letter to Senator Michael Enzi, Chairman of the
Senate Committee on Health, Education, Labor and Pensions, assuring him that action would be
taken on the Plan B application by September 1, 2005 (a letter that was used by the Government
to obtain a stay of proceedings from this Court). (See Def’s Ltr. Mot. to Chief Judge Korman,
dated July 25, 2005 at 2 (Doc. 20).) On July 18, 2005, Crawford was confirmed by the Senate to
35
be FDA Commissioner. See 151 CONG. REC. S8438 (daily ed. July 18, 2005). Despite Secretary
Leavitt’s assurance, and despite a memorandum dated August 26, 2005 from Dr Galson stating
that the sponsor’s proposal to switch Plan B to OTC status meets the statutory standards for
approval for women age 17 and older, (Tummino 31214-26), on August 26, 2005, the FDA
announced that it was not going to make a decision on the Plan B OTC switch application by
September 1, 2005, and instead announced that it would implement a 60-day public comment
period on the enforceability of a dual marketing program. The FDA did not specify when a
decision on the Plan B OTC switch application would be made. See FDA website at
http://www.fda.gov/bbs/topics/news/2005/NEW01223.html (August 26, 2005 Crawford press
release) (last checked on March 29, 2007).
The FDA’s announcement moved Dr. Susan Wood, Director of the Office of Women’s
Health, to resign from her post on August 31, 2005 over the agency’s handling of the Plan B
OTC switch application. (Wood Dep. 13:17-14:17; see also Wood Dep. Ex. 2, July 31, 2006)
(Deposition Exhibit is attached hereto at Ex. E). When Dr. Wood met with Dr. Woodcock to
discuss her resignation, Dr. Woodcock discussed her own concern that the FDA’s handling of
Plan B could damage Woodcock’s credibility if the FDA continued to delay action. (Wood Dep.
40:2-19.) On October 7, 2005, Dr. Frank Davidoff, a member of the FDA’s Nonprescription
Drug Advisory Committee resigned due to the FDA’s delayed action on the Plan B OTC switch
application. (Tummino 7509-10; Jenkins Dep. 258:20-260:11 (stating that he does not ever
recall an Advisory Committee member resigning in protest prior to Dr. Davidoff)).
Dr. Crawford resigned as Commissioner of the FDA on September 23, 2005. Dr.
Andrew von Eschenbach was named Acting Commissioner. On November 1, 2005, the 60-day
public comment period on the enforceability of a dual marketing program for Plan B expired.
36
(Tummino 10820.) Review of the comments was outsourced to a private company, ICF
International, which completed its final review of the comments on May 19, 2006. (Tummino
10816.) In the meantime, the FDA remained utterly silent.
4. Public Acknowledgment of the Denial of the Citizen Petition and the
Adoption of the BTC Regime.
While the FDA continued its administrative stall, Plaintiffs continued their efforts to
conduct appropriate discovery of the FDA’s decision making process in this litigation. On June
9, 2006, while claiming that it had not rejected the Barr “dual status” application, the FDA
acknowledged its denial of the Citizen Petition, stating that the petition failed to submit adequate
data to satisfy the statutory requirements needed to approve Plan B for OTC status, and that the
petitioners are not a party to the sNDA proceedings and may not therefore require the agency to
render a decision on Barr’s sNDA based on the information submitted by Barr to the FDA. (Cit.
Pet. Denial Ltr. at 15-19.) This acknowledgment of the denial of the Citizen Petition came in the
midst of Plaintiffs’ discovery which began to reveal the degree to which the Office of the
Commissioner of the FDA had steered the Plan B process for non-scientific reasons and as
Plaintiffs began to compile evidence that high-level FDA officials sought to cover-up the non-
scientific bases for the FDA’s actions. In addition, it came weeks after Plaintiffs announced their
intention to seek discovery of White House documents describing the White House’s role in the
FDA’s handling of Plan B. (May 31, 2006 Hr’g Tr.) The Government quickly exploited the
denial letter to once again purpose a halt to discovery. (See Def.’s Ltr. to Chief Judge Korman,
dated June 28, 2006 (Doc. 160) at 4.)
On July 31, 2006, Acting Commissioner von Eschenbach, whose confirmation by the
Senate was still outstanding, abandoned his predecessor’s exploration of rulemaking as a means
to resolve alleged regulatory issues raised by Barr’s amended Plan B OTC switch application and
37
informed Barr that the FDA was proceeding with further evaluation of the Plan B application.
(Tummino 10864.)
In the third phase of the review process, FDA scientific reviewers again rejected the
propriety of an age restriction. Dr. Beitz, Acting Director of the Office of Drug Evaluation III,
reiterated her view that no age restriction was appropriate “[i]n the absence of new data to
support” such a restriction. (Tummino 10927.) Dr. Ganley, Director of the FDA’s Office of
Nonprescription Products, likewise stated “[n]o new data was provided to suggest the restriction
based on age is necessary.” (Tummino 10929.) Dr. Jenkins, Director of the Office of New
Drugs, similarly reiterated his prior position adding, “I am not aware of any new data that
supports the need for an age restriction.” (Tummino 10931.) The Director and Deputy Director
of FDA’s Office of Surveillance and Epidemiology also observed that the BTC regime’s
program for “monitoring the compliance of the age restriction [by sending underage shoppers to
try to purchase Plan B without a prescription and reporting pharmacists to state boards of
pharmacy] is overly punitive and may have a negative impact on the availability of this product
OTC. . . . For other products with restricted distribution plans, these types of findings are
generally reported to the Agency, rather than professional licensing boards.” (Tummino 11077.)
On August 23, 2006, Commissioner von Eschenbach issued a memorandum stating that
he concluded that age 18, rather than age 17, is the “more appropriate cutoff point” for OTC Plan
B, based on the “well-established state and private-sector infrastructures to restrict certain
products to consumers 18 and older.” (Tummino 10866.) On August 24, 2006, Dr. Galson
issued a memorandum stating that the Plan B OTC switch application provided adequate
information that Plan B is safe and effective for OTC use in women age 17 and older. Dr.
Galson further stated that for the reasons outlined by Dr. von Eschenbach in his August 23, 2006,
38
memorandum, he determined that OTC Plan B should be restricted to women age 18 and older.
(Tummino 10868-74.) FDA staff has indicated that the timing of the approval of Plan B was
related in part to the pending Senate confirmation hearings of Dr. von Eschenbach. (Jordan Decl.
¶ 24.)
The August 24, 2006, action approved Plan B as a behind-the-pharmacy-counter
nonprescription drug for women age 18 and older who have and are willing to produce
government-issued photo identification. Women under 18 are required to provide a prescription
to obtain Plan B. In announcing the BTC regime, von Eschenbach emphasized that it would
continue to be illegal for women under 18 to obtain Plan B without a prescription. (Tummino
10866) (“Plan B® may not lawfully be made available without a prescription to [girls 16 and
younger] under section 503(b) of the Food, Drug, and Cosmetic Act.”). He also opined that
“[l]everaging well-established state and private-sector infrastructures [for tobacco products and
pseudoephedrine] will allow for comprehensive and effective enforcement of the age-based
restrictions.” (Id.)
Dr Galson’s approval letter announcing the BTC regime described a surveillance
program that Barr will implement which will utilize undercover shoppers to monitor compliance
by pharmacies with the age-restriction. As a condition of the approval, Barr is required to:
Conduct a “Point-of-Purchase Monitoring Program” to track how Plan B® is
being sold at the time of purchase, including using anonymous shoppers who will
be directed to visit locations where Plan B® is available and purchase the product.
Using the data collected, you will document and analyze the level of
comprehension of the Plan B® prescription age requirement and how it is handled
at the point of purchase. The program will be conducted twice in the first year and
annually thereafter. The sponsor will report repeat violators to the relevant State
Boards of Pharmacy.
(Tummino 10873.)
39
Evidently von Eschenbach and Galson viewed adopting state “infrastructures” for
tobacco and pseudoephedrine and the decoy shopper program as the appropriate enforcement
mechanism for the age restriction that provides a response to the prior Commissioner’s
enforcement concerns. (One year prior to announcement of the BTC regime, FDA
Commissioner Crawford had identified enforcement as one of the chief justifications for
considering general rulemaking regarding the FDA’s authority to switch a drug to non-
prescription status for one age group only. See August 26, 2005 Public Statement of Crawford
(http://www.fda.gov/bbs/topics/NEWS/2005/NEW01223.html (last checked on March 28, 2007)
(“And if FDA were to attempt to limit sale of an over-the counter product to a particular sub
population, would FDA be able to enforce such a limitation as matter of law, and could it do so
as a practical matter and then how?”)).
IV. The Government Accountability Office Investigation
In November 2005, the United States Government Accountability Office, at the request
of members of Congress, issued a report entitled “Decision Process to Deny Initial Application
for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual”
(hereinafter “GAO Rep.”). The GAO Rep. made a number of findings relevant to this case,
although the report considered only FDA actions prior to the May 6, 2004, Not Approvable letter
and “did not consider any communications that may have occurred between FDA officials and
other executive agencies.” (GAO Rep. at 4.) The GAO found four aspects of the FDA’s review
process to be unusual:
First, the Directors of the offices that reviewed the application, who would
normally have been responsible for signing the Plan B action letter, disagreed
with the decision and did not sign the Not-Approvable letter for Plan B. The
Director of the Office of New Drugs also disagreed and did not sign the letter.
Second, FDA’s high level management was more involved in the review of Plan
B than in those of other OTC switch applications. Third, there are conflicting
accounts of whether the decision not to approve the application was made before
40
the reviews of the application were completed. Fourth, the rationale for the
Acting Director’s decision was novel and did not follow FDA’s traditional
practices. The Acting Director stated that he was concerned about the potential
behavioral implications for younger adolescents of marketing Plan B OTC
because of their level of cognitive development and that it was invalid to
extrapolate data from older to younger adolescents. FDA review officials noted
that the agency has not considered behavioral implications due to differences in
cognitive development in prior OTC switch decisions and that the agency
previously has considered it scientifically appropriate to extrapolate data from
older to younger adolescents.
The Plan B decision was not typical of the other 67 proposed prescription-to-OTC
switch decisions made by FDA from 1994 through 2004. The Plan B OTC switch
application was the only one during this period that was not approved after the
Advisory Committee’s recommended approval. The Plan B action letter was the
only one signed by someone other than the officials who would normally sign the
letter. Further, there are no age-related marketing restrictions for any prescription
or OTC contraceptives that FDA has approved, and FDA has not required
pediatric studies for them. FDA identified no issues that would require age-
related restrictions in review of the original prescription Plan B new drug
application.
(GAO Rep. at 5-6.6)
V. The FDA’s Consideration of the Citizen Petition Was Heavily Intertwined With Its
Consideration of the Barr OTC Switch SNDA
Because Preven was withdrawn from the market, the Citizen Petition and the sNDA as
originally submitted by Barr both requested exactly the same action by the FDA. Clearly, then,
the signatories of the Citizen Petition are within the zone of interests affected by the FDA’s
decision on the Barr sNDA. Conversely, Barr is within the zone of interests affected by the
FDA’s decision on the Citizen Petition. At the following meetings conducted by the FDA, FDA
officials considered the Citizen Petition in tandem with the Barr sNDA: Office of the
Commissioner Meeting re: Rx to OTC switch of Plan B (June 5, 2002) (Tummino 30166-74);
Office of the Commissioner Meeting re: Rx to OTC switch of Plan B (Dec. 10, 2003) (Tummino
6
The GAO observed that “The Acting Director [Galson] acknowledged to GAO that considering adolescents’
cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application, and
other FDA officials told GAO that the rationale differed from FDA’s traditional practices.” Id.
41
30393-420). In its letter acknowledging its denial of the Citizen Petition on June 9, 2006, the
FDA reviewed extensively the evidence submitted by Barr in support of the sNDA, and
specifically linked the denial of the Citizen Petition to asserted deficiencies in data provided in
conjunction with the Barr sNDA. (Cit. Pet. Denial Ltr.) Indeed, the letter stated, “We made Dr.
Galson’s May 6, 2004 [Non-Approvable] letter to Barr available to the public. Thus, you were
on notice that we did not believe that even the applicant had submitted sufficient data to support
an OTC switch.” (Cit. Pet. Denial Ltr. at 7 n.9.) Moreover, the letter relied in part on lack of
data about “changes in sexual/contraceptive behaviors . . . due to Plan B,” (Cit. Pet. Denial Ltr. at
16), the same impermissible factor relied upon by Dr. Galson in his rejection of unrestricted
OTC status.
In addition, FDA officials charged with regulation of new drugs testified that the Citizen
Petition was considered by the FDA together with the Barr sNDA. (Galson Dep. 28:7-16 (“In
my mind, the issues is mixed of the citizens’ petition and the application, similar issues were
raised…”); Houn Dep. 17:10-14.) At an October Status Conference before the court, the
Counsel for the Defendant agreed that the Citizen Petition would stand or fall with the Barr
sNDA. (October 11, 2006 Hr’g Tr. 7.)
VI. The FDA’s Treatment of the Plan B OTC Switch Radically Departs from the
Manner In Which It Has Handled OTC Applications Concerning Other Drugs.
In denying the Citizen Petition and promulgating the BTC scheme, the FDA employed a
decision process that treated Plan B in a discriminatory manner compared to its treatment of all
other drugs. 7 In the past ten years, with the exception of Plan B, the FDA has never rejected an
OTC switch that was recommended by an Advisory Committee. (Def.’s Chart, Rx Switches
7
Indeed, the BTC regime discriminates against Plan B even among the smaller class of “products with restricted
distribution plans.” (Tummino 11077.)
42
(Proposed and Approved) to Nonprescription Status for the Last Ten Years, (hereinafter “10
Year Rx Switch Chart”), attached at Ex. E.)
The FDA does not routinely consult with the White House about an OTC switch
application (McClellan Dep. 133:7-9) or decide OTC switch applications in a manner designed
to appease the constituents of the President of the United States, but did both when it came to
Plan B. (McClellan Dep.131:15-132, 127:10-15, 138:11-19, 140:19-141:13; Houn Dep. 59:12-
60:6; Kweder Dep. 56:8-58:19.) In the past ten years, the Commissioner of the FDA has not
made a determination on an OTC switch application before the reviews were complete except for
Plan B. (GAO Rep. at 31.)
In the past ten years, no OTC switch application has been decided at the level of the
Director of the Center for Drug Evaluation and Research (CDER). (GAO Rep. at 30; Galson
Dep. 35:22-36:3, 36:14-19.) With the exception of one other drug and Plan B, the FDA has not
received an Actual Use Study that included persons under the age of 18, even for numerous
drugs that are available without age restriction. (Def.’s Resp. to Interrogs. 1-12 (indicating drugs
approved for Rx to OTC switch between 1/1/01 and 12/31/05 (hereinafter “Interrog. 5 Year
Chart”) attached hereto at Ex. E; see also 10 Year Rx Switch Chart (indicating lack of FDA
request for pre-marketing data on adolescents).) The FDA has approved numerous OTC
switches without requiring or approving any Label Comprehension study from the sponsor.
(Interrog. 5 Year Chart.) The FDA has never, prior to Plan B, required a non-prescription drug
to be sold only at pharmacies. Many of these drugs that are available for sale in retail stores
other than pharmacies are known to be abused both by minors and adults, including some such as
aspirin, Ibuprofen, and Acetaminophen which cause hundreds of deaths each year in the U.S.
(Tummino 30757-58, 31086; Jordan Decl. ¶ 21; Grimes Decl. ¶ 10(E).) Other OTC drugs, such
43
as dextromethorphan, are abused by taking higher than approved dosages in order to experience
side effects of over dosage. (Rosebraugh Dep. 190:11-191:2, July 18, 2006.)
Nor in the last ten years has the FDA requested that a manufacturer provide data on
adolescents in support of an OTC application.8 (10 Year Rx Switch Chart.) Instead, FDA
scientists routinely extrapolate from data about one age group to another age group as the
professional staff of the FDA advocated in the case of Plan B. But the FDA refused to do so in
the case of Plan B.
The FDA cannot identify another occasion in which it considered how its approval of a
drug would effect on personal behavior of those who would use it. (GAO Rep. at 22; Tummino
31097-98; Jenkins Dep. 103:8-11, 105:5-107:13.) Indeed, the FDA did not consider the effects
on sexual behavior of men when it approved Viagra and other erectile dysfunction drugs, and
approved Plan B itself as a nonprescription drug for sale to men 18 and over without any data
concerning, much less consideration of, the effect it might have on the sexual or contraceptive
behavior of such men. (Jenkins Dep. 125:18-126:12; see also Jordan Decl. ¶ 20.)
The FDA has approved OTC switches for numerous prescription drugs and classes of
prescription drugs which have greater toxicity than Plan B. (Grimes Decl. ¶ 10(E); see also Houn
Dep. 120:18-121:17, July 20, 2006.) In other words, many OTC drugs could cause more severe
side effects even when they are used according to approved directions than the correct or
incorrect use of Plan B could ever cause. (Grimes Decl. ¶ (10)E; Tummino 31086; see also
Houn Dep. 127:2-128:12.) Similarly, many OTC drugs pose special risks for certain populations
(including certain age groups). (See, e.g., Jordan Decl. ¶ 21) In no case have any of these OTC
8
Although the 10 Year Rx Switch Chart indicates that FDA has on occasion requested adolescent data in the form
of Phase IV studies, Phase IV studies are follow-up studies conducted after the drug has been approved and after it
is being marketed and sold OTC. These are not studies that are required, or even possible to conduct, prior to
approval.
44
drugs been approved with a specific restriction for such populations. (Jenkins Dep. 113:2-16.)
Rather, the FDA has always addressed concerns about specific populations by requiring label
warnings. (Jenkins Dep. 113:7-16; Tummino 31027, 31097.) For example, aspirin is not
recommended for use by children or adolescents with viral infections, because of the risk of
developing Reye’s Syndrome – a potentially fatal illness. (Jordan Decl. ¶ 21.) Nevertheless, it is
widely available to for unrestricted purchase, including by adolescents and by parents who intend
to purchase it for their children. Before its action on Plan B, the FDA has never restricted a non-
prescription drug product based on age but has always addressed concerns about inadequate data
for younger ages by including an age warning on the drug label. (GAO Rep. at 30; Jenkins Dep.
113:6-16; Tummino 31027, 31031-32, 31086, 31097; Jordan Decl. ¶21.) Similarly, the FDA has
approved OTC switches for numerous prescription drugs and classes of prescription drugs whose
directions for approved use are far more complicated than the directions for Plan B. (Jenkins
Dep. 101:5-18.)
As a further indication of the FDA’s unprecedented treatment of Plan B, some FDA drug
regulators are concerned that the BTC regime establishes a new precedent justifying similar age
restricted non-prescription status for every drug for which actual use and label comprehension
studies for younger ages are not submitted or are insufficient, as well as reexamination of both
contraceptive and non-contraceptive OTC drugs and devices where age concerns are reflected
currently in a warning label. (Tummino 30650, 31027, 31086, 31097, 31031-32; Jenkins Dep.
112:13-113:19.)
VII. The BTC Regime Reinforces Outmoded Stereotypes of Women.
Plan B is approved for use only by women. (Tummino 10876-84.) The FDA’s rejection
of unrestricted OTC status for Plan B and the structure of the BTC regime both perpetuate
45
outmoded stereotypes of women as less capable of making rational judgments than men and as
incapable of following simple instructions. (DeMarco Decl. ¶¶ 9-10; Brown Decl. ¶¶ 8-9.)
Specifically, requiring adult women to obtain Plan B from behind the pharmacy counter
by showing government-issued proof of age perpetuates the outmoded view that women’s efforts
to control their own fertility should be kept out of the public eye and are in some way shameful.
(DeMarco Decl. ¶¶ 8-9; Mahoney Decl. ¶ 4; Tummino Decl. ¶ 5; Grimes Decl. ¶ 12.)
Controlling the point of sale of Plan B as a non-prescription product for adults perpetuates the
outmoded stereotype that adult women still require the guidance of pharmacy workers in order to
be able to use Plan B effectively because they are less capable than adult men of following
instructions. (DeMarco Decl. ¶¶ 8-9.)
Moreover, although Plan B was never tested or reviewed by the FDA in connection with
the OTC switch for any use by males, the FDA nevertheless approved the product for men age
18 and over. Indeed, in the past ten years, no other product has been switched to non-
prescription use for both males and females as to which the FDA required studies by the sponsor
for one sex but not the other. (See 10 Year Rx Switch Chart). This reinforces stereotypes of
women as uneducated and unintelligent by promoting the view that such adult men are so
superior to women that they can be entrusted to use Plan B appropriately even though there is no
approved use of Plan B for men. (DeMarco Decl. ¶ 9.) By requiring evidence that non-
prescription availability of Plan B would not affect women detrimentally by changing their
contraceptive behavior before approving it for women, while simultaneously approving non-
prescription availability of Plan B for adult men without any studies showing how Plan B’s
availability affects men’s sexual behavior,9 the BTC regime reinforces an outmoded stereotype
9
For example, perhaps the OTC availability of Plan B to adult men will discourage them from using condoms
during sex.
46
of women as less capable than men of making their own sexual and contraceptive decisions.
(DeMarco Decl. ¶ 10.) Furthermore, by rejecting as insufficient evidence that non-prescription
availability of Plan B would not affect adolescent women detrimentally by changing their
contraceptive behavior, while simultaneously approving non-prescription availability of Plan B
for adult men without any studies showing how availability affects men’s sexual behavior, the
BTC regime reinforces an outmoded stereotype of women as less capable than men of making
their own sexual and contraceptive decisions.
Indeed the BTC regime so strongly reinforces the stereotype of women as less capable
than men of making sexual and contraceptive decisions that FDA officials who rejected full OTC
availability were unable to state what evidence would suffice to meet their concerns about any
younger women’s sexual and contraceptive behavior. (Tummino 30649-51, 31027, 31086.) On
the other hand, these same officials evidently viewed all adult men as so indisputably capable of
making sexual and contraceptive decisions that no evidence at all is needed to make Plan B
available to them. Consistent with the FDA’s employment of sexual stereotypes in its treatment
of Plan B, when erectile dysfunction drugs were approved by the FDA in 1998 no examination
was undertaken whatsoever on these drugs’ effects on men’s sexual and contraceptive behavior.
(Jenkins Dep. 125:18-126:11.)
APPLICABLE LEGAL STANDARD
Plaintiffs are entitled to summary judgment if the pleadings, depositions, answers to
interrogatories and admissions on file, together with affidavits, show that there is no genuine
issue as to any material fact and that the moving party is entitled to judgment as a matter of law.
Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-248 (1986). In
47
determining whether there is a genuine issue of material fact, the court must resolve all
ambiguities, and draw all inferences in favor of the non-moving party. United States v. Diebold,
Inc., 369 U.S. 654, 655 (1962) (per curiam); GlobalNet Financial.Com, Inc. v. Frank Crystal &
Co., Inc., 449 F.3d 377, 382 (2d Cir. 2006). The party opposing summary judgment, however,
“may not rest upon the mere allegations or denials of the adverse party’s pleading, but . . . must
set forth specific facts showing that there is a genuine issue for trial.” Fed. R. Civ. P. 56(e). See
also GlobalNet Financial.Com, Inc., 449 F.3d at 382. The non-moving party may not rely upon
speculation, “but instead must offer some hard evidence showing that its version of the events is
not wholly fanciful.” D’Amico v. City of New York, 132 F.3d 145, 149 (2d Cir. 1998).
ARGUMENT
I. Plaintiffs Have Standing to Challenge the FDA’s Rejection of Unrestricted OTC
Status for Plan B.
It is well settled that persons who suffer injury-in-fact caused by government action have
Article III standing to challenge that action, Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61
(1992), and have standing to challenge administrative agency action so long as they are within
the “zone of interests” of the relevant statute. “Qualified plaintiffs include not only those who
are themselves the ‘subject of the contested regulatory action,’ Clarke [v. Sec. Indus. Ass’n], 479
U.S. [388,] at 399 [(1987)], but also those whose interests are ‘not so marginally related to or
inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that
Congress intended to permit the suit.’ Id.” Amgen Inc. v. Smith, 357 F.3d 103, 108 (D.C. Cir.
2004). Plaintiffs – all of whom seek unrestricted OTC status for Plan B for women of all ages in
order to enhance their ability to make Plan B accessible to and more effective for women who
need it, and some of whom seek OTC status to make Plan B more accessible for themselves – are
48
clearly within the “zone of interests” of the Food, Drug and Cosmetic Act. See, e.g., Stauber v.
Shalala, 895 F. Supp. 1178, 1187 (W.D. Wis. 1995) (“The Food, Drug and Cosmetic Act creates
legal rights or interests for consumers.”).
In addition, Plaintiffs have standing not only in their own right, but also third-party
standing to assert the constitutional rights of consumers of Plan B. Eisenstadt v. Baird, 405 U.S.
438, 446 (1972) (holding that a person distributing contraceptives to women had standing to
assert women’s constitutional right of access to contraception); Carey v. Population Servs., Inc.,
431 U.S. 678, 684 (1979) (vendor of contraceptives had standing to assert rights of those to
whom it sold contraceptives because it was among “‘vendors and those in like positions [who]
have been uniformly permitted to resist efforts at restricting their operations by acting as
advocates for the rights of third parties who seek access to their market or function.’”) (quoting
Craig v. Boren, 429 U.S. 190, 195 (1976); Craig, 429 U.S. at 194-95 (beer vendor could assert
rights of its customers to be free of gender-based discrimination).
A. Plaintiffs Have Standing in Their Own Right.
Each of the Plaintiffs has standing to bring claims under the APA because each has
suffered injury-in-fact, because that injury is caused by the FDA’s failure to approve Plan B for
unrestricted OTC use, and because their injury will be redressed by an injunction requiring the
FDA to make Plan B available OTC without any age restriction. Under the APA, any person is
entitled to bring suit who is “suffering a legal wrong because of agency action.” 5 U.S.C. § 702.
Specifically, each of the individual Plaintiffs who are coordinators of the Morning After
Pill Conspiracy is injured because her ability to distribute Plan B to women under 18 is subject to
criminal penalties. Because a prescription is required for dispensation of Plan B to women under
49
18, transfer of Plan B to a woman under 18 violates the misbranding prohibition of the Food,
Drug, and Cosmetic Act, codified as 21 U.S.C. § 352,10 as stated by the Commissioner of the
FDA. (Tummino 10866.) (“Plan B® may not lawfully be made available without a prescription
to [“girls 16 and younger”] under section 503(b) of the Food, Drug, and Cosmetic Act.”). Given
the FDA’s expressed concern about enforcement of the age restriction, see supra at 38-39,
Plaintiffs reasonably fear prosecution if they transfer Plan B to a woman under the age of 18.11
These Plaintiffs are also injured because their own access to Plan B is contingent on their
disclosure of name, address, and age to a pharmacist or pharmacy employee in order to obtain
the product under the BTC regime. They are also injured because the BTC regime makes Plan B
unavailable for purchase during hours when a pharmacist is not available to dispense it, despite
the fact that as an “emergency” drug, Plan B is most effective when taken as soon as possible.
(Jordan Decl. ¶ 4; Brown Decl. ¶¶ 3, 9; DeMarco Decl. ¶¶ 6-7.) The two organizational
plaintiffs are injured because they are impeded in their missions of expanding access to
emergency contraception. (See, e.g., Jordan Decl. ¶ 17; see also supra at 15.) The individual
young women Plaintiffs, and their Plaintiff parents who sue on their behalf, are injured because
each young woman wants to be able to obtain Plan B, in the event that it would be needed,
without a prescription and without restriction on its point of sale, in order to minimize her risk of
unintended pregnancy.12
10
Misbranding is made a crime by 21 U.S.C. § 331 (“Prohibited acts”), for which fines and imprisonment are
prescribed by 21 U.S.C. § 333(a).
11
In addition, transfer of Plan B to a person who requires a prescription for it, including any woman under the age
of 18 or any woman without sufficient proof that she is 18 or older, triggers criminal liability under state statutes
which incorporate the prescription status of drugs. See, e.g., 21 U.S.C. §§ 353(b)(1), 333(a), 333(b) (2005); §
465.015, Fla. Stat. (2004).
12
It is undisputed that the risk of pregnancy increases the longer a woman waits to use Plan B. The BTC regime
will cause some women to delay using Plan B. The increased risk of unwanted pregnancy is sufficient injury-in-fact
to satisfy Article III standing requirements. See Baur v. Veneman, 352 F.3d 625, 633 (2d Cir. 2003) (“[T]he courts
of appeals have generally recognized that threatened harm in the form of an increased risk of future injury may serve
as injury-in-fact for Article III standing purposes.”).
50
B. Plaintiffs Have Third-Party Standing to Assert the Rights of Women Who
Need Plan B.
The Plaintiffs also have third-party standing to assert the rights of women for whom the
Plan B prescription requirement is a barrier to their ability to use the drug in a timely and
effective manner. This is because they have a sufficiently “close relationship” with such women,
see Eisenstadt, 405 U.S. at 445 (holding that lay person who had given contraceptive to a woman
had standing to assert equal protection and privacy rights of women seeking contraception: “And
so here the relationship between Baird and those whose rights he seeks to assert is not simply
that between a distributor and potential distributees, but that between an advocate of the rights of
persons to obtain contraceptives and those desirous of doing so. The very point of Baird’s giving
away the vaginal foam was to challenge the Massachusetts statute that limited access to
contraceptives.”); Craig, 429 U.S. at 195 (licensed vendor of beer has standing to assert equal
protection rights of those who wish to purchase beer in part because “vendors and those in like
positions have been uniformly permitted to resist efforts at restricting their operations by acting
as advocates of the rights of third parties who seek access to their market or function.”), and
because there are obvious hindrances to such women bringing their own litigation against the
FDA. These hindrances include: 1) the same financial limitations that make it difficult for them
to obtain a prescription for Plan B from a physician; 2) the short duration of time during which
they need Plan B (Jordan Decl. ¶ 4), and therefore the limited period during which they have
standing in their own right to seek injunctive relief;13 and 3) the breach of confidentiality that
13
A woman for whom the Plan B prescription requirement was a barrier who became pregnant as a result of the
barrier might be able to bring a suit for damages against the FDA under, for example, the Little Tucker Act. 28
U.S.C. § 1346(a). But she would be unlikely to have standing to seek injunctive or declaratory relief because she
would have difficulty asserting that her need for emergency contraception is sufficiently “capable of repetition,” Roe
v. Wade, 410 U.S. 113, 125 (1973). See also Los Angeles v. Lyons, 461 U.S. 95, 111 (1983) (“Absent a sufficient
likelihood that [the plaintiff] will again be wronged in a similar way, [the plaintiff] is no more entitled to an
injunction than any other citizen . . . . ); Am. Postal Workers Union v. Frank, 968 F.2d 1373, 1376 (1st Cir. 1992)
(stating that even where past injury suffered by plaintiffs confers standing to bring an action for damages, “it is an
insufficient predicate for equitable relief”).
51
would be required for them to bring suit.
II. The District Court Has Jurisdiction over Plaintiffs’ Claims and the Court of
Appeals Lacks Such Jurisdiction.
On December 22, 2005, the Court reserved decision on the issue of whether this Court or
the Court of Appeals is the appropriate forum for the cause of action based on the FDA’s action
on the Barr sNDA and sought clarification from Plaintiffs as to whether they would oppose
transfer to the Court of Appeals. On January 27, 2006, Plaintiffs submitted to the Court a brief
opposing transfer of this case to the Court of Appeals, and Plaintiffs now re-assert that this Court
is the appropriate forum for all causes of action contained in Plaintiffs’ Fifth Amended
Complaint.
This Court has federal question jurisdiction under 28 U.S.C. § 1331 over Plaintiffs’ Fifth
Amended Complaint, which raises claims under the APA, including constitutional claims (5
U.S.C. § 706(2)(B)), a claim of arbitrary and capricious agency action (5 U.S.C. § 706(2)(A)),
and a claim that the agency has exceeded its statutory authority (5 U.S.C. § 706(2)(C)). Judicial
review is established by section 703 of the APA which provides that:
The form of proceeding for judicial review is the special statutory review
proceeding relevant to the subject matter in a court specified by statute or, in the
absence or inadequacy thereof, any applicable form of legal action, including
actions for declaratory judgments or writs of prohibitory or mandatory injunction
or habeas corpus, in a court of competent jurisdiction.
5 U.S.C. § 703. It is “well established” that Section 703 “does not confer upon a court of appeals
any additional jurisdiction not expressly authorized by a statutory grant of power.” Noland v.
U.S. Civil Serv. Comm’n, 544 F.2d 333, 334 (8th Cir. 1976). See also In re Sch. Bd. of Broward
County, Fl., 475 F.2d 1117, 1119 (5th Cir. 1973) (holding that court of appeals is not appropriate
initial forum “unless specially authorized by statutory grant of power.”).
52
The Government has previously suggested that this case belongs in a federal appeals
court, citing 21 U.S.C. § 355(h). That statute, contained in the Food, Drug and Cosmetic Act,
states in relevant part:
An appeal may be taken by the applicant from an order of the Secretary refusing
or withdrawing approval of an application under this section. Such appeal shall
be taken by filing in the United States court of appeals for the circuit wherein
such applicant resides or has his principal place of business, or in the United
States Court of Appeals for the District of Columbia Circuit, within sixty days
after entry of such order, a written petition praying that the order of the Secretary
be set aside.
21 U.S.C. § 355(h). By its terms, section 355(h) confers jurisdiction on courts of appeals to
review orders refusing to approve or withdrawing approval of “applications under this section.”
Id. “This section” means 21 U.S.C. § 355, which provides that “[a]ny person may file with the
Secretary an application with respect to any [new] drug . . .”. 21 U.S.C. § 355(b). Moreover,
jurisdiction is conferred on courts of appeals only with respect to appeals filed “by the applicant”
who filed the new drug application (NDA). Thus, only an applicant who has actually filed an
NDA may appeal directly to a court of appeals from an adverse order regarding that NDA.
Because none of the Plaintiffs is an applicant who has filed an NDA with the FDA that has been
denied, jurisdiction does not lie under 335(h) in the United States courts of appeals.
This plain meaning of section 355(h) is reinforced by several court decisions that have
examined whether cases related to actions taken by the FDA regarding drugs were properly
before a district court or a court of appeals. The leading case is Cutler v. Hayes, 818 F.2d 879
(D.C. Cir. 1987). Cutler was “a challenge by consumers of over-the-counter (OTC) drugs to the
program undertaken by the Food and Drug Administration (FDA) comprehensively to review
these drugs for their safety and effectiveness.” Id. at 882. The Cutler Court described review of
FDA actions as follows:
53
The FDC Act contains no single, overarching provision governing judicial review.
Instead, discrete agency actions are subject to specialized review provisions. See,
e.g., 21 U.S.C. § 355(h) (1982) (review by court of appeals of agency’s
disapproval of new-drug application); id. § 360g (review by court of appeals of
regulations classifying devices); id. § 371(f) (review by court of appeals of orders
issued pursuant to provisions enumerated in § 371(e)). Agency action taken
under sections silent in this respect are directly reviewable in a district court under
some appropriate head of its jurisdiction, for courts of appeals have only such
jurisdiction as Congress has chosen to confer upon them. Shaw v. United States,
93 U.S. App. D.C. 300, 302, 209 F.2d 811, 813 (1954); Diamond Shamrock Oil &
Gas Corp. v. Commissioner, 422 F.2d 532, 534 (8th Cir.1970).
Id. at 887 n.61 (emphasis added) (parallel citations omitted). Moreover, Cutler observes that:
Section 355(h), however, authorizes review by a court of appeals only in cases
challenging disapprovals of new-drug applications, and is therefore inapplicable
[elsewhere]. Cf. Weinberger v. Bentex Pharmaceuticals, Inc., supra note 22, 412
U.S. at 651, 93 S.Ct. at 2493, 37 L.Ed.2d at 240-241 (interpreting § 355(h)
narrowly and endorsing district-court jurisdiction to hear appeals from orders
affecting new-drug status). We note, too, that the Supreme Court has implicitly
approved the exercise of district-court jurisdiction over similar claims pertaining
to FDA’s enforcement duties under § 355. See Heckler v. Chaney, 470 U.S. 821,
824-825, 105 S.Ct. 1649, 1652, 84 L.Ed.2d 714, 719-720 (1985). We thus
conclude that because in this case no statute commits direct review of FDA new
drug regulations to this court . . . the District Court properly exercised
jurisdiction.
Id. (parallel citations omitted). Here, as in Cutler, it is even arguable that the OTC switch
application does not actually arise under section 355 at all, for it is 21 U.S.C. § 353(b)(3) that
authorizes the Secretary “by regulation [to] remove drugs subject to section 355 of this title from
the [prescription] requirements of paragraph (1) of this subsection when such requirements are
not necessary for the protection of the public health,” and section 353 does not provide for direct
court of appeals review of applications seeking such OTC switches.14
Following Cutler, courts have uniformly narrowly construed the scope of jurisdiction
conferred on courts of appeals by section 355(h). For example, the First Circuit in Bradley v.
14
It appears that OTC switch applications arise under both sections 353 and 355, and so it is unclear whether an
OTC switch application would fall under section 355(h) for the purposes of establishing appellate court jurisdiction
in a case where the applicant seeks to challenge the FDA’s decision. See 21 U.S.C. § 353(b). Cf. 21 C.F.R. § 330
(indicating as sources of its regulatory authority sections 353 and 355 of Title 21 of the U.S. Code, among several
other sections).
54
Weinberger, 483 F.2d 410 (1st Cir.1973), found that “[t]he right to petition the court of appeals
for review under 21 U.S.C. § 355(h) is available only to a drug-marketing applicant after an
order refusing or withdrawing approval of a drug application.” Id. at 413 n.1 (emphasis added).
As in this case, the controversy in Bradley involved a challenge by parties other than the drug’s
manufacturer to proposed changes in the drug’s labeling. Similarly, in Genentech, Inc. v.
Bowen, 676 F. Supp. 301 (D.D.C. 1987), the district court considered a challenge by certain drug
manufacturers to the FDA’s redesignation of the drug Humatrope (made by another
manufacturer) as an “orphan drug.” The court observed:
[I]t is unlikely that a court of appeals would have jurisdiction under 21 U.S.C. §
355(h) to review the validity of the Humatrope designation. Subsection (d) of 21
U.S.C. § 355 enumerates seven grounds for denying a new drug application, and
subsection (h) limits the courts of appeals’ direct review jurisdiction to denials
“under this subsection.” A denial based on Humatrope’s orphan drug exclusivity
would be based on 21 U.S.C. § 360cc(a) (which is silent on the matter of judicial
review), not on a ground enumerated in 21 U.S.C. § 355(d). Given the courts’
narrow construction of jurisdiction under 21 U.S.C. § 355(h), it is likely that
movants would be rebuffed if they attempted to challenge the Humatrope
designation in a court of appeals.
Id. at 311 (internal citations omitted). Here, the August 24, 2006, approval of BTC status for
Plan B for women over 18 and denial of non-prescription status for women 17 and younger, if it
indeed falls under section 355 at all, rather than section 353, and regulations promulgated under
section 353, was an approval of the sponsor’s application for split label access. As the Agency’s
action was not a denial of the sponsor’s application under 355(d),15 as in Genentech, a court of
appeals will likely “rebuff” an effort at direct review, even by the manufacturer itself. See
15
Grounds for refusing an application under 21 U.S.C. § 355(d) include that studies have not demonstrated that the
drug is safe for use, that the methods of studying a drug’s safety are unpersuasive, that the manufacture and
processing of a drug are inadequate to preserve its quality and purity, that a drug is not effective, and that the
labeling is false or misleading. Moreover, if the enumerated clauses do not apply, the drug is to be approved. Id.
The subsection also defines the term “substantial evidence” to mean “evidence consisting of adequate and well-
controlled investigations, including clinical investigations, by experts qualified by scientific training and experience
to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded
by such experts that the drug will have the effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” Id.
55
generally Barnes v. Shalala, 865 F. Supp. 550, 555-56 (W.D. Wis. 1994) (third-party challenge
to approval of bovine growth hormone does not implicate exclusive jurisdiction of court of
appeals under 355(h), in part because challenge to approval is not equivalent to challenge to
denial of approval or withdrawal of approval).
Therefore only the manufacturer of Plan B can invoke the jurisdiction of a court of
appeals under section 355(h), and then only if the NDA it has submitted has been denied (which
it has not been), and if it was denied for a reason enumerated in section 355(d), and if an OTC
switch application arises under section 355 rather than under section 353 and regulations
promulgated under it. But, as explained in more detail below, Plaintiffs do not and cannot stand
in for Barr (and do not qualify as “applicants” under 355(h) by virtue of the Citizen Petition filed
by one Plaintiff), and thus, even if Barr could surmount the several obstacles to court of appeals
jurisdiction, Plaintiffs cannot. Jurisdiction should therefore remain with this Court, and the case
should not be transferred.
A. Plaintiffs Cannot Assert the Rights of Barr and Thereby Invoke the
Jurisdiction of the Court of Appeals.
It is well settled that, in order for a party to have standing to represent the interests of a
third-party not before the Court, the party must establish its own standing, and then also establish
the prudential components of third-party standing:
The determination whether a plaintiff has standing to assert the rights of third parties has
constitutional and prudential components. Singleton v. Wulff, 428 U.S. 106, 112 (1976). First,
as is the case with any plaintiff, she must meet the constitutional prerequisites of standing: (1)
injury-in-fact, (2) causation, and (3) redressability. Steel Co. v. Citizens for a Better Env’t 523
U.S. 83, 102-03 (1998) (identifying this triad as the “irreducible constitutional minimum of
standing” (internal quotation marks omitted)). In addition, she must satisfy “prudential”
56
limitations on third-party standing: (1) a “close relation with the third party” and (2) “some
hindrance to the third party’s ability to protect his or her own interests.” Powers v. Ohio, 499
U.S. 400, 411 (1991); Sec’y of State v. Joseph H. Munson Co., 467 U.S. 947, 956 (1984); Lewis
v. Thompson, 252 F.3d 567, 584 (2d Cir. 2001) (parallel citations omitted). See also Kowalski v.
Tesmer, 543 U.S. 125, 130 (2004) (requiring a party seeking third-party standing to make two
showings in addition to demonstrating Article III standing: “First, we have asked whether the
party asserting the right has a ‘close’ relationship with the person who possesses the right.
Powers, 499 U.S. at 411. Second, we have considered whether there is a ‘hindrance’ to the
possessor’s ability to protect his own interests. Ibid.”) (parallel citations omitted).
Here, none of the Plaintiffs can assert third-party standing to represent the interests of
Barr as an applicant for the OTC switch for Plan B because (1) they lack a “close relationship
with” Barr; and (2) they are unable to present evidence of any hindrance to Barr’s ability to
protect its own interest. First, Plaintiffs have no relationship with Barr, let alone a close
relationship, different than the relationship that any member of the public has to Barr. Such an
attenuated relationship has not been considered by courts to be legally sufficient to establish
third-party standing.
For instance, in Kowalski, the plaintiffs were attorneys who sought, unsuccessfully, to
assert the rights of future, hypothetical clients – clients who they intended to represent in the
future. Kowalski, 543 U.S. 130. The Supreme Court found that the attorneys in Kowalski did
not have a sufficiently “close relationship” with future clients to establish third-party standing:
“The attorneys before us do not have a ‘close relationship’ with their alleged ‘clients’; indeed,
they have no relationship at all.” 543 U.S. at 131. Here, Plaintiffs have even less of a “close
relationship” to Barr than the attorneys in Kowalski had with their future clients. Like the
57
attorneys in Kowalski, Plaintiffs have no commercial, financial, or associational relationship to
Barr, and certainly no fiduciary or confidential relationship tantamount to that of an attorney and
her client.16 Indeed, the Protective Order filed in this case designed to protect Barr’s confidential
commercial information demonstrates the distance between Plaintiffs and Barr. Under Kowalski,
Plaintiffs have no hope of establishing the requisite “close relationship” to Barr. Kowalski, 543
U.S. at 130-31.
Second, Plaintiffs do not have third-party standing to represent Barr because they cannot
demonstrate that there is any hindrance to Barr asserting its own interests and rights concerning
the denial of Barr’s initial request to switch Plan B to unrestricted OTC status. Indeed, Barr has
submitted a declaration to the Court declining to specify its reasons for failure to sue the FDA
over its actions regarding Plan B. (See Carole Ben-Maimon, M.D., Decl. dated January 23, 2005
(Doc. 92A) (attached to Pls.’ Mem. in Opp. to Transfer to Ct. of Appeals (Doc. 92).) But Barr
has sued the FDA before, see, e.g., In re Barr Labs., Inc., 930 F.2d 72 (D.C. Cir. 1991); Barr
Labs., Inc. v. Thompson, 238 F. Supp. 2d 236 (D.D.C. 2002); Barr Labs., Inc. v. Harris, 482 F.
Supp. 1183 (D.D.C. 1980), so Plaintiffs (and the Court) are left to infer that Barr has financial or
commercial reasons for avoiding litigation about Plan B. In any event, there is absolutely no
evidence, and none is available to Plaintiffs, that some factor other than a strategic decision not
to sue the FDA “hinders” Barr from asserting its own rights and interests. Such a strategic
decision not to litigate cannot possibly form the basis for “hindrance” sufficient for third-party
standing, else “hindrance” would exist any time the third party chooses not to bring suit itself.
16
In fact, it would inconsistent for the FDA to argue that Plaintiffs do have a close relationship with Barr, given
that in their letter dated June 9, 2006 denying approval of Plaintiffs’ citizen petition, the FDA wrote: “As you lack
any commercial, financial, associational, fiduciary, or confidential relationship with Barr, you are not privy to Barr’s
legal, business, or scientific concerns, and therefore cannot represent its interests, which may well be in conflict with
your own.” (Cit. Pet. Denial Ltr. at 17.)
58
Accordingly, Plaintiffs cannot assert third-party standing to represent Barr, the sNDA
applicant for Plan B.
B. Plaintiff and Citizen Petitioner Association of Reproductive Health
Professionals (ARHP) Is Not an “Applicant” under Section 355 and
Therefore Cannot Invoke the Jurisdiction of the Court of Appeals.
Plaintiff ARHP is a signatory of the Citizen Petition seeking unrestricted OTC status for
Plan B. The FDA acknowledged denial of the Citizen Petition on June 9, 2006. However,
because Plaintiff ARHP’s Citizen Petition does not constitute an application under section 355 of
the Food, Drug and Cosmetic Act, the jurisdiction explicitly granted to courts of appeals under
subsection 355(h) is inapplicable to ARHP. (See Henley v. F.D.A., 873 F. Supp. 776, 779-80
(E.D.N.Y. 1995) (district court exercising jurisdiction over denial of citizen petition), aff’d, 77
F.3d 616 (2d Cir. 1996). Thus, jurisdiction over denial of a Citizen Petition does not lie in the
court of appeals because a Citizen Petition is not an “application” under 21 U.S.C. § 355.
Rather, the Citizen Petition exists by virtue of the APA, not the Food, Drug and Cosmetic Act:
“APA § 553(e) requires every agency to ‘give an interested person the right to petition for the
issuance, amendment, or repeal of a rule.’ The FDA regulation that grants this right is found at
21 C.F.R. § 10.30.” Id.
Moreover, citizen petitions also can request a much broader range of agency actions than
action on a drug or set of drugs. The relevant FDA regulation, 21 C.F.R. § 10.30, authorizes any
person, whether that person is a U.S. citizen or not, to request the FDA Commissioner to “issue,
amend, or revoke a regulation or order or take or refrain from taking any other form of
administrative action.” 21 C.F.R. § 10.30 (a), (b) (1994). The Citizen Petition requesting OTC
status for emergency contraceptive drugs initially asked the FDA to order such status for all such
59
drugs – not only Barr Labs’ product, Plan B. This is hardly the type of application that would
ever be filed by a drug manufacturer.
In addition, the entire FDA citizen petition process is differently structured than the NDA
process described in section 355. For example, as to a citizen petition:
Within 180 days of receipt of the petition, the Commissioner must respond by 1)
approving the petition, 2) denying the petition, or 3) providing a tentative
response indicating the reasons for postponing a final response (e.g., more time or
more information is needed). While there is no requirement that the
Commissioner hold hearings with regard to the petition, the Commissioner must
consider the petition and must give written notice of the decision accompanied by
an explanatory statement.
Id. (emphasis added). In contrast, an applicant under section 355 must, within 180 days after the
filing of an application, receive either approval or an opportunity for a hearing. 21 U.S.C. §
355(c)(1). Similarly, while the grounds for approval or denial of a citizen petition are framed
quite broadly, id. (“The Commissioner must grant the petition upon a determination that the
following factors are all present: 1) relevant information was not adequately considered; 2) the
position is not frivolous; 3) sound public policy grounds support reconsideration; 4) public
interests do not outweigh reconsideration.”), the grounds for denying an NDA submitted under
section 355 are quite detailed and specific, including, for example, failure to include “patent
information prescribed by” 355(b). See generally 21 U.S.C. § 355(d) (specifying seven distinct
and specific grounds for failure to approve an NDA). Likewise, the application processes
delineated in 21 C.F.R. § 10.30 with regard to a Citizen Petition and under 21 U.S.C. § 355(b)
for a new drug application require completely different types of supporting information and
materials. Compare 21 C.F.R. § 10.30 with 21 U.S.C. § 355(b).
For all the foregoing reasons, Plaintiff ARHP’s standing as a signatory of the Citizen
Petition does not arise under section 355 of the Food, Drug and Cosmetic Act, and hence the
60
special jurisdiction conferred on courts of appeals by subsection 355(h) is unavailable. See also
Henley, 873 F. Supp. 776 (exercising jurisdiction over denial of citizen petition).17
III. Plaintiffs Are Entitled to Summary Judgment on Their Four Constitutional Claims.
In the Fifth Amended Compliant, Plaintiffs assert that the BTC regime violates four
constitutional mandates.18 First, it violates the right to decisional privacy by imposing
unjustified barriers on women’s access to Plan B. Second, it violates the right to equal protection
of the law by classifying and discriminating on the basis of the fundamental right to use
contraceptives by unjustifiably treating the contraceptive drug Plan B in a discriminatory and
invidious manner. Third, it violates equal protection of the law because it discriminates on the
basis of sex by unjustifiably treating a drug approved for use only by women differently from
other drugs and in a manner that reinforces outmoded stereotypes of women. Fourth, it violates
women’s right to informational privacy by unjustifiably requiring disclosure of private
information in order to obtain Plan B. In each instance, the government must come forward, at a
minimum, with an “exceedingly persuasive” or “compelling” justification for the violation. No
such justification can be found in the record before the Court. Accordingly, Plaintiffs should be
granted summary judgment on each of these claims.
17
All the Plaintiffs have standing to sue based on their own injury caused by the FDA’s failure to approve Plan B
for unrestricted OTC use, and which will be redressed by an injunction requiring the FDA to make Plan B OTC
without an age restriction. (See supra at 48-49) The Plaintiffs also have third-party standing to assert the rights of
women for whom the Plan B prescription requirement is a barrier to their ability to use the drug in a timely and
effective manner. (See supra at 50). Consumers of drugs, however, are in no sense “applicants” for drug approval
under section 355 of Title 21; they have filed no application under section 355, and indeed could not. Accordingly,
they cannot invoke the special jurisdiction of the courts of appeals conferred by section 355(h).
18
Ordinarily, a court should avoid constitutional rulings if alternative grounds for decision are available. Jean v.
Nelson, 472 U.S. 846, 854 (1985). Here, however, two factors militate in favor of reaching Plaintiffs’ constitutional
claims. First, because the standard of review applicable to Plaintiffs’ constitutional claims is far less deferential than
the standard applicable to “arbitrary and capricious” claims (absent a finding of bad faith), adjudication of these
claims is much less dependent on matters of scientific evidence and judgment about which the Court may find that
genuine factual disputes exist. Second, given the Court’s repeated finding of agency bad faith, reaching Plaintiffs’
constitutional claims will serve to demonstrate the gravity of the FDA’s malfeasance, for it is rare that agency action
so blatantly violates fundamental constitutional rights.
61
As to all of Plaintiffs’ constitutional claims, the FDA’s actions are not entitled to any
deference. First, it is clear the Congressional intent in authorizing the federal courts to undertake
review of the constitutionality of agency actions via section 706(2(B)) of the APA was to
authorize plenary and de novo review of constitutionality. Webster v. Doe, 486 U.S. 592, 603
(1988) (“[W]here Congress intends to preclude judicial review of constitutional claims its intent
to do so must be clear. . . . We require this heightened showing in part to avoid the ‘serious
constitutional question’ that would arise if a federal statute were construed to deny a judicial
forum for a colorable constitutional claim.”) (citations omitted). Second, the FDA has no special
expertise that would entitle its findings on the constitutionality of the BTC scheme to any
deference. See Porter v. Califano, 592 F.2d 770, 781 (5th Cir. 1979) (finding no statutory reason
for courts to defer to agency findings in reviewing constitutional claims). Third, it is axiomatic
that only matters actually and properly considered by an agency are due any deference, and then
only if such matters are within the agency’s expertise. See Rydeen v. Quigg, 748 F. Supp. 900,
906 (D.D.C., 1990) (“When reviewing constitutional challenges to agency decisionmaking,
courts make an independent assessment of the facts and the law. . . . [W]e need not accord
deference to the agency’s decisions in regard to plaintiff’s constitutional challenges because the
courts, not agencies, are experts on constitutional issues.”) (citations omitted). Indeed, there is
no indication from the administrative record that the FDA itself even considered the
constitutionality of its actions regarding Plan B. Thus, even if it had considered the
constitutionality of its actions, such consideration would be due no deference because the FDA
has no expertise in constitutional law.
62
A. The BTC Regime Violates the Right to Decisional Privacy.
The right to obtain and use contraceptives has been protected as part of the fundamental
constitutional right to privacy beginning with Griswold v. Connecticut, 381 U.S. 479 (1965)
(right of married persons to use contraceptives), and continuing with Eisenstadt v. Baird, 405
U.S. 438 (1972) (right of unmarried persons to use contraceptives), and Carey (right of minors to
use contraceptives). A restriction on the sale or use of contraceptives affecting adults must be
justified by a compelling state interest. As the Court wrote in Carey:
Both types of regulation [of abortion and contraception] “may be justified only by
a ‘compelling state interest’ . . . and . . . must be narrowly drawn to express only
the legitimate state interests at stake.”
431 U.S. at 688 (quoting Roe v. Wade, 410 U.S. 113, 155 (1973)). Although the Court later
abandoned the “compelling state interest” standard for regulation of abortion, it has not done so
with respect to regulation of contraception, and indeed the reasons for changing the standard in
the abortion context are inapplicable in the contraception context. See Planned Parenthood v.
Casey, 505 U.S. 833, 871 (1992) (altering standard to accord greater importance to state interest
in potential life of the fetus); Carey, 431 U.S. at 694 (plurality) (“The State’s interests in
protection of the mental and physical health of the pregnant minor, and in protection of potential
life are clearly more implicated by the abortion decision than by the decision to use a
nonhazardous contraceptive.”); cf. Roe, 410 U.S. at 159 (“The pregnant woman cannot be
isolated in her privacy. She carries an embryo, and, later, a fetus, if one accepts the medical
definitions of the developing young in the human uterus. The situation is therefore inherently
different from marital intimacy, or bedroom possession of obscene material, or marriage, or
procreation, or education, with which Eisenstadt and Griswold . . . were respectively concerned.”
(citation omitted)). Thus, the Government in its initial motion to dismiss properly observed that
63
decisions of the United States Supreme Court “applied strict scrutiny to laws broadly restricting
access to contraception.” (Def.’s Mem. at 46.) The BTC regime is not narrowly drawn to serve
any compelling state interest and is therefore unconstitutional.
In addition, a restriction on the right of minors to use contraceptives must be justified by
a “‘significant state interest . . . that is not present in the case of an adult.’” Carey, 431 U.S. at
693 (quoting Planned Parenthood v. Danforth, 428 U.S. 52, 75 (1976)). As set forth in more
detail below, the BTC regime is not justified by any significant state interest, and certainly not
one “that is not present in the case of an adult,” and is therefore also unconstitutional because it
violates the rights of minors to use contraceptives.
Under Carey, even a government restriction on adults’ access to contraception short of a
“total ban” on contraception must be analyzed under strict scrutiny. Indeed, the Carey court
struck down a state law requirement much like the “point of sale” restriction of the BTC regime,
reasoning as follows:
Limiting the distribution of nonprescription contraceptives to licensed
pharmacists clearly imposes a significant burden on the right of the individuals to
use contraceptives if they choose to do so. The burden is, of course, not as great
as that under a total ban on distribution. Nevertheless, the restriction of
distribution channels to a small fraction of the total number of possible retail
outlets renders contraceptive devices considerably less accessible to the public,
reduces the opportunity for privacy of selection and purchase, and lessens the
possibility of price competition.
Id. at 689 (citations and footnotes omitted). It cannot genuinely be disputed that the BTC
regime’s restriction on the sale of Plan B to licensed pharmacists and health clinics likewise
imposes “a significant burden” on the right of adult women to use contraceptives. Not only do
Plaintiffs assert this in their own Declarations (DeMarco Decl. ¶ 6; Brown Decl. ¶ 9; Mahoney
Decl. ¶ 4), the administrative record is replete with recognition of this fact. See, e.g., Tummino
30755 (“Any system that creates barriers to access, including restricted distribution or age
64
restrictions would defeat the purpose of this drug and lessen its public health potential.”);
Tummino 30748 (“After Washington state reduced barriers to Plan B access, the data
demonstrates decreased pregnancies and abortions for adolescent age groups, and STD rates
national averages.”); Tummino 30648-51; 31026-30; 31031-32; 31095-99; Jenkins Dep. 114:7-
116:13. Indeed, in general the FDA recognizes that elimination of a prescription requirement
enables consumers to have easier access to a drug. Tummino 10080-81. Because the BTC
regime restricts adult women’s right to use contraceptives, it must be analyzed under strict
scrutiny. It fails this standard.
The only possible compelling interest the government could claim for the BTC regime is
protection of public health, and as to this interest, the government’s claim must be restricted to
the health of persons under the age of 18. There are several reasons that any asserted interest in
the health of minor women is not compelling.
First, where the division of scientific authority, both within and outside the FDA, is so
lopsidedly in favor of OTC access for women of all ages, the Court should find that scientific
authority simply does not support any age-based restriction on OTC access to Plan B. Surely the
scientific support for an age restriction cannot be “compelling” when every major public health
organization, all the internal usual decision makers at FDA, and one of the world’s leading
experts on Plan B all agree that the scientific justifications for the age restriction are spurious.
Moreover, to the extent that the reasons for the age restriction relate to speculation about how
OTC access to Plan B would affect the sexual and contraceptive behavior of young women, the
very fact that FDA does not consider the effects on personal behavior of drug approvals and
OTC switches renders this speculation far from compelling. See Rubin v. Coors Brewing Co.,
514 U.S. 476, 490 (1995) (“The Government’s brief submits anecdotal evidence and educated
65
guesses to suggest that . . . [the ban on listing alcohol content on beer labels] has constrained
strength wars that otherwise would burst out of control. These various tidbits, however, cannot
overcome the irrationality of the regulatory scheme and the weight of the record.”); Hodgson v.
Minnesota, 497 U.S. 417, 451 (1990) (finding that a two-parent notification requirement of a
minor’s abortion was “not merely ineffectual…but actually counterproductive” to achieving the
State’s goal of assisting and protecting minors in making reproductive choices). Importantly,
even this speculation is unsupported by the agency record, and, given Plaintiffs’ expert
declaration, should not be credited by the Court, because the speculation is false. Lastly, even
assuming arguendo the legitimacy of the FDA’s speculation about impact on personal sexual
behavior, any such speculative impact is equally present in the case of adults, and hence
unjustified even under the more lenient standard applicable to minors.
Second, even if the government could come forward with evidence supporting a
compelling interest advanced by the BTC regime, the BTC regime is not (at all) narrowly
tailored to serve such an interest.19 It uses the age of 18 as a cutoff even though the FDA’s entire
recalcitrant upper management endorsed the age of 17 as the appropriate age restriction. It
restricts the sale of Plan B to licensed pharmacists based on “state and private-sector
infrastructures” (Tummino 10866) for tobacco and pseudoephedrine products, even though
tobacco is extremely widely available, not, of course, sold only by pharmacists, and infinitely
19
In its letter acknowledging denial of the Citizen Petition, the FDA stated that one of the issues that would need to
be addressed by data regarding use of Plan B is the following: “Could sexually active girls under age 18 effectively
comprehend the labeling of the product and appropriately use Plan B both in terms of timing and selection, even in
the absence of parental or other adult involvement in the procurement and use of the drug?” (Cit. Pet. Denial Ltr. at
16 (footnote stating that age 17 was used as the cutoff instead of 18 omitted).) The implication that the FDA has any
role in assessing the value of parental involvement in contraceptive decisionmaking by adolescents simply confirms
that the FDA was acting in blatant disregard of constitutional rights of adolescents to use contraceptives, for
mandating parental involvement in contraceptive decisionmaking is unconstitutional. Planned Parenthood v.
Planned Parenthood Ass’n of Utah v. Matheson, 582 F. Supp. 1001 (D. Utah 1983); see also Carey, 431 U.S. at 694
(plurality opinion).
66
more dangerous than Plan B,20 and even though restrictions on pseudoephedrine were mandated
by Congress in light of widespread evidence of abuse whilst there is absolutely no evidence of
abuse of Plan B anywhere on Earth. Finally, allowing men 18 and over to buy Plan B without a
prescription, while simultaneously restricting the availability of Plan B so severely for women of
all ages, as the BTC regime does, is so hopelessly unrelated to any scientific evidence or other
possible justification that it renders the entire regime a travesty. Thus, far from being narrowly
tailored to serve legitimate interests, the BTC regime appears to be tailored to serve only the
irrational caprice of the FDA Commissioner and the White House which has directed the FDA’s
process regarding Plan B from the outset. See Rubin, 514 U.S. at 490-91 (finding the
government’s regulation of speech not sufficiently tailored to its stated goal).
Because the BTC regime burdens women’s right to use contraceptives without being
narrowly tailored to serve a compelling state interest, it is unconstitutional under the Due Process
Clause of the Fifth Amendment.
B. The BTC Regime Violates Equal Protection of the Law.
1. The BTC Regime Discriminates Based on Sex Without Serving an
“Exceedingly Persuasive Justification.”
The BTC regime affects access to a drug used exclusively by women, and which could be
needed by almost any woman at some point in her life. (Jordan Decl. ¶ 6.) The FDA’s action is
gender-based because the class of people who use Plan B consists of only women. Only women
are burdened by the FDA’s action; no men are burdened by it at all, because no men are potential
20
Since there are no deaths from Plan B, and hundreds of thousands from tobacco, we have the ratio:
.
0
000
,
100
∞
=
s
67
users of Plan B.21 See Saks v. Franklin Covey Co., 316 F.3d 337, 348 (2d Cir. 2003)
(distinguishing “cases involv[ing] a distinction based on the capacity to become pregnant and on
the exclusion of oral contraceptives, both of which disadvantage women only”) (emphasis
added). Thus, the Court should infer that the FDA’s action is gender-based. Indeed, federal
district courts have reached just this conclusion in the context of an employment discrimination
case under Title VII:
[T]he law is no longer blind to the fact that only women can get pregnant, bear
children, or use prescription contraception. The special or increased healthcare
needs associated with a woman’s unique sex-based characteristics must be met to
the same extent, and on the same terms, as other healthcare needs. Even if one
were to assume that Bartell’s prescription plan was not the result of intentional
discrimination, the exclusion of women-only benefits from a generally
comprehensive prescription plan is sex discrimination under Title VII.
Erickson v. Bartell Drug Co., 141 F. Supp. 2d 1266, 1271 (W.D. Wash. 2001). The same
reasonable inference should be made here: because the FDA’s action relates to a drug tied
directly, and solely, to the capacity of women to become pregnant, its action is gender-based.
Even if the BTC regime did not discriminate on its face based on sex, there is ample
evidence supporting a finding that, in adopting the BTC regime, the FDA acted with an intent to
discriminate on the basis of gender. First, the FDA’s action is rooted in gender-biased views
about the proper sexual conduct and reproductive decision-making of young adolescent women.
For example, Drs. Galson and Woodcock agreed that OTC status for Plan B might cause the
formation of “sex-based cults.” (Tummino 30745-46; Jenkins Dep. 67:20-68:3; 143:3-144:1.)
21
That the FDA’s treatment of Plan B is disadvantageous to women is obvious. Indeed, the BTC regime for Plan B
is unprecedented in its imposition by the FDA of point-of-sale restrictions on a nonprescription drug, and this
unprecedented regime comes across as especially invidious when compared to the numerous OTC products
available without age or point-of-sale restrictions that carry established adverse side effects as well as risks of abuse.
(See, e.g., Grimes Decl. ¶ 10(E); Woodcock Dep. at 155:11-19 (“Similarly, dextromethorphan, which is an
ingredient in over the counter cough and cold remedies is particularly used as a recreational drug in the 13 to 16-
year-old age group. And I, in my wildest dreams, could not imagine misusing cough and cold medicines, but these
young teenagers call them skittles, they use the internet to disseminate this sort of cult status of using, misusing this
drug.”); see also Tummino 31026.)
68
The entire opposition to unrestricted OTC status (reflected primarily in documents written by Dr.
Galson) is based on the view that young women will act irresponsibly and that special evidence
(of an unknown sort) is required to refute this view. (Tummino 30649-51, 30897-900, 30648-51,
31086, 31027; Jenkins Dep. 27:9-16; Rosebraugh Dep. 47:15-18; Woodcock Dep. 161:19-
163:13, April 27, 2006; Bull Dep. 50:18-52:9, June 21, 2006.) Such views impermissibly
“perpetuate the legal, social, and economic inferiority of women,” United States v. Virginia, 518
U.S. 515, 534 (1996), and are direct evidence of purpose to discriminate.
Second, the BTC regime’s authorization for men 18 and over to obtain Plan B without a
prescription in the absence of any evidence of safe or even possible use by men is compelling
evidence of sex discrimination because at the same time the FDA denied nonprescription access
to women under 18 for whom there was voluminous evidence of safe and proper use and indeed
of significant public health benefits. (Tummino 30648-51, 30745-83, 30784-828, 30881-91,
30897-900, 31026-28.) This feature of the BTC regime specifically promotes the stereotype that
all younger women are incapable of properly using Plan B without the benefit of a “learned
intermediary,” while every man 18 and over can serve as a “learned intermediary” for any
woman (or himself), regardless of age, to whom he transfers a purchased dose of Plan B. Adult
men as a class are, under the FDA’s BTC regime, fully capable of (1) using Plan B themselves
for some presumably experimental purpose; (2) knowing not to use Plan B and instead
transferring Plan B (possibly illegally) to any woman of any age for her use and guiding her as
her personal “learned intermediary” or ad hoc pharmacist, and as such: (3) inhibiting women
through their erudition from ever using Plan B “inappropriately”; and (4) single-handedly
preventing all the alleged harm to adolescent women that FDA upper management asserts might
befall them if they used Plan B without a physician’s guidance. Meanwhile, all women under 18
69
are deemed incapable of using Plan B safely without the guidance of a learned intermediary
despite clear-cut and overwhelming evidence that they can do so and that their sexual and
contraceptive behavior is not compromised. As Dr. Grimes testifies in his Declaration,
allegations to the contrary “are scientifically groundless and demeaning to women.” (Grimes
Decl. ¶ 10(D).)
Third, the FDA’s discriminatory purpose may be inferred from the foreseeable impact of
its action. E.g., Washington v. Davis, 426 U.S. 229, 241-42 (1976); Goldberg v. Whitman, 743
F. Supp. 943 (D. Conn. 1990). Here, the impact of the FDA’s action will be a diminution in the
ability of women to prevent unwanted pregnancies. (Tummino 30650, 31098.) Causing women
to become pregnant by denying them wider access to EC clearly perpetuates outmoded
stereotypes of women as childbearers, something government is barred from doing. J.E.B. v.
Alabama ex rel. T.B., 511 U.S. 127, 131 (1994). Because the BTC regime has no medical or
scientific basis, see infra Section IV D and see generally Grimes Decl., the Court should infer
that the intended purpose of the FDA’s action is to disadvantage women.
Impermissible purpose may also be inferred from departures from the normal procedural
sequence the agency followed. Village of Arlington Heights v. Metro. Housing Dev. Corp., 429
U.S. 252, 267 (1977) (“Departures from the normal procedural sequence also might afford
evidence that improper purposes are playing a role. Substantive departures too may be relevant,
particularly if the factors usually considered important by the decisionmaker strongly favor a
decision contrary to the one reached.”). These are extensive and occurred at nearly every step of
the FDA’s process. (See infra Section IV C; see also Jenkins Dep. 16:9-17:11, 33:8-17; Houn
Dep. 20:5-22:9, 30:7-31-15.) These departures from normal agency process are also strong
indications of invidious purpose.
70
In sum, the BTC regime is sex-based. As such, it must have an “exceedingly persuasive”
justification, and the burden of meeting this justification “rests entirely on the state.” Virginia,
518 U.S. at 532-33. As set forth below at 90-108, the overwhelming scientific evidence supports
unrestricted OTC status for Plan B. Accordingly, there can be no “exceedingly persuasive”
scientific justification for the BTC regime. Nor is the possible justification of deterring or
penalizing the sexual behavior of minors an “exceedingly persuasive justification,” for it is
doubtful that it is legitimate. See Carey, 431 U.S. at 695 (plurality opinion of Brennan, Stewart,
Marshall & Blackmun, JJ.) (expressing reluctance to attribute to state goal of inflicting
pregnancy and childbirth as “punishment for fornication”); id. at 715-16 (Stevens, J., concurring)
(rejecting such “government-mandated harm” as “a deprivation of liberty without due process of
law.”). If the government has some other justification for the FDA’s sex-based action, the
burden falls squarely on it to come forward with it.
2. The BTC Regime Discriminates Against the Exercise of the
Fundamental Right to Use Contraception.
The undisputed record before the Court demonstrates that Plan B has been treated
differently both from all other drugs recently considered for OTC status, and indeed from all
other drug applications to the FDA. Singling out a contraceptive drug for application of an
unprecedented standard discriminates on the basis of the fundamental right to contraception and
subjects the FDA’s actions to strict scrutiny. Mass. Bd. of Retirement v. Murgia, 427 U.S. 307,
312 (1976) (“equal protection analysis requires strict scrutiny of a legislative classification . . .
when the classification impermissibly interferes with the exercise of a fundamental right”);
Ramos v. Town of Vernon, 353 F.3d 171, 175 (2d Cir. 2003) (“A heightened level of review—
strict scrutiny—applies when [government action] . . . burdens a group’s exercise of a
71
fundamental right.”). As set forth above at 64-66, the BTC regime does not survive strict
scrutiny.
Evidence of the FDA’s singling out of Plan B for harsher review is legion. We describe
some of the more egregious examples. First, the FDA refused, as is its normal practice, to
extrapolate from evidence of safe use and label comprehension by adults to younger women.
(Jenkins Dep. 86:10-17, 94:17-95:21, 111:2-22, 118:13-119:9.) This normal practice is
reflected in the fact that during the past 10 years, the FDA has never required actual use or label
comprehension studies of adolescents in any OTC switch application, and has approved
numerous such switches. It is also reflected in the administrative record, which discloses that the
FDA informed Plan B’s manufacturer that such extrapolation was permissible. (Tummino
30100-02.) Second, the FDA required evidence that OTC status for Plan B would not change
adolescents’ sexual and contraceptive behavior; the FDA has not elsewhere considered effects on
personal behavior of drug approvals.22 Third, where the FDA in the past has not been confident
of the applicability of manufacturers’ studies in OTC switches to younger consumers, it has
always provided a label warning, rather than an age restriction, in approving such switches.
(Jenkins Dep. 91:11-19, 113:7-16, 118:13-119:9.) Fourth, the FDA has never in the past 10
years acted on an OTC switch against the recommendation of its Advisory Committees. (See 10
Year Rx Switch Chart, attached at Ex. E.) Fifth, no other OTC switch application has been made
at the level of the Director of CDER or higher. (GAO Rep. at 30.) Sixth, the White House has
not been involved in deliberations on any other OTC switch application. Seventh, FDA has
22
For example, in approving erectile dysfunction drugs, the FDA did not consider whether such drugs would have
an effect on sexual behavior. (Jenkins Dep. 125:18-126:11.) In approving drugs that treat lung cancer caused by
smoking, the FDA does not consider whether approval of such drugs will encourage smoking. In approving pain-
relief drugs for OTC use such as Tylenol and Advil, the FDA does not consider whether such approval will cause
people to engage in riskier pain-causing behavior. In approving various OTC drugs for acid indigestion, the FDA
does not consider whether such approval will cause risky over-eating behavior.
72
never imposed a point-of-sale restriction on any other OTC drug,23 even where there have been
subpopulations of the public for which specific OTC drugs pose special dangers, and even where
there is a demonstrated record of abuse of OTC drugs.24 Eighth, no other OTC switch
application was rejected prior to the completion of scientific reviews.
All of the above differential and harsher handling of Plan B establish that the FDA
applied a discriminatory standard to the Plan B OTC switch application. Such discriminatory
treatment of a drug which is the unique drug approved as a post-coital contraceptive triggers
strict scrutiny. Because, as demonstrated above at 65-66 the BTC regime is not narrowly
tailored to serve any compelling state interest, it violates the “fundamental rights” strand of equal
protection of the law.
C. The BTC Regime Violates Adult Women’s Right to Informational Privacy.
In order to obtain Plan B as an OTC drug, women 18 and over must present government
identification showing their age. (Tummino 10864-67.) This is not the case for any other OTC
drug product (except pseudoephedrine, which is subject to special federal legislation enforced by
the Drug Enforcement Agency because it has a demonstrated record of abuse in the manufacture
of illegal drugs, see http://www.fda.gov/cder/news/methamphetamine.htm). The FDA’s
requirement of disclosure of identifying information to pharmacies violates the right to
informational privacy, both because such disclosure itself is unjustified and because it provides
pharmacies with strong indicators that the woman seeking Plan B has experienced unprotected
sexual intercourse and needs Plan B to minimize the risk of pregnancy. (See generally Brown
Decl. ¶¶ 6-8; see also Grimes Decl. ¶ 12 (“the novel requirement to show a government
23
Indeed, the FDA does not even have authority to impose a point-of-sale restriction on Plan B or any other drug.
See Point V, infra.
24
A good example is dextromethorphan, which is available as an OTC drug without age restriction but has an
established record of abuse. (Tummino 31026.)
73
identification before provision of Plan B erases the potential for privacy of OTC provision”).)
The latter information is at the core of information as to which all citizens have a high
expectation of privacy. See Doe v. City of New York, 15 F.3d 264, 267 (2d Cir. 1994)
(“Extension of the right to confidentiality to personal medical information recognizes there are
few matters that are quite so personal as the status of one’s health, and few matters the
dissemination of which one would prefer to maintain greater control over.”); Bloch v. Ribar, 156
F.3d 673, 685 (6th Cir. 1998) (noting that publicly revealing information about sex exposes an
aspect of life we regard as highly personal and holding that rape victims have a right of privacy
in preventing gratuitous disclosure of the details of the rape); Eastwood v. Dept. of Corr., 846
F.2d 627, 631 (10th Cir. 1988) (“This constitutionally protected right [to privacy] is implicated
when an individual is forced to disclose information regarding personal sexual matters.”);
Thorne v. City of El Segundo, 726 F.2d 459, 468 (9th Cir. 1983) (the interest in keeping sexual
activity private is within the zone of privacy protected by the Constitution); United States v.
Westinghouse Elec. Corp., 638 F.2d 570, 577 (3d Cir. 1980) (“Information about one’s body and
state of health is a matter which the individual is ordinarily entitled to retain within the private
enclave where he may lead a private life.” (internal quotation marks and citations omitted)); In re
Labady, 326 F. Supp. 924, 927 (S.D.N.Y. 1971) (“[I]t is now established that official inquiry into
a person’s private sexual habits does violence to his constitutionally protected zone of privacy.”).
The right to informational privacy has been recognized at least since Whalen v. Roe, 429
U.S. 589, 599-600 (1977). Under the Second Circuit’s opinion in Doe, the government must
meet “[s]ome form of intermediate scrutiny,” in order to justify its mandated disclosure of highly
personal information. 15 F.3d at 269, citing Barry v. City of New York, 712 F.2d 1554, 1559 (2d
Cir. 1983). Specifically, the government must demonstrate a “substantial” interest in mandating
74
the disclosure. Doe, 15 F.3d at 269. As set forth above, the asserted justification for the
requirement — viz., concerns about OTC availability to women under 18 — is not “substantial,”
because it goes against the overwhelming weight of scientific evidence and indeed is so vague
that even scientists at the FDA did not know what evidence would convince FDA upper
management that the concern was invalid. Accordingly, the Court should find that the BTC
regime violates women’s right to informational privacy.
IV. The FDA’s Denial of Unrestricted OTC Status for Plan B is Arbitrary and
Capricious.
Under the APA, a reviewing court must set aside an agency action that is “arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5 U.S.C. §
706(2)(A); Tourus Records, Inc., v. Drug Enforcement Admin., 259 F.3d 731, 736 (D.C. Cir.
2001). When inquiring as to whether an agency decision was arbitrary or capricious, the
reviewing court “must consider whether the decision was based on a consideration of the
relevant factors and whether there has been a clear error of judgment.” Marsh v. Or. Natural
Res. Council, 490 U.S. 360, 378 (1989) (internal quotation and citation omitted). See generally
Henley, 77 F.3d at 620 (“An agency rule may be deemed arbitrary, capricious or an abuse of
discretion if the agency has relied on factors which Congress has not intended it to consider,
entirely failed to consider an important aspect of the problem, offered an explanation for its
decision that runs counter to the evidence before the agency, or is so implausible that it could not
be ascribed to a difference in view or the product of agency expertise.’”) (quoting Motor Vehicle
Mfrs. Assoc. of the United States, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)).
The inquiry must “be searching and careful,” although “the ultimate standard of review is a
narrow one.” Marsh, 490 U.S. at 378.
75
While a court’s task is to assess whether the agency’s determination is arbitrary,
“[a]gency deference has not come so far that [a court] will uphold regulations whenever it is
possible to conceive a basis for administrative action.” Bowen v. Am. Hosp. Ass’n, 476 U.S. 610,
626 (1986) (plurality opinion) (citing Motor Veh. Mfrs. Ass’n, 463 U.S. at 43) (internal
quotations omitted). Indeed, the “presumption of regularity afforded an agency in fulfilling its
statutory mandate is not equivalent to the minimum rationality a statute must bear in order to
withstand analysis under the Due Process Clause.” Id. at 626-27 (citing Motor Veh. Mfrs. Ass’n,
463 U.S. at 43) (internal quotations omitted). See also Paradyne Corp. v. United States, 647 F.
Supp. 1228, 1236 (D.D.C. 1986) (noting that the level of rationality required for an agency’s
action “must be greater than that necessary to extend analysis under the Due Process Clause of
the Constitution”). The “mere fact that there is some rational basis within the knowledge and
experience of the [regulators] . . . under which they might have concluded that the regulation was
necessary to discharge their statutorily authorized mission . . . will not suffice to validate agency
decision making.” Bowen, 476 U.S. at 627 (internal quotations and citations omitted). Thus,
absent a logical basis to support an agency decision, it must be held invalid. Additionally, an
agency rule is arbitrary and capricious if the agency “has relied on factors which Congress has
not intended it to consider.” Motor Veh. Mfrs. Ass’n, 463 U.S. 29 at 43. See also N.R.D.C. v.
Muszynski, 268 F.3d 91, 97 (2d Cir. 2001).
In assessing whether agency action is arbitrary and capricious, an important test is
whether the agency has adhered to its normal practice. “The dominant law clearly is that an
agency must follow its own precedents or explain why it departs from them.” Richard J. Pierce,
Administrative Law Treatise §11.5 (4th ed. 2002). Thus, the United States Supreme Court has
held that an agency has a “duty to explain its departure from prior norms.” Atchison, Topeka, &
76
Santa Fe Ry. Co. v. Wichita Bd. of Trade, 412 U.S. 800, 808 (1973) (plurality opinion). In
I.N.S. v. Yang, 519 U.S. 26 (1996), the Supreme Court elaborated on the consequences of
departing from agency norms, stating that “if [an agency] announces and follows—by rule or by
settled course of adjudication—a general policy by which its exercise of discretion will be
governed, an irrational departure from that policy (as opposed to an avowed alteration of it)
could constitute action that must be overturned as ‘arbitrary , capricious, [or] an abuse of
discretion” within the meaning of the Administrative Procedures Act.” Id. at 32.
Accordingly, it is axiomatic that an agency may not treat similar products differently
absent a rational basis. “Where an agency applies different standards to similarly situated
entities and fails to support this disparate treatment with a reasoned explanation and substantial
evidence in the record, its action is arbitrary and capricious and cannot be upheld.” Burlington
N. & Santa Fe Ry. Co. v. Surface Transp. Bd., 403 F.3d 771, 777 (D.C. Cir. 2005). As the court
in Bracco Diagnostics v. Shalala, 963 F. Supp. 20, 28 (D.C.D.C. 1997) put it, “the FDA is not
free to . . . treat [similar products] dissimilarly and to permit two sets of similar products to run
down two separate tracks, one more treacherous than the other, for no apparent reason.” Indeed,
“the disparate treatment of functionally indistinguishable products is the essence of the meaning
of arbitrary and capricious.” Id. (emphasis added). See also El Rio Santa Cruz Neighborhood
Health Ctr. v. Dep’t of Health & Human Servs., 300 F. Supp. 2d 32, 42 (D.C. Cir. 2004) (holding
that HHS’s inexplicable inconsistency is sufficient to allow the court to reverse its
determination). See also Indep. Petroleum Ass’n of Am. v. Babbitt, 92 F.3d 1248, 1260 (D.C.
Cir. 1996); Transactive Corp. v. United States, 91 F.3d 232, 237 (D.C. Cir. 1996).
Furthermore, where the FDA considers a factor or factors that it has not previously
considered when determining an application, and that are not articulated in its own review
77
regulations, its action may be found to be arbitrary and capricious. In Rhodia, Inc. v. F.D.A., 608
F.2d 1376 (D.C. Cir. 1979), the court decided an appeal from an FDA denial of Plaintiff’s
supplemental new animal drug application (NADA). The court found that the FDA improperly
considered whether changes in the supplemental NADA would increase available quantities of a
new animal drug on the market as a factor in determining drug safety. The court found that there
was “no indication that the FDA has previously considered changes in a NADA that will
increase available quantities of a new . . . drug to bear on the safety of the drug. Indeed, the
contrary appears to be the case.” Id. at 1379. The court noted that the FDA’s own regulations
“affirmatively exclude from the approval requirement . . . changes that appear to possess a
potential for increasing quantities on the market.” Id. The court vacated the FDA order denying
the supplemental NADA, stating:
[t]he FDA has the authority, and it has the responsibility, to define those changes
that bear on safety so as to invoke the full safety and effectiveness review
required by its supplemental NADA policy. Thus far, the FDA has not structured
its regulations to define quantity as a factor triggering invocation of the safety
review. Once it channels its discretion in a certain manner . . . the agency should
follow that course consistently or articulate reasons for departure. In view of its
previous course, bypassing quantity as a determinative criterion, the FDA may not
now latch onto this factor as the basis for rejecting an otherwise-unobjectionable
supplemental NADA.
Id. The Second Circuit in Nat’l Nutritional Foods Ass’n v. Mathews, 557 F.2d 325 (2d Cir.
1977), similarly held that where the Commissioner of the FDA made a determination of a drug
classification on the basis of factors that are not relevant to the statutory criteria, such a
determination is arbitrary and capricious. The court was clear to state that the determination that
an article is properly regulated as a drug “is not left to the Commissioner’s unbridled discretion.”
Id. at 334.
78
Under the governing law described, the FDA’s denial of OTC status for Plan B is
arbitrary and capricious.
A. This Court’s Repeated Findings that the FDA Engaged in “Improper
Behavior or Bad Faith” In Its Review of the Plan B Application Mandate a
Finding that the FDA’s Actions are Per Se Arbitrary and Capricious.
The Court should set aside the FDA’s decision to deny over-the-counter access to women
under 18 as arbitrary and capricious because the decision was made in bad faith. In reviewing an
administrative agency action, courts must judge the action on the actual basis of the agency’s
decision. See S.E.C. v. Chenery Corp., 332 U.S. 194, 196 (1947) (holding that “a reviewing
court, in dealing with a determination or judgment which an administrative agency alone is
authorized to make, must judge the propriety of such action solely by the grounds invoked by the
agency.”). If the agency’s underlying reason for acting was the product of bad faith, the decision
is rendered arbitrary and capricious because bad faith in the decision-making process denies the
petitioner the opportunity for their application to be given full and fair consideration. See
Latecoere Int’l, Inc. v. U.S. Dept. of Navy, 19 F.3d 1342, 1356 (11th Cir. 1994), citing Keco
Indus., Inc. v. United States, 492 F.2d 1200, 1203 (Ct. Cl. 1974) (“[P]roof of subjective bad
faith…depriving a bidder of fair and honest consideration of its proposal, generally constitutes
arbitrary and capricious action.”).
In this case, the FDA’s egregious treatment of the Plan B OTC-switch applications has
moved this Court repeatedly to remark that its actions “reek” of bad faith. (See Oct. 11, 2006
Hr’g Tr. 20; July 26, 2006 Hr’g Tr. 9:1; Dec. 22, 2005 Hr’g Tr. 95). After reviewing the
conclusions reached by the Government Accountability Office and evidence from the
administrative record demonstrating departures from the agency’s usual process for handling
OTC switch applications, the Court found that Plaintiffs had made a strong preliminary showing
79
of bad faith or improper agency behavior. See Tummino, 427 F. Supp. 2d at 231-32. This
conclusion was based in part on the Court’s concern that the FDA’s unreasonable delay in
issuing its original non-approvable letter to Barr was a “calculated ‘filibuster’ to avoid making a
decision subject to judicial review.” Id. at 231. The Court also indicated that it viewed the June
9, 2006, letter announcing the FDA’s denial of the Citizen Petition as showing bad faith (July 26,
2006 Hr’g Tr. 30:23-33:8; 36:18-24), no doubt in part because the letter is written as a litigation
document and designed as an attempt to defeat the Court’s jurisdiction.
In addition to unreasonable delay, the Magistrate Judge found at least five other
indications of bad faith on the part of the FDA:
1) Involvement in the Plan B OTC-approval process by high-level FDA officials
who, historically and statutorily, do not generally participate in OTC-switch
proceedings;
2) Inappropriate (non-scientific) considerations by FDA officials imported into
the Plan B OTC-switch process, including those brought to the FDA’s attention
by third parties;
3) Indications of efforts to chart an unusual course in dealing with the OTC-
switch applications, including veiled attempts to delay reaching a final decision;
4) Indications that a decision had already been made or that efforts were made to
steer the application towards a specific result under the direction of higher level
officials before completion of the scientific process;
5) Indications of potential retaliation by upper management against FDA
employees who disagree with management’s views that Plan B OTC-access be
restricted.
80
November 6, 2006 Magistrate Judge Decision and Order at 18. We show below that the record
contains more than mere indications of each of these indicia of bad faith by the agency but
abundant evidence that leads inescapably to the conclusion that the FDA’s decision-making
process was contaminated by each of those improper characteristics.
The FDA’s final decision to deny OTC access to women under 18 is marked by bad faith
for several additional reasons. First, von Eschenbach testified at his August 1, 2006,
confirmation hearing that his decision to make Plan B available without a prescription to women
18 and over was based on Dr. Galson’s finding that data regarding use of Plan B by women
under 18 was inadequate. Yet Dr. Galson, in his August 26, 2005, memo, stated that there was
adequate data to support OTC access to Plan B for women 17 and over, and that his support for
the age 18 cutoff was in turn based on von Eschenbach’s (non-scientific) reasons for choosing
18. Thus, von Eschenbach’s statement that his decision was based on a lack of adequate data for
use of Plan B by women under age 18 is belied by Dr. Galson’s findings to the contrary, made
public a year prior. The shell game played by von Eschenbach and Galson in their effort to
justify the arbitrary age 18 cutoff is redolent of bad faith agency action. Second, while von
Eschenbach misleadingly claims to adopt the “infrastructure” of tobacco sales (Tummino 10866-
67) to justify limiting OTC Plan B sales to people over 18 (von Eschenbach’s arbitrary choice),
the Plan B BTC regime restricts the sale of Plan B far more stringently than tobacco products by
making it available only at pharmacies. This is ironic, given that tobacco products kill hundreds
of thousands of Americans each year, F.D.A. v. Brown & Williamson Tobacco, 529 U.S. 120,
127-28 (2000), and Plan B has no serious side effects whatsoever. (Houn Dep., 127:11-12, 134:
12-19.) Third, the FDA has approved the sale of Plan B without a prescription to men 18 and
older even though there is absolutely no approved male use for Plan B, and certainly no evidence
81
in the agency record supporting its safe and effective use as a nonprescription drug by men. By
contrast, Acting Commissioner von Eschenbach refuses to approve nonprescription status for any
women under 18 — including those who are 17 years of age whom his predecessor,
Commissioner Crawford, publicly stated could use Plan B safely as an OTC product.
In addition, the FDA has continued to act in bad faith throughout the course of this
litigation. Most notably, it has asserted the deliberative process privilege in order to block
discovery of documents that Magistrate Judge Pohorelsky upon in camera review determined to
include evidence of bad faith. The FDA selectively invoked the deliberative process privilege
even though it had waived that privilege by turning over numerous other documents revealing
agency deliberations and failed to object to two prior rulings by the Magistrate Judge permitting
Plaintiffs to explore agency process with FDA employees. The FDA’s selective withholding of
information based on that privilege, which violates the “fairness doctrine,” see In re von Bulow,
828 F.2d 94, 102 (2d Cir. 1987) (“From that has grown the rule that testimony as to part of a
privileged [attorney-client] communication, in fairness, requires production of the remainder.”),
was plainly an attempt to limit this Court’s review to those documents that show the FDA’s
deliberative process in a favorable light.
Proof that any one of those factors delineated above, and described below in more detail,
infected the FDA’s decision requires this Court to enter judgment reversing the agency action as
arbitrary and capricious. In combination, they demonstrate that the Plan B OTC decision was
not simply arbitrary and capricious but one that is the product of an agency determined to reach a
improper result. In light of its demonstrated pattern of improper and evasive bad faith action,
there is little likelihood that FDA will ever engage in fair consideration of OTC status for Plan B.
For that reason, the appropriate remedy is not only to vacate the decision as arbitrary and
82
capricious but also to enjoin enforcement of the BTC regime and direct the FDA to remove all
restrictions on OTC availability of Plan B.
B. The FDA Relied on Factors Congress Did Not Intend It to Consider.
In 1951, when Congress amended the Food, Drug, and Cosmetic Act by the Durham-
Humphrey amendment, Congress determined that the default status of drugs is over-the-counter
status. Since enactment of the Durham-Humphrey amendment, the FDA has reviewed numerous
OTC switch applications under it and under regulations and internal criteria. These agency
interpretations of the federal statute have, with the exception of Plan B, been applied uniformly.
Under them, in assessing OTC switch applications, the FDA considers drug toxicity and the
capacity of individuals to use a drug safely without the guidance of a prescribing health care
provider, including an individual’s ability to understand instructions for proper use. The
Durham-Humphrey amendment and the regulations interpreting it do not permit the agency to
consider political acceptability of an OTC switch or impact of an OTC switch on personal
behavior.25 In this case, the FDA affirmatively asserts that it considered impact on personal
behavior as a factor in its decision on Plan B, and the evidence shows that the political
acceptability of OTC status of Plan B, particularly for younger women who are now excluded
from OTC access by the BTC regime, has been considered as a controlling factor throughout the
25
In numerous depositions conducted in this case, the government has sought to elicit from FDA officials their own
interpretation of the statutory and regulatory phrase “other potentiality for harmful effect.” (See, e.g., Woodcock
Dep. 177:14-180:6.) Specifically, the government has sought to elicit testimony that this regulatory phrase includes
harmful effects on personal behavior. However, these FDA employees’ interpretations of the regulatory phrase are
entitled to no deference whatsoever, and are contradicted by more specific testimony from FDA drug regulators
stating that personal behavior has not, other than in the case of Plan B, ever been used as a factor in deciding an
OTC switch application, and should not be considered in the determination of an OTC switch application. (See, e.g.,
Jenkins Dep. 187:2-188:10.)
83
agency’s process.26 Because the FDA relied on two factors which Congress has not intended it
to consider, the agency’s action is arbitrary and capricious.
1. The FDA Impermissibly Considered Personal Behavior.
The FDA’s entire justification for its denial of unrestricted OTC status is that such status
for Plan B might have an impact on the personal behavior of younger women, which in the
FDA’s view, is not adequately refuted by scientific evidence.27 As set forth below at 92-96,
there is overwhelming evidence that OTC access to Plan B would cause no change in the sexual
and contraceptive behavior of women under 18. Even in the absence of such evidence, however,
the FDA’s consideration of the impact OTC access on personal behavior is unprecedented and
not authorized by the FDA’s regulatory framework. (Jenkins Dep. 105:5-106:22; Grimes Decl. ¶
10(D).) There is uncontroverted evidence that the FDA has never previously considered impact
on personal behavior in making an OTC determination. (Tummino 30757-58, 31098;
Rosebraugh Dep. 105:18-106:13; Jenkins Dep. 105:5-106:22.) The FDA has utterly failed to
explain why, in the case of Plan B, it has departed from that uniform practice. The departure is
particularly unwarranted because Plan B is among the safest, easiest-to-use drugs the FDA has
ever considered for OTC status. (Tummino 31086; Houn Dep. 120:18-121:15; Jenkins Dep.
101:5-22.) Indeed, consideration of impact on personal behavior has never been considered
26
The government made no effort in eliciting interpretations of the regulatory phrase “other potentiality for harmful
effect” to obtain testimony interpreting the harmful effect to include harmful political effects.
27
Thus, Dr. Jenkins testified:
I read [Dr. Galson’s] explanation about his concern about developmental differences in adolescents, and
as I thought through the consequences of those issues, I couldn’t see how they related to decisions about
appropriately using Plan B. They seemed to be more applicable to the question of making appropriate
decisions about engaging in sexual intercourse . . . . I didn’t see those as relevant for the ability of
adolescents to safely and effectively use Plan B without a doctor’s involvement. . . .
. . . [W]hat I’m trying to say again is that the data that we had available from the Application, I felt and
others felt, had adequately demonstrated that the adolescent age group could safely and effectively use
the product without a physician’s intervention in the over-the-counter setting.
(Jenkins Dep. 108:15-109:7, 111:2-8.)
84
when other contraceptive drugs were reviewed and approved for OTC use. (Tummino 30648-52;
31026-30; 31031-32; 31095-99; Jenkins Dep. 105:5-106:22, 125:18-126:11.) If there is anything
peculiar about Plan B that justifies consideration for the first time in the agency’s history of a
drug’s impact on personal behavior, it cannot be discerned from the administrative record.
Moreover, were impact on personal behavior a factor that Congress intended the FDA to
consider, even a cursory review of approved OTC switch applications shows the morass that the
FDA would enter if it made those assessments. For example, in approving OTC switches of
antacid medications, must the FDA consider impact on individuals’ eating behaviors? In
approving OTC switches of pain medications such as ibuprofen or naproxen, must the FDA
consider impact on pain inducing behavior? In approving OTC switches of vaginal anti-fungal
creams, must the FDA consider impact on personal sexual and hygiene behavior? (Jordan Decl.
¶ 20.) The possibility that Congress intended the FDA to consider these impacts on personal
behavior is so far-fetched, and indeed so offensive to the numerous personal liberties that protect
each of these behaviors, that the Court cannot attribute such an intent to Congress. See, e.g.,
Carey, 431 U.S. at 695.
2. The FDA Impermissibly Considered the Political Acceptability of the
Plan B OTC Switch Application.
The uncontroverted evidence shows that beginning very early in the FDA’s consideration
of Plan B, the FDA consulted with the White House and charted a course for Plan B designed to
appease the constituents of President Bush opposed to OTC availability. Indeed, one witness
testified that the view was and remains “fairly widespread” within CDER that “non-medical and
political views” factored into the FDA’s decision to reject unrestricted OTC status for Plan B.
(Houn Dep. 101:9-102:1; see also Kweder Dep. 58:13-19.) Thus, for example, the original
85
decision to issue a Not Approvable letter for the Plan B OTC application in May 2004 was made
in consultation with the White House and implemented by then Commissioner McClellan well
before scientific reviews of the application were complete.28 (Jenkins Dep. 17:6-11; 18:2-17;
20:7-10; Kweder Dep. 44:3-45:8; 46:2-8; 56:8-57:5). Further, testimony that high-ranking FDA
officials involved in denying unrestricted OTC status were concerned about their future at the
agency and about damage to their credibility (Jenkins Dep. 232:12-20; Wood Dep. 40:2-19.)
compels the inference that political rather than scientific factors played a predominant role in the
FDA’s handling of the Plan B application.29 Moreover, the agency’s asserted justification for
denial of unrestricted OTC status has throughout related to asserted concerns about OTC use of
Plan B by adolescents, the very same “justification” that was produced in collaboration with the
White House in late 2003 or early 2004. Finally, Commissioner McClellan’s stonewalling of the
Government Accountability Office investigation into the Plan B Not Approvable letter provides
another basis for inferring consideration of impermissible political factors. See supra n.3. In
sum, there is direct evidence and evidence from which the court may infer that political factors
which Congress did not intend for the agency to consider were considered during, and indeed
were determinative of, the Plan B application review process.30 (Oct. 11, 2006 Hr’g Tr. 25:2-25;
27:21-28:3.)
28
It is well-settled that the White House has no proper role in agency adjudicatory and quasi-adjudicatory decision-
making. Sierra Club v. Costle, 657 F.2d 298, 407 (D.C. Cir. 1981) (finding “no inherent executive power to control
the rights of individuals” concerning adjudicatory or quasi-adjudicatory proceedings.)
29
Indeed, Dr. Houn, former head of the office within CDER that deals with reproductive health drugs, who feared
retaliation from the FDA for her testimony in this case, (Houn Dep. at 230:18-231:1,) testified that she was told by
two other FDA officials that if CDER leadership decided to approve an Plan B as an OTC drug, the leadership that
was involved in such a decision “may not be able to stay on” at the FDA. Id. at 102:22.
30
The Bush administration is no stranger to improper political influence over the work of scientific agencies. See
Adam Clymer, U.S. Revises Sex Information, and a Fight Goes On, NEW YORK TIMES (Dec. 27, 2002) (change in
language on National Cancer Institute’s Web site to indicate a link between abortion and breast cancer on the basis
of “newer scientific information” failed to reference the largest and most reliable study to date that concluded
abortions had no effect on breast cancer); Andrew C. Revkin, NASA’s Goals Delete Mention of Home Planet, NEW
YORK TIMES (July 22, 2006) (deletion of the phrase “understand and protect our home planet” from NASA’s
mission statement without consulting NASA employees in advance alarmed NASA researchers); Michael Specter,
86
C. The FDA’s Numerous Departures From Its Own Policies For Deciding OTC
Switch Applications Render the Rejection of OTC Status for Plan B
Arbitrary and Capricious.
The FDA’s actions on the Plan B OTC switch application and the Citizen Petition depart
dramatically from agency practice and precedent. The lengthy list of departures establishes
beyond any serious dispute that the FDA’s rejection of unrestricted OTC status for Plan B was
arbitrary and capricious, in particular because none of the departures has ever actually been
justified for such a safe and easy-to-use drug with such far-reaching potential health benefits for
American women. While one or another of these departures in isolation might not rise to the
level of arbitrary and capricious action, taken together they provide a text book example of an
agency cavalierly setting aside its own well-established “prior norms.” Atchison, 412 U.S. at 808
(plurality opinion). Indeed, some of the departures – such as the FDA’s “consultation” with the
White House or its rejection of unrestricted OTC status before scientific reviews were complete
–standing alone render the FDA’s entire process regarding Plan B arbitrary and capricious:
• the Office of the Commissioner placed individuals on the Reproductive Health
Drugs Advisory Committee who were not well-published or of the stature
normally held by such appointees in order to bring ideological “balance” to the
Committee, namely a number of persons associated with the anti-abortion
movement. (Kweder Dep. 36:12-21; 37:8-10.)
• the Commissioner of the FDA, who contacted the White House about the Plan B
OTC switch application within days after it was filed, decided in consultation
with the White House that the OTC switch application could not be approved.
Political Science: The Bush Administration’s War on the Laboratory, The New Yorker (Mar. 13, 2006) (removal of
a fact sheet about condoms from the Centers of Disease Control website for one year and replacement with language
denigrating the effectiveness of condoms and promoting abstinence represented “the most horrific examples of
manipulating science” that one senior CDC official had ever seen).
87
The record before this Court contains no evidence that the FDA has ever
contacted the White House about any other OTC switch application. (McClellan
Dep. 131:15-132, 127:10-15, 128:11-19, 140:19-141:13; Kweder Dep. 56:8-
58:19.)
• the OTC switch application for Plan B represents the only example in at least the
last decade in which the FDA has acted against the recommendation of its
Advisory Committees voting in favor of the application. (GAO Rep. at 29.)
• the Plan B OTC switch application was decided in a manner directly contrary to
the ordinary process prescribed in the FDA’s own policy manuals, which delegate
authority to decide such applications to the level of Office Director within CDER.
(GAO Rep. at 17.)
• Plan B is the only OTC switch application in the last ten years which the FDA has
demanded additional data as to adolescents and indeed almost all other approved
OTC switch applications have been accompanied by no data on adolescents at all.
(Tummino 31098.)
• Plan B is the only OTC switch application that was decided at the level of the
CDER Director or higher within the memory of any of the FDA employees
deposed by plaintiffs. (GAO Rep. at 30; Galson Dep. 35:22-36:3, 36:14-19.)
• the Plan B OTC switch application resulted in a nearly year-long advanced notice
of proposed rulemaking process allegedly implemented because the FDA doubted
its authority to approve an age restriction on an OTC drug, and then abandoned in
part to expedite the confirmation of the President’s appointee as Commissioner.
(Jordan Decl. ¶ 24.)
88
• the FDA notified the United States Senate that it would take action on the Plan B
OTC switch application by a certain date (in part in order to secure the
confirmation of another Presidential appointee) and then failed to take any action
by that date. (Def.’s Ltr. Mot. To Chief Judge Korman, dated July 25, 2005 at 33
(Document 20).
• even assuming arguendo that the FDA did not have adequate data to support OTC
use by adolescents, Plan B is the only drug in which age restriction has been
imposed contrary to the agency’s longstanding practice of simply including an
age warning on an OTC drug label. (Jenkins Dep. 113:2-16; Tummino 31097.)
• Plan B is the only OTC application as to which the FDA based its decision on
adolescents’ cognitive development, see n.6 supra.
• Plan B is the only OTC drug whose sale is restricted to pharmacies and health
clinics. Von Eschenbach Promotes Behind-the-Counter Drug Class, The Pink
Sheet (Mar. 16, 2007) (attached hereto at Ex. E).
• Plan B is the only non-prescription drug for which the FDA requires an individual
to produce identification to purchase. (Tummino 10864-67; Grimes Decl. ¶ 12.)
• Plan B is the only drug whose conditions of sale have been justified even in part
by the manner in which states regulate tobacco products. (Jordan Decl. ¶ 12;
Grimes Decl. ¶ 13.)
• the FDA’s rejection of the Citizen Petition was clearly timed not to reflect the
crystallization of some scientific judgment, but instead to impede Plaintiffs’
discovery efforts and defeat Plaintiffs’ unreasonable delay claim. See 36, supra.
89
Perhaps the most dramatic arbitrary and capricious action regarding Plan B is that
Commissioner McClellan, in consultation with the White House, decided that the FDA would
reject unrestricted OTC status for Plan B and that this decision was made (1) before the scientific
reviews of the OTC switch application by FDA scientists was complete, (2) without consultation
with FDA scientists, and (3) shortly after the joint advisory committees overwhelmingly
recommended unrestricted OTC status at a meeting which the Commissioner did not attend.
This decision by Commissioner McClellan, which he asserted was based on “concerns” about
data about adolescent women, has remained to this day the justification for rejecting unrestricted
OTC status and for the FDA’s August 2006 BTC regime. Although various memoranda written
by Dr. Galson have sought to express these concerns in scientific jargon, career scientists at the
agency have stated that the concerns were so vaguely expressed and nonspecific that they viewed
the concerns as insurmountable by any amount of evidence or data. See, e.g., Tummino 30649-
51, 31027, 31086. In addition, in the more than three years since Commissioner McClellan
made his decision to reject unrestricted OTC status, no evidence supporting any legitimate
concerns about adolescents’ OTC access has ever been identified either by the Office of the
Commissioner or by CDER Director Galson.31 Moreover, the evidence establishes that Dr.
Galson’s irrational efforts to justify the Commissioner’s concerns were the product of his fear
that if he did not tow the Commissioner’s line, his position at the FDA would be in jeopardy.
An agency charged to make decisions on the basis of scientific evidence surely engages
in arbitrary and capricious action when, as here, it bases its decision on vague and nonscientific
31
The arbitrary and capricious nature of the FDA’s entire process regarding Plan B is dramatically compounded and
confirmed by the details of the August 2006 BTC regime in which the Commissioner of the FDA raised the
minimum age OTC access to 18 despite Dr. Galson’s own finding that as a scientific matter, women 17 and older
should have OTC access. Notably again, Dr. Galson played the same obsequious role that he played previously in
the process by endorsing this change in the age limit, this time without even attempting to provide a scientific
justification.
90
views that are the product of consultations between the head of the agency and the White House.
Indeed, if the FDA’s decision on OTC status for Plan B is not arbitrary and capricious then the
Commissioner of the FDA at the behest of the White House or on his own whim could reject any
new drug or OTC switch application for any reason simply by announcing that he has “concerns”
about the application. As we set forth in the next section, the record does not support any of the
Commissioner’s ostensible concerns about adolescents having access to Plan B without
prescription. That evidentiary lacuna confirms that extreme arbitrariness and caprice animated
the denial of unrestricted OTC status.
D. The FDA’s Justification for Denial of Unrestricted OTC Status for Plan B
Runs Counter to the Evidence Before It and Is So Implausible That It
Cannot Be Ascribed to a Difference in View or the Product of Agency
Expertise.
The FDA has produced written justifications for its denial of unrestricted OTC status for
Plan B in each of the three “phases” during which it took public action on Barr’s OTC switch
application, as well as in its denial of the Citizen Petition. The first phase culminated in the May
2005 Not Approvable letter denying unrestricted OTC status. The second phase culminated in
the August 2005 announcement denying unrestricted OTC status and announcing an advanced
notice of proposed rulemaking. The third phase culminated in the FDA’s denial again of
unrestricted OTC status and its promulgation of the BTC regime in August of 2006, preceded by
its litigation-driven letter in June of 2006 admitting that it had denied the Citizen Petition. The
“scientific” justifications are detailed in memoranda by CDER Director Dr. Steven Galson, the
only FDA employee to write detailed reviews of the Plan B OTC switch application who
opposed approval of the unrestricted OTC switch. (The non-scientific justifications for the BTC
regime are contained in memoranda by Commissioner von Eschenbach.)
91
As set forth below, two purportedly “scientific” concerns emerge from Dr. Galson’s
memoranda. First, he stated his speculation that unrestricted OTC status could have an impact
on the sexual and contraceptive behavior of adolescents. This concern is illegitimate because the
FDA is not authorized to regulate such behavior (for either adolescents or adults). See supra at
82-85. Even assuming arguendo that the FDA could within its mandate begin to regulate the
personal sexual behavior of American citizens via its drug approval decisions, every available
piece of scientific evidence contradicts Galson’s speculation about behavioral effects of
unrestricted OTC status of Plan B. See infra at 92-96.
Second, Dr. Galson expresses the concern that the data does not establish that Plan B will
be safely and appropriately used by adolescents under 17 as an OTC drug. But this concern is
based on his unwillingness to extrapolate from data for older age groups to younger adolescents,
a concern he in turn bases on adolescents’ diminished capacity to rein in impulsive behavior (see
Tummino 31218) and his analysis of the available evidence is in any event wrong.32
Third – and without any scientific justification – Galson and FDA Commissioner von
Eschenbach, in adopting the BTC regime, raised the age of safe OTC use from 17 to 18.
32
In any event, Dr. Galson has demonstrated through his slipshod assertions that he is not qualified to draw
conclusions about safe and appropriate use of Plan B in an OTC setting. For example, in seeking to distinguish Plan
B from other OTC drugs for which the FDA has not required special adolescent data, Galson claims as one “critical
fact” that Plan B has:
specific risks . . . which differ from most other OTC drug products. Plan B is a form of oral contraceptive
that is currently available Rx-only because of the serious side effects that may be associated with long-
term regular use. . . . Other non-contraceptive, OTC products, such as antacids, are indicated for uses that
are normally associated with risks much less serious than unprotected sexual intercourse, unwanted
pregnancy, and the risk of stroke. . . . More information are [sic] needed demonstrating whether OTC use
of Plan B by women under the age of 17 would . . . present serious health risks (e.g., stroke and blood
clots) from frequent use of a high-dose oral contraceptive.
(Tummino 31220.) In fact, Plan B, which is a progestin-only contraceptive, has no known risk of stroke, blood clot,
or other serious adverse effects. (Grimes Decl. ¶ 10(F)) (“Plan B carries no increased risk of any cardiovascular
disease.”); (Houn Dep. 121:1-15 ([W]ith respect to toxicity, there is no established cardiovascular risk with
progesterone. And this is also documented in the post-marketing review of over a million and a half uses of Plan B.
. . . In fact, during the vote [by the Advisory Committee on Plan B] . . . it was unanimous that there wasn’t a safety
concern.”) Dr. Galson’s confusion (purposeful or not) of Plan B with contraceptives containing estrogen (which do
carry such risks) is emblematic of his scientific acumen and integrity.
92
1. Galson’s Speculation About Impact on the Sexual and Contraceptive
Behavior of Adolescents is Refuted by the Available Evidence.
Even if Galson’s stated concerns about such an impact were within the legitimate
purview of the FDA, those concerns are amply refuted by the available scientific evidence. As
FDA scientist Dr. Rosebraugh wrote:
The data reviewed . . . is quite compelling to dispel any potential concerns
regarding adolescent use or changes in sexually behaviors associated with plan B
use. . . . In terms of OTC switch applications, this drug has more information
available to allow us to predict consumer behaviors than any drug the Division
has approved for switch in recent memory. If this is not enough data upon which
to base a decision, it is unclear what would constitute enough data or even if that
is an obtainable goal.
(Tummino 30755-57.) In addition, as Plaintiffs’ expert Dr. Grimes explains: “[A] Cochrane
systematic review of the world’s randomized controlled trials of advance provision of emergency
contraception demonstrated no increase in risky sexual behavior or undermining of ongoing
contraceptive use.” (Grimes Decl. ¶ 10(D).) 33
All the other reviewers that commented on this concern echoed the tenor of these
opinions. For example, Dr. Daniel Davis, Medical Officer in the Division of Reproductive and
Urologic Drug Products, wrote:
7.5.2 Adolescent Use Data
In addition to the AUS, data from 3 other randomized controlled studies that enrolled
adolescents was submitted by the Applicant with the original supplemental NDA (see
Table 6). These studies involved advance provision of ECPs (varying from 1 to 3 packs)
to a generally high-risk group of sexually active women age 14 to 24 yr. All subjects
were provided with similar minimal information about the indication and correct dosing
for ECPs. Subjects were then randomized to receive ECPs by either advance provision
(AP) or standard access ([SA], i.e., needed a prescription and had to go to a pharmacy or
clinic to obtain ECPs). Subjects were followed over a 6-12 month period (much longer
than in the AUS.)
33
Dr. Grimes explains that “Cochrane reviews are published, peer-reviewed syntheses of randomized controlled
trials and reflect the highest level of evidence concerning the safety and efficacy of medical interventions.” Id.
93
Medical Officer’s Comments
• The above studies greatly expand the number of adolescents for whom we have data
concerning the use of emergency contraception and its impact on “risky behavior.”
There were over 1,000 adolescents age ≤ 16 yr., and almost 2,000 age ≤ 17 yr. When
possible, this group of young adolescents (17 yr. and younger) was compared to the
older adolescents age 18-20 yr.
• The statewide DIAL EC Project in North Carolina mimicked an OTC setting in many
ways. Women did not have to go to a clinic or health care provider to get a
prescription; they had to self-determine that they needed emergency contraception,
make a phone call to the coordinating center, and then pick up the ECPs at a local
pharmacy or Planned Parenthood Clinic (PPC). As in the OTC setting, they had to
pay for the pills and more often chose to go to a local pharmacy than to a PPC.
More than 9,700 prescriptions were issued to the 7,756 participants over a 29-month
period . . .
. . . There is evidence to suggest that the OTC availability of emergency contraception
will not increase sexual activity among young adolescents. A randomized controlled trial
in the U.K. of a teacher led intervention in schools with 1,974 boys and 1,820 girls, all
14-15 yr. of age, demonstrated that education about emergency contraception did not
increase sexual activity among this group of young adolescents. The intervention
increased levels of knowledge about emergency contraception, but there were no
differences observed in sexual activity or in frequency of emergency contraception use at
a 6-month follow-up. (n29. Graham A, et al. Improving teenagers’ knowledge of EC:
cluster randomized controlled trial of a teacher led intervention. British J Medicine 18
May 2002;324;1179-84.)
(Davis, 3/25/04 Medical Officer’s Safety Review of Supplemental NDA, Tummino 30809-10.)
Dr. Rosebraugh (Deputy Director of the Division of OTC Dug Products) and Dr. Bull
(Director of the FDA Office that handled nonprescription drugs) reviewed several of the other
studies of Plan B in some detail, and reached the same conclusion:
Below is a table of behavioral studies similar to that reviewed with the Commissioner.
This table demonstrates that there is data available on over 1900 adolescents 17 years old
and younger.
In reviewing these studies, adolescent use and contraceptive behavioral trends were
similar to those in older age groups and had the same trends as those demonstrated in the
AUS study. In prior discussions, upper level management was concerned that the extent
that these studies can be used in decision making may be limited because these studies
included healthcare provider intervention (counseling) that was not available in the actual
use study and would not be available for an OTC drug. However, for the two behaviors
94
of interest, timing of dose and contraceptive behaviors, the AUS provides data that health
care provider intervention does not impact on timing of dose or contraceptive behaviors
beyond what the label provides by itself (data presented below). . . .
. . . In Table 3, the data from the AUS demonstrate that the frequency of sexual
intercourse during the study and contraception use were comparable between different
age groups except that the 14-17 year old age group tended to use more effective
contraception after receiving Plan B.
Previous health care provider intervention also does not appear to impact upon
contraceptive behaviors. If we compare behavioral changes with subjects that had prior
experience with Plan B to novice users as seen in table 4, we see similar percentages of
contraceptive behaviors between groups. This would again support that prior
intervention of a health care provider did not influence subsequent contraceptive
behaviors associated with the use of this product compared to no intervention of a health
care provider. . . .
. . . The Gold study demonstrates that advanced provision of ECP 1) does not increase
promiscuous sexual behavior in 15-17 y/o adolescents compared to current methods of
access, 2) is more likely to lead to use of the product earlier after unprotected sex, and 3)
is more likely to lead to use of the product after unprotected sex compared to current
methods of access. . . .
. . . This study had 476 females aged 15-17 y/o and 1,614 aged 18-24 y/o. At baseline,
the adolescents had similar prior emergency contraceptive use and frequency of
unprotected sex as the older group, but had fewer prior pregnancies, abortions and STDs.
This would be expected because the younger subjects would have been sexually active
for a shorter duration than the older group. At study end, the 15-17 y/o compared to the
18-20 y/o had no significant differences in emergency contraception use on study,
emergency contraception use a second time, unprotected sex, or STDs as seen in table 10.
The behavioral data comparing the adolescents in the advanced provision group (n=194)
compared to the pharmacy access group (n=189) revealed no differences in frequency of
sex/month, number of sex partners or failure to use a contraceptive method as listed in the
table 11. This suggests that ready access to a 3 month supply of emergency contraceptive
in the house (advanced provision) did not alter the sexual or contraceptive behaviors of
adolescents compared to pharmacy access. . . .
. . . Overall, the data from Washington State would speak against the concerns that access
to Plan B would increase promiscuity or that females may not be able to use the drug
correctly. Since the State introduced reduced barriers to Plan B access, the data
demonstrates decreased pregnancies and abortions for adolescent age groups, and STD
rates below national averages. In fact, the State has decreased their National STD
ranking over this time period for two common STDs. Also during the six plus years that
95
Plan B has had pharmacy availability, there have no reports from Washington State that
Plan B has led to an increase in promiscuity among teenagers. In regard to the possible
abuse of Plan B, it must also be remembered that Plan B does not have any significant
CNS effects and has a high rate of non-serious adverse events, such as nausea in over
23% of subjects and menstrual irregularities that would prohibit recreational use of this
drug. Finally, as noted earlier, in Washington State, health care provider (pharmacist)
input into women’s decisions regarding Plan B use is minimal and consists of initialing a
check list that highlights tabling concepts. This demonstrates that all ages of females
seem able to use this drug with minimal health provider intervention. . . .
. . . A summary of the data reviewed demonstrates that:
• The Actual Use study demonstrated that users not receiving previous health care
provider counseling had similar timing of dose and contraceptive behaviors compared
to those users having had received prior health care provider counseling.
• The Dial study demonstrated that females 18 y/o and younger used ECP for the same
reasons and had similar timing of medication and repeat use frequency as older
females.
• The Gold study demonstrated that 15-17 y/o had the same sexual and contraceptive
behaviors as older females. 15-17 y/o with advanced provision had the same sexual
behaviors as 15-17 y/o obtaining the medication from a clinic and the advanced
provision group started the medication 10 hours sooner on average.
• The Raines study demonstrated similar contraceptive behaviors between 15-17 y/o
compared to 18-24 y/o and similar sexual behaviors in adolescents obtaining
advanced provisions compared to adolescents using pharmacy access.
• The Washington State data demonstrated that since pharmacy access has been granted
to Plan B in 1997:
o Adolescents pregnancy rates have decreased
o Adolescent abortion rates have decreased
o The total number of adolescent abortions have decreased
o STD rates have remained below national averages
o The national ranking for Chlamydia has decreased from 31st to 35th
o The national ranking for gonorrhea has decreased from 39th to 40th
There is compelling data evidencing that Plan B fulfills regulatory requirements for OTC
marketing. An overwhelming majority of members comprising two advisory committees,
with 12 out of 13 NDAC members and 12 out of 15 ACRHD members, voted for full
OTC approval. There is a rich body of literature demonstrating appropriate and safe use
of Plan B under decreased restrictions to access conditions. This memorandum reaffirms
my previous recommendation that Plan B should be approval for OTC marketing without
restriction.
(Rosebraugh & Bull, 3/23/04 Division Director Memo-Addendum, Tummino 30748-59.)
96
Dr. Jenkins’ overall summary shows that Dr. Galson’s concerns were utterly unfounded,
and indeed were completely refuted by the studies he was unwilling to consider:
[I]n addition to the studies submitted by the sponsor, there exists a substantial
body of data from recently completed published and unpublished studies on
emergency contraception that have enrolled a substantial number of adolescent
women. While none of the studies directly mimic the OTC setting for access to
Plan B, I believe that these data are relevant and help to address whether
adolescents can use Plan B in the OTC setting. Taken together, these additional
studies do not support a concern that adolescent women are less able to
understand the label directions or less likely to appropriately use the product than
older women. Further, these studies found that increased access for adolescents to
emergency contraception did not result in inappropriate use of Plan B as a routine
form of contraception, an increase in the number of sexual partners, an increase in
the frequency of unprotected intercourse, or an increase in the frequency of
sexually transmitted diseases.
(Jenkins, Mem. 4/22/04, Tummino 30898.)
Because the evidence overwhelmingly refutes Galson’s concern about impact on
adolescent behavior, this basis for rejecting unrestricted OTC status is arbitrary and capricious
even if it is assumed to be a factor within the agency’s statutory mandate.
2. Galson’s Statements About Adolescent Impulsivity Have No Link to
Safe and Appropriate Use of Plan B as an OTC Product and Are
Refuted by the Scientific Evidence.
As demonstrated below, the findings of FDA scientific staff with actual expertise at the
FDA, see Grimes Decl. at ¶10(G) (Galson appears to lack relevant scientific expertise), reveal
that Dr. Galson’s justifications are arbitrary and capricious for several reasons. First, he provides
no scientific explanation for his unwillingness to extrapolate from available data from older age
groups to younger age groups, despite the fact that the FDA does this routinely and, in fact,
earlier told the manufacturer that such extrapolation was appropriate for Plan B as well.
(Tummino 30100, Jenkins Dep. 111:17-22, Tummino 30898.). Dr Galson’s generalized concern
about the capacity of adolescents to engage in mature decision making would of course be
applicable to any drug, including the many drugs which the FDA switched to OTC status without
97
any adolescent data. Moreover, there is no evidence that links reported deficiencies in
adolescent reasoning abilities to any inability to understand the extremely simple instructions for
using Plan B, nor does Dr. Galson cite such evidence. (See Jenkins Dep. 61-62, 63:11-19.)
Second, as Dr. Grimes observes, Dr. Galson’s concerns about lack of data both in May
2004 and later in the process simply confuse the validity of the statistical evidence with its
precision. (Grimes Decl. at ¶ 10(A-B).) This confusion is particularly arbitrary because of the
many OTC switch decisions approved by the FDA for which adolescent data had zero precision
because no such data was ever even submitted or requested.
Dr. Galson asserted that his decision to reject unrestricted OTC status for Plan B was
based on developmental differences between younger adolescents and older age groups, which in
turn led him to assert that more data for younger age groups was needed. For example, in the
May 2004 memorandum justifying his Not Approvable letter, he wrote:
In making decisions about pediatric use, it is often possible to extrapolate data
from one age group to another, based on knowledge of the similarity of the
condition. However, in this case, adolescence is known to be a time of rapid and
profound physical and emotional change. For example, during early adolescence
(10-13), this age group experiences the emergence of impulsive behavior without
the cognitive ability to understand the etiology of their behavior. During mid-
adolescence (14-16), youth begin to develop the capacity to think abstractly;
however, their ability to integrate their emerging cognitive skills into their real-
life experiences is immature and incomplete. The capacity to understand complex
concepts, which develops during middle adolescence, allows adolescents to
modulate their impulsive behavior (n2. Rudolph’s Pediatrics, 21st edition, Chapter
3.1, Growth and Development, Psychological Development During
Adolescence.).
(Tummino 30901-02.) He reiterated his speculation in his August 2005 memorandum:
Finally, with regard to the characteristics of a younger population in general,
extrapolation of the actual use and labeling comprehension data to this group
could be inappropriate because data in the pediatric literature on younger age
groups suggest potentially significant differences from older adolescents with
regard to cognitive abilities and risk taking behaviors. The less developed
cognitive abilities of women under age 17 could lead to inappropriate use of Plan
98
B and the potential for younger women engaging in risky sexual behavior,
behaviors which carry significant safety and efficacy concerns.
(Tummino 31218-19.)
But Dr. Galson never provides any explanation of the mechanism by which such
developmental differences would affect the ability of younger adolescents to use Plan B safely
and appropriately without a physician’s guidance, or why such differences would not also affect
their ability to use any of hundreds of other OTC drug products appropriately and safely.
Dr. Jenkins explained why Galson’s stated concern about adolescents’ cognitive ability is
irrelevant to the assessments about the safety and efficacy of their use of Plan B:
Dr. Galson has cited developmental differences between adolescents and older women in
support of his concern about extrapolation of findings from older to younger women. In
my opinion, the concerns Dr. Galson raises are more applicable to the ability of
adolescents to make reasoned decisions about engaging in sexual intercourse, not their
ability to understand how to use Plan B safely and effectively as an emergency
contraceptive should they engage in unprotected sexual intercourse. The Plan B regimen
in very simple (one tablet as soon as possible after unprotected intercourse and another
tablet 12 hours after the first) and in many ways easier to follow than many other OTC
products that are labeled for use by adolescents and younger children (e.g., some OTC
products require a decision about the proper dose to be taken based on age or weight,
require frequent repeat dosing, and contain multiple warnings and “Do not use if”
statements). Further, levonorgestrel, the active ingredient in Plan B, has a very high
margin of safety. This high margin of safety combined with the packaging, makes it very
unlikely that a serious adverse event would occur if an adolescent incorrectly dosed the
product.
(Tummino 31096-31098.)34 In the absence of an explanation of how risk-taking behavior would
interfere with adolescents’ capacity to use Plan B safely and appropriately, Galson’s refusal to
extrapolate from older age groups is patently arbitrary (or just another version of his
impermissible foray into regulation of personal behavior).
34
In fact, as Dr. Jenkins testified, “We did not see any evidence that their behavior or their ability to use the product
correctly and safely and effectively was different from the older age group, so bringing in the developmental
differences, I didn’t understand its relevance, because we had data in front of us that seemed to refute that those
developmental differences were consequential.” (Jenkins Dep. 111: 9-116.)
99
Even if the Government were for the first time now to offer some link between
adolescents’ purported risk-taking behavior and their capacity to use Plan B safely and
appropriately as an OTC drug, the scientific evidence demonstrates that those concerns are
entirely unfounded, because, as set forth below, adolescents of all ages have been repeatedly
shown to be capable of using Plan B correctly.
A. “Inadequate Data on Adolescents”
Dr. Galson erroneously asserted that there was a “lack of available data” for adolescents
16 and under. Specifically, in two of his memoranda he wrote:
• My decision is based on the lack of available data relevant to OTC use of the product
by adolescents younger than 14 and very limited data in the 14-16 age group.
Without data in the application on OTC use in this age group, and lacking confidence
that data from older adolescents can be confidently extrapolated to this age group, I
find the proposal to switch Plan B from Rx to OTC use—thus making it available to
very young adolescents—to be unsupported.
(Galson, 5/06/04 Memorandum Re: Plan B, Tummino 30901-02.)
In reviewing a proposed switch from Rx to OTC status, FDA assesses the actual use and
labeling comprehension studies submitted by the applicant to support the switch. As
described in my May 6, 2004 Not Approvable letter, the April 2003 supplement
contained very limited actual use data on women ages 14 and 15, and no actual use data
on women under age 14. Similarly, the label comprehension study also included few
women ages 16 and under (n=76) (n.4. Plan B, Label Comprehension Study, Table 9,
page 31.). Moreover, as described below, what little data were in the supplement raised
questions about whether the product can be used safely and effectively by younger
adolescents.
(Galson, 8/26/05 Memorandum Re: Plan B, Tummino 31216.)
The concern about limited adolescent data is scientifically unjustified. As Dr. Jenkins
wrote in January of 2005:
Dr. Galson is correct in noting that a relatively small number of subjects less than 16
years of age were included in the label comprehension and actual use studies conducted
by the sponsor. As I noted in my previous memorandum, given the setting in which these
100
studies were performed it is likely that the observed age distribution is reflective of the
age distribution of the population of women who will use Plan B if approved for non-
prescription marketing. Further, I believe that it is entirely reasonable to extrapolate the
findings from the older women in these trials to adolescents given well established
agency precedent for extrapolating data from studies in adults and older adolescents to
younger adolescents and the fact that there was no suggestion based on the data from the
sponsor’s studies that younger women were less able to use the product correctly in a
stimulated OTC setting than older women. There is no pharmacologic or safety issue for
the use of levonorgestrel at the dose found in Plan B in younger adolescents compared to
older women, and the approved prescription labeling for Plan B and other oral
contraceptives that contain levonorgestrel make no distinction based on age.
(Jenkins, 1/14/05 Mem. Re: Review of Resubmitted NDA for Rx to OTC Switch for Plan B,
Tummino 31096-97.)35
Plaintiffs’ expert Dr. Grimes renders a similar opinion about Dr. Galson’s justification:
Dr. Galson stated in his memorandum of August 25, 2005, that “what little data were in
the supplement raised questions about whether the product can be used safely and
effectively by younger adolescents.” This claim was false. The data on women aged 16
years and younger were less extensive than for older women, reflecting the typical ages
of those who use the product. However, the data for women aged 16 years and younger
demonstrated that they used the product as appropriately as older women did. Stated
alternatively, the data for women 16 years and younger were 1) valid, 2) consistent with
those of older women, and 3) less precise due to smaller numbers. To imply that less
statistical precision “raised questions” about study validity was incorrect and misleading.
No evidence suggested inappropriate or unsafe use.
(Grimes Decl. ¶ 10(B).
Moreover, Dr. Galson, as set forth below, improperly excluded from consideration other
studies with much larger numbers of adolescent subjects, some of which are reflected in the
following table:
35
In fact, the FDA’s office that reviews pediatric drugs found that the age breakdown for prescription use of Plan B
included less than 0.5% of persons 8-14 years of age, and a detailed breakdown by age shows that the percentage of
14-year olds ranged between 0.2% and 0.4% in the period 2002-June 2004. (Tummino 10947.) Thus, for example,
Barr’s Actual Use Study, which included would have matched the prescription use age breakdown if it had included
one (1) adolescents under aged 14. In fact, it included 22 adolescents 14-16 years of age, and of these exactly one
(1) was 14.
101
Table 16. Studies Assessing Patient Behavior in Response to Facilitated Access to Plan B
Study Age Range Total N Age
≤16 years ≤17 years ≥18 years
Actual Use 14-44 540 22 46 494
Dial EC 8-51 7756 613 1225 6531
Gold 15-20 301 115 187 114
Raine* 15-24 2090 254 476 1614
Jackson 14-? 370 15 21 349
Belzer 14-20 160 NA NA NA
Total 11,217 1019 1955 9012
*2004, unpublished study
(Griebel, 4/1/04 Deputy Division Dir. Summary Review of New Drug App., Tummino 30868;
see also Tummino 30867-77 (providing detailed analysis of “Adolescent OTC Access Issues”
including adequacy of numbers of adolescents included in studies, correct dosing, value of
learned intermediary, advisory committee reaction to age restriction, benefits to OTC access for
adolescents, and risks to adolescents).)
B. Label Comprehension Studies
Dr. Galson also offered as a reason for his decision his observation that younger
adolescents performed less well than older adolescents in the manufacturer’s label
comprehension studies. He asserted:
First, when compared to older adolescents (>17 years) and adults, early
adolescents (ages 12-16 years) were less likely to specifically comprehend Plan
B’s labeling instructions. In the label comprehension study (N=656), adolescents
(ages 12-16 years, n=76) did not understand certain key directions in the labeling.
For example, women ages 12-16 did not understand as often as women 17 years
and older that Plan B’s indication is to prevent pregnancy after unprotected sex
(86% for ages 12-16, 93% for ages 17-25, 95% for ages 26-50), that Plan B is not
for routine use (57% for ages 12-16, 67% for ages 17-25, 71% for ages 26-50),
that the first pill should be taken within 72 hours after intercourse (77% for ages
12-16, 86% for ages 17-25, 87% for ages 26-50), and that the second pill should
be taken 12 hours after the first pill (77% for ages 12-16, 90% for ages 17-25, and
82% for ages 26-50) (n5. Plan B, Label Comprehension Study, Table 9, page 31.).
102
(Galson, 8/26/05 Mem. Re: Plan B, Tummino 31216.)
That reasoning is invalid and in fact is a scientific abuse of the studies. The label
comprehension studies are designed to test the quality of the manufacturer’s proposed labeling,
not the ability of consumers to use the product properly. Moreover, as Dr. Rosebraugh made
clear, this selective use of irrelevant differences in the label comprehension study gave greater
than appropriate weight to the label comprehension study, because the actual use study (as
indicated by its name) provides much more valuable information:
By way of prioritizing the importance of this study in the review of this application, it is
important to consider that in applications that include both a label comprehension and
actual use study, the actual use of the product as determined in the Actual Use study is
the basis to decide whether a concept of use is adequately conveyed. As expressed in Dr.
Leonard-Segal’s secondary review, the purpose of the label comprehension study in this
application was to enable the sponsor to test if their label adequately relayed information
that would allow proper use of the product in the Actual Use study and if not, to allow the
sponsor to make changes in the label prior to initiating the Actual Use study. When label
concepts demonstrate poor results, it can be either because the label language is difficult
to comprehend, or because the question evaluating the concept is poorly constructed. . . .
. . . In regard to #1, #2 and #3 above, the actual use study (to be discussed next)
demonstrated that:
1) Routine contraception use and effective contraception use was not affected during the
study.
2) Over ninety percent of subjects in the actual use study demonstrated dosing within 72
hours.
3) Over ninety percent of subjects took the 2nd pill between 6-18 hours after the 1st pill.
4) There were not any important differences across age demographics.
Therefore, concepts in the label comprehension study were either scored at a high level,
or those concepts not scoring at the higher level had high levels of appropriate use during
the Actual Use study.
(Rosebraugh, 1/9/04 Division Dir. Mem., Tummino 30445-46)
Furthermore, detailed analysis of the label comprehension study shows that Galson
accorded special weight to certain data differences while he ignored other, more important data.
As Dr. Griebel wrote:
103
1.2.1 Young Age Group Performance.
The youngest age group had scores that were reportedly statistically significantly
different from other age groups on 3 study objectives. These statistical analyses were not
adjusted for multiple comparisons, however, and on one the youngest age group scored
significantly better (side effects objective). On another (doesn’t prevent HIV/AIDS), the
youngest group scored similar to the oldest age group, but lower than the 17-25 year olds.
In only one objective (#6), the youngest age group scored both lower than the other age
groups and less than 86%–the objective evaluating understanding of timing of the second
dose at 12 hours post the first. The youngest age group scored 77% on this compared to
90% in the 17-25 year olds and 82% in the 26-50 year olds. This objective was assessed
with a single question, a direct question that asked when a woman should take the second
tablet. The score for the overall population on this question was 86%. The literacy
analysis found 82% of the lower literate and 93% of the higher literate participants
answered the question correctly. The division reviewers believe the youngest age
group’s 77% correct score for the 12 hour dose interval is still acceptable, and as will be
discussed later in this review, the younger age group performed similarly to the older age
group in taking the second dose at 12 hours in the actual use study.
(Griebel, 4/1/04 Deputy Division Dir. Summary Review of New Drug App., Tummino 30833.)
In addition, adolescents’ score on the timing of the second dose of Plan B is almost
entirely meaningless given that, as Dr. Houn testified, taking the two doses less than 12 hours
apart does not affect Plan B’s effectiveness. (Houn Dep. 122:15-123:2; see also Jordan Decl. ¶ 3
(stating that studies have found that Plan B (or its equivalent) remains effective regardless of
whether the second pill is taken at the same time as the first pill, 12 hours after the first pill, or 24
hours after the first pill, and that timing of the second dose does not increase side affects or
create a health risk)). As Dr. Jenkins summarized: “The data I saw from the Actual Use Study
and the Label Comprehension Study did not suggest to me that there was any substantial
difference between the older women and the younger women, and I continue to hold that view.”
(Jenkins Dep. 95:16-22.)
104
C. Actual Use Studies
Dr. Galson also selectively exploited data from the manufacturer’s actual use study to
justify his rejection of OTC status:
[T]he data from the actual use study, which enrolled very few women under 17 years,
also raise concern about the safety of OTC Plan B for young women. For instance, they
show that adolescents under age 17 were less compliant with the 4 week follow-up period
specified in the study protocol when compared to the older women (ages ≥17 years).
Fifty-five percent of the subjects aged 14-16 had two or more follow-up contacts, while
89% of the older subjects (ages 17-44) had two or more follow-up contacts (n.6 Plan B,
Actual Use Study, Final Report Tables, Table 1.4c, page 16.). These differences in
follow-up undermine the ability of the actual use study to support safe use of OTC Plan B
in this age group (n.7 See also, page 23 of January 12, 2004 sNDA review by OTC
Division (Jin Chen).). Furthermore, of the 29 14-16 year olds enrolled, most of them
were 16 year olds (20 of 29 or 69%) (n.8 January 11, 2005 email from Joseph Carrado to
Tia Frazier.).
(Galson, 8/26/05 Mem. Re: Plan B, Tummino 31216)
But no other FDA scientist viewed the data in this skewed manner. For example, Dr.
Bull, the Director of Office of Drug Evaluation V, the Office within CDER that reviewed
nonprescription drugs wrote:
As to the findings of the actual use study, it is noted that the actual use data submitted is
consistent with prior Agency findings of acceptability for OTC switch determination.
Specific to Agency concerns on teenagers, the findings of the study did provide a
sufficient representation of subjects in the lower age groups of women of childbearing
potential who are sexually active. It is noted that incorrect use was lower among subjects
16 and younger (13.6%) than in those 17 years and older (26.4%). There was also a
higher percentage of subjects in this age group who changed to a more effective
contraception (28.6% vs. 10.5%). Although a difference was found in taking of the
protocol specified timing for the second dose (75.9% vs. 93%) there was no evidence that
the difference in timing of the second dose adversely impacted efficacy and the reduction
of the risk of pregnancy in the study population for this subgroup.
(Bull, 1/21/04 Office Dir. Mem. Re: NDA 21-045, Plan B (levonorgestrel) proposing Rx to OTC
switch, Tummino 30650-51.)
105
Other FDA reviewers described adolescents’ performance in the actual use studies in
nearly glowing terms. Dr. Leonard-Segal stated:
At the request of the agency. the sponsor submitted a reanalysis of data on
teenage use of Plan B from the Actual Use Study. The actual use data is
predictive that teenagers 14-17 years of age would use OTC Plan B no less
properly than those 18-44 years of age. This reanalysis lends further support to
my view that the application to switch Plan B from prescription to over-the-
counter marketing should be approved. Id. at 30691.
(Leonard-Segal, 3/5/04 Medical Review, Tummino 30691-92.)
Similarly, Dr. Davis found :
• There was excellent compliance with the labeled dosing regimen among subjects <
18 yr. of age. Compliance was at least as good as that in the subjects 18 yr. and
older.
(Davis, 3/25/04 Med. Officer’s Safety Review of Supplemental NDA, Tummino 30800. See also
Griebel, 4/1/04 Deputy Division Dir. Summary Review of New Drug App., Tummino 30840
(“2.4.1 Age Analysis: Subgroup analyses by age, educational level and previous experience with
EC did not reveal significant differences in correctness of dosing across subgroups.”); Houn
Dep. (143-46 – confidential).)
D. Other Studies
Dr. Galson also managed to reject all other studies and literature reviewed by his
subordinates:
• The additional studies cited in the Office of New Drugs reviews do not approximate
actual OTC use sufficiently to support approval. Although the studies are relevant,
none tests the hypothesis that typical adolescent consumers with no extra information
will use the product correctly. The studies are either not conducted in the general
population or they provide product education assistance beyond what adolescents
would receive in an OTC situation, where no contact with a health care professional
is expected. Likewise, the literature review submitted to address questions of
important potential behavioral changes associated with availability of an emergency
106
contraceptive (e.g., substitution of the product for routine and more effective
contraception, or increased medically risky sexual behavior) did not contain studies
that mimic what would be actual OTC availability.
(Galson, 5/6/04 Mem. Re: Review of NDA for Rx to Over the Counter Switch for Plan B,
Tummino 30901-02.) This sweeping rejection of numerous other studies in which Plan B was
made more readily available than by a physician’s prescription is utterly without scientific or
common-sense rationale, and appears to be designed simply so that Galson could delete from his
consideration the wealth of scientific evidence that actually refutes all his stated concerns about
adolescents.
Thus, several FDA scientists described the great value of these other studies:
Studies of Plan B Use in Adolescents
Other concerns are that there are insufficient numbers of adolescents that participated in
the actual use study (AUS) limiting any conclusions for this demographic. OTC switches
can be based on a variety of data including randomized trials or historic use of similar
products. It is important to remember that “actual use” is just a title indicating that the
study is used to analyze a product for OTC use. There are currently no study designs that
can exactly mimic the OTC setting. Other studies that aren’t titled “Actual use” can
contribute data in the determination of OTC appropriateness. For plan B, there exists a
large body of data supporting the actual use study including randomized clinical trials
evaluating a variety of distribution mechanisms for emergency contraceptive pills (ECP)
and a large study of women who accessed emergency contraception via telephone. These
data give more adolescent information on timing of dose, self-selection, repeat use,
diverse populations, clinic and non-clinic settings, behavioral changes over time and
follow-up over several months.
(Rosebraugh & Bull, 3/23/04 Division Dir. Memo-Addendum, Tummino 30748 (emphasis
added).)
Other scientists summarized the other studies in a similar manner, and with far greater
attention to actual analysis of the studies than Dr. Galson’s cursory rejection of them. Dr.
Griebel explained:
In summary, the actual use study is supported by large randomized controlled trials and a
sizeable single arm study that closely mimicked the OTC setting in terms of self-selection
107
and minimal interaction with an intermediary. These supportive studies enrolled large
numbers of adolescents, and showed no increase in unprotected intercourse. Impact on
contraceptive use varied. Jackson showed no change in condom use, Raine 2004 and
Gold 2004 showed an increase in condom users, while Raine 2000 showed a concomitant
decrease in condom users with an increase in oral contraceptive (OC) users. Changes in
OC use on the other studies also varied. It increased in the Raine 2004 study and
increased relative to the control arm in the Gold 2004 study. It remained stable on the
advanced provision arm of that study compared to the first month of the study, and was
also stable on the Jackson study. Pregnancy rates and STI acquisition were similar
between comparators in the studies that reported these endpoints. EC use was higher in
the advanced provision arms of these studies and repeat use was higher in the advanced
provision arms, but ranged from less than 10% to 15%. The Dial EC study showed a
similar rate of repeat use.
Data specific to adolescents less than age 18 were provided in exploratory analyses in 3
of the large studies. Raine 2004 data show that the unprotected sex patterns of the
adolescents echo those of the older age group on study and do not increase with advanced
provision of EC. Never [sic] use of condoms also showed a similar pattern between the
younger adolescents and those 18 and older in that study. Oral contraceptive use
demonstrated a greater increase in the adolescent group. Gold’s study also showed
similar patterns of unprotected intercourse between the older and younger age groups.
Condom use was highest in the youngest age group, while OC use was higher in the older
age group, with a similar pattern in comparisons to control arms. . . .
. . . The Divisions do not believe these data support concern for adolescent access. They
don’t show substitution for regular contraceptives and incorrect timing of use in those
studies that collected these data. The review divisions consider the data from the studies
discussed in this section relevant and supportive for evaluation of Plan B for distribution
in the over the counter setting. With the exception of the North Carolina DIAL EC study,
the randomized controlled trials evaluated advance provision of emergency
contraception. The Divisions believe that studies of advance provision are relevant to
assessing the behavioral impact of the facilitated availability of emergency contraception
through non-prescription distribution. Advance provision of EC is a form of access that
makes the product more available to a woman than even OTC access, since the product is
kept on hand at home for a woman to self-select when it is indicated for her. Given that
the product use with advance provision is remote from the time that it is dispensed, the
woman must rely on the package labeling and any written information provided to her to
guide use at the time that she decides to take it. Senior CDER management has argued
that the presence of an educational component in these studies, which varied amongst
trials, negates the applicability of these studies to assessing the behavioral impact of
improved access to EC. The Divisions disagree. They do not concur that the education
provided in these trials would significantly counteract the behaviors most feared to result
from easy access to an emergency contraceptive in a high risk adolescent population, a
well-described age group known for risk-taking and inconsistent use of contraception… .
108
(Griebel, 4/1/04 Deputy Division Dir. Summary Review of New Drug App., Tummino 30860-
61.)
Dr. Beitz agreed. She wrote:
Study Strengths
• Taken together, the sponsor’s Labeling Comprehension and Actual Use studies along
with the other behavioral studies described here represent a large experience on the
use of EC by women at high risk for pregnancy who have been observed in a variety
of clinical settings. Findings from behavioral studies that evaluated women who
obtained EC in advance of need, or women who had had a prior pregnancy are very
relevant to the OTC setting.
• Over a thousand adolescents aged ≤ 16 years have been evaluated, with over half
participating in the Dial EC Project in North Carolina. Results from this study are
very relevant to the OTC setting given that subject eligibility was not restricted, there
was no interaction with a healthcare provider at an office/clinic visit, and callers had
to pay for their prescriptions.
• Findings regarding the use of EC, frequency of unprotected sex, and frequency of
pregnancy and STDs are remarkably consistent across studies, clinical settings, and
age strata.
(Beitz, 4/2/04 Mem. Re: NDA 21-045 Levonorgestrel; Plan B Barr Research, Tummino 30888.)
3. The BTC Regime’s Age Cutoff Has No Scientific Justification.
The eleventh-hour shift of the age restriction to age 18 is arbitrary and capricious on its
face, being based on nothing more than the presumed incompetence of pharmacists to verify any
age other than 18. In rejecting unrestricted OTC status in favor of the BTC regime, Drs. Galson
and then Acting Commissioner von Eschenbach justified the agency’s action as follows:
In an August 26, 2005 memo written by Dr. Steven Galson, the Director of the Center for
Drug Evaluation and Research (CDER), CDER found that for women 17 and older the
existing Rx dispensing requirements for Plan B® are not necessary to protect the public
health and that an Rx-only to non-prescription switch for those consumers is authorized
under 21 U.S.C. 353(b)(3) and 21 CFR 310.200. CDER also determined, however, that
Barr had not established that Plan B® could be used safely and effectively by young
adolescents—girls 16 and younger—for emergency contraception without the
professional supervision of a practitioner licensed by law to administer the drug. As a
result of this scientific conclusion (with which I concur), Plan B® may not lawfully be
109
made available without a prescription to this group under section 503(b) of the Federal
Food, Drug, and Cosmetic Act.
In considering the difficulty of enforcing an age-based restriction on the availability of
this oral hormonal contraceptive, I have concluded that 18 (rather than 17) is the more
appropriate cutoff point to best promote and protect the public health. The state-
regulated pharmacies that will be dispensing Plan B® under Barr’s voluntary CARESM
program (as well as society as a whole) are more familiar with 18 as a cutoff age. I
understand that in all 50 states, 18 is the age of majority (i.e., the legal delineation
between minor and adult), and retail outlets, including pharmacies, are familiar with
using 18 as the age restriction for the sale of certain products. With regard to drug
products, for example, the legal age to purchase FDA approved non-prescription nicotine
replacement therapy products is 18. Moreover, I also understand that as a matter of state
law many products routinely sold by pharmacies, e.g., tobacco products and non-
prescription cough-cold products like pseudoephedrine, are restricted to consumers 18
and older.
(Tummino 10866.)
Thus, the agency has put forth not a shred of scientific or medical support for the age
restriction being raised to age 18. Moreover, given that distribution is restricted to pharmacists
and health care professionals at clinics – professionals who are responsible for understanding and
educating consumers and patients about highly complex dosing instructions, allergic reactions to
drugs, multiple drug interactions, drug contra-indications, all of which may have life-threatening
consequences – it is particularly insulting – not to mention absurd – to suggest that those
professionals would be incapable of discerning from government identification that a person is
17, as opposed to 18. In addition, restriction of point-of-sale to pharmacies also has no scientific
justification or plausible enforcement justification, because numerous products, including
tobacco, liquor, beer and lottery tickets, may not legally be sold to minors, and those age
restrictions are implemented by all business entities – even convenience stores – that sell such
products. Indeed, as set forth below, the FDA lacks statutory authority to restrict the distribution
of OTC products.
110
V. The FDA’s Rejection of Unrestricted OTC Status for Plan B and Its Promulgation
of the BTC Regime Exceed the FDA’s Statutory Mandate.
As this Court has written:
The APA authorizes reviewing courts “to hold unlawful and set aside agency action . . .
in excess of statutory . . . authority. . . .” 5 U.S.C. § 706(2). “It is ‘central to the real
meaning of “the rule of law,” [and] not particularly controversial’ that a federal agency
does not have the power to act unless Congress, by statute, has empowered it to do so.”
Transohio Sav. Bank v. Director, Office of Thrift Supervision, 967 F.2d 598, 621 (D.C.
Cir. 1992) (citations omitted); Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979).
Agency actions that do not fall within the scope of a statutory delegation of authority are
ultra vires and must be invalidated by reviewing courts. Id. See also SEC v. Sloan, 436
U.S. 103, 118-19 (1978); Civil Aeronautics Bd. v. Delta Air Lines, Inc., 367 U.S. 316,
334 (1961); 5 U.S.C. § § 701, 706(2)(C) (1988) (authorizing judicial review of agency
actions “in excess of statutory jurisdiction, authority, or limitations”).
Haitian Ctrs. Council, Inc. v. Sale, 823 F. Supp. 1028, 1047 (E.D.N.Y. 1993). The FDA’s
actions regarding Plan B exceed its statutory authority in two respects. First, as described above
at 83-84, the FDA’s statutory mandate does not include regulation of personal (including sexual)
behavior, and its reliance, even in part, on possible changes in the behavior of adolescents
stemming from easier access to Plan B, therefore exceeds that mandate. Second, the FDA’s
restriction on the sale of Plan B as a nonprescription product to pharmacies exceeds its statutory
authority because, as the agency itself has conceded, there is no provision in the Food, Drug and
Cosmetic Act for an intermediate class of drugs between OTC and prescription products.
First, the Food Drug and Cosmetics Act itself as well as the FDA’s regulations
implementing the FDCA contemplate only two categories of drugs: 1) non-prescription drugs
and 2) those drugs which are limited to dispensation upon a prescription. There is no statutory or
regulatory provision for limiting the sale of non-prescription drugs to particular business entities,
such as pharmacies.
111
Second, case law holds that “nowhere is FDA empowered to approve an NDA upon the
condition that the drug be distributed only through specified channels.” Am. Pharm. Assoc. v.
Weinberger, 377 F. Supp. 824, 829 n.9 (D.D.C. 1974), aff’d sub nom. Am. Pharm. Ass’n v.
Mathews, 530 F.2nd 1054 (D.C. Cir. 1976) (per curiam). In Weinberger, the District court
rejected an FDA regulation seeking to restrict “the distribution of methadone to certain specified
outlets as set forth in the regulation. In effect, it prohibits virtually all licensed pharmacies from
dispensing this drug when lawfully prescribed by a physician . . . .” 377 F. Supp. at 825.
Although Weinberger involved an attempt to restrict the distribution of a prescription drug,
rather than a non-prescription drug, its holding that the FDA lacks authority to regulate the
manner in which approved drugs are distributed applies with equal or greater force to the
distribution of nonprescription drugs. Indeed, more recent legislation by Congress confirms that
authority to regulate the distribution of nonprescription drugs that are deemed dangerous in some
manner does not lie with the FDA. Since Weinberger was decided, the FDA itself has stated
that, “The agency believes it is questionable whether the distribution of lawfully marketed OTC
drugs can be restricted [to a pharmacist-only class of drugs] under current statutory provisions.”
FDA Response to Citizen Petitions filed by American College of Apothecaries and the National
Association of Retail Druggists. FDA Docket No. 84P-0028/CP (Dec. 3, 1984) (attached hereto
at Ex. E). In fact, just two weeks ago, FDA Commissioner von Eschenbach was reported to say
that establishing a “behind-the-counter” class of drugs would require determining whether the
FDA has authority to create it. Von Eschenbach Promotes Behind-the-Counter Drug Class, The
Pink Sheet (Mar. 16, 2007) (Ex. E). Under Weinberger and the FDA’s own admissions of its
lack of authority to establish a new class of “behind the pharmacy counter” drugs, the BTC
regime exceeds the FDA’s statutory mandate. To paraphrase Haitian Ctrs. Council, the process
112
to which Plan B has “been subjected is ‘extra-statutory,’ and a ‘third thing’ nowhere authorized
by” Congress. Id. 823 F. Supp at 1047.36
36
Any argument by the FDA that Barr “voluntarily” accepted the BTC regime is belied by von Eschenbach’s letter
to Barr insisting that its revised application must limit access to pharmacies:
[W]e would like to learn more about your proposal to restrict distribution of Plan B® to certain
pharmacies, i.e., the OTC version of Plan B® would not be available at gas stations, convenience stores,
etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy
counter and (2) dispense the drug only upon the production of a valid photo identification card
establishing the age of the consumer. In particular, we would like to learn more about your plan to
routinely monitor these pharmacies to make sure they comply with the restricted distribution plan. In
addition, we are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails
to comply with them, e.g., whether the restrictions will be incorporated into the terms of a formal contract
and, if so, what the terms of that contract (particularly those terms related to a breach) look like. If after
our discussions we conclude that the CARESM Program isn’t sufficiently rigorous to prevent the OTC
version of Plan B® from being used by young girls who can’t safely use the product without the
supervision of a practitioner licensed by law to administer the drug, Plan B® will remain Rx-only for
women of all ages.
(Tummino 10864-65.)
113
CONCLUSION
For all the foregoing reasons, and in furtherance of restoring the scientific integrity of the
FDA’s drug evaluation process, this Court should enter judgment for Plaintiffs on each of the
causes of action pled in the Fifth Amended Complaint and order the FDA to approve Plan B as
an over-the-counter drug product without age or point-of-sale restriction.
Dated: March 31, 2007. Respectfully submitted,
/s Simon Heller
SIMON HELLER (SH-8760)
NAN E. STRAUSS (NS-3501)
VIVIEN LABATON (VL-1747)
SANFORD COHEN (SC-6601)
FRANKLIN ROMEO (FR-2194)
Center for Reproductive Rights
120 Wall Street, 14th Floor
New York, NY 10005
(917) 637-3600
ATTORNEYS FOR ALL PLAINTIFFS
ANDREA COSTELLO (AC-6197)*
Center for Constitutional Rights
666 Broadway, 7th Floor
New York, NY 10012
(212) 614-6464
ATTORNEY FOR PLAINTIFFS
TUMMINO, MAHONEY, GIARDINA,
MANGAN, SEGUIN, TINNEY, BROWN,
CHURCHILL AND HUNT
*Admitted pro hac vice
