Tummino v. Torti, 05-CV-366 (ERK)(VVP).

CourtUnited States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
Citation603 F.Supp.2d 519
Docket NumberNo. 05-CV-366 (ERK)(VVP).,05-CV-366 (ERK)(VVP).
PartiesAnnie TUMMINO et al., Plaintiffs, v. Frank M. TORTI,<SMALL><SUP>*</SUP></SMALL> Acting Commissioner of the Food and Drug Administration, Defendant.
Decision Date23 March 2009
603 F.Supp.2d 519
Annie TUMMINO et al., Plaintiffs,
Frank M. TORTI,* Acting Commissioner of the Food and Drug Administration, Defendant.
No. 05-CV-366 (ERK)(VVP).
United States District Court, E.D. New York.
March 23, 2009.

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Andrea H. Costello, Newberry, FL, Suzanne Ilene Novak, Janet Crepps, Sanford Cohen, Bonnie Scott Jones, New York, NY, Natalie N. Maxwell, Southern Legal Counsel, Inc., Gainesville, FL, for Plaintiffs.

F. Franklin Amanat, United States Attorneys Office, Eastern District of New York, Brooklyn, NY, for Defendant.


KORMAN, District Judge:

Plan B is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy after sexual intercourse. When used as directed, it can reduce the risk of pregnancy by up to 89 percent. Plan B acts mainly by stopping the release of an egg from an ovary. It may also prevent sperm from fertilizing an egg that has been released or, if fertilization has already occurred, block implantation of the resulting embryo in the uterus. Plan B does not have any known serious or long-term side effects, though it may have some mild and short-term side effects, such as nausea or abdominal pain, in some users. The approved dosage of Plan B is two pills taken 12 hours apart, each containing 0.75 mg of levonorgestrel, a synthetic hormone similar to the naturally occurring hormone progesterone. Because the drug works best when taken within 24 hours of sexual intercourse, it is commonly referred to as a "morning-after pill." Nevertheless, the drug is effective if the first dose is taken within 72 hours of sexual intercourse. Studies have shown that Plan B is equally effective if the two doses of levonorgestrel are taken less than 12 hours apart or at the same time.

Plan B was approved for prescription-only use in the United States in 1999 and is the only emergency contraceptive drug currently available in the United States. Plan B and other emergency contraceptives with the same active ingredient are available without a prescription or age restriction in much of the world, including virtually all major industrialized nations. Plaintiffs—individuals and organizations advocating wider distribution of and access to emergency contraceptives, as well as parents and their minor children seeking access to the same—brought this action challenging the denial of a Citizen Petition,

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which requested that the Food and Drug Administration ("FDA") make Plan B available without a prescription to women of all ages.

The FDA considered the Citizen Petition in tandem with a number of proposals—referred to as supplemental new drug applications ("SNDA")—submitted by Women's Capital Corporation, the drug's original manufacturer. Women's Capital Corporation sold its right to market Plan B to Barr Pharmaceuticals, Inc. during the course of the proceedings described below. I refer to them collectively as the "Plan B sponsor." The first SNDA, like the Citizen Petition, sought non-prescription access to Plan B for women of all ages. After the FDA denied such access, the Plan B sponsor submitted a second SNDA, seeking non-prescription access for women 16 and older. The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively. The Plan B sponsor then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older. While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of "enforcement" concerns, Plan B would be available without a prescription only to women 18 and older. Putting aside for the moment the specifics of the many claims brought by plaintiffs and the details of each of the FDA's decisions, the gravamen of plaintiffs' claims is that the FDA's decisions regarding Plan B—on the Citizen Petition and the SNDAs—were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.

Plaintiffs are right. The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays. The first occasion involved the confirmation of then-Acting FDA Commissioner Lester M. Crawford, who froze the review process for seven months in 2005. In order to overcome a hold that had been placed on his nomination by two Senators, the Secretary of Health and Human Services promised that the FDA would act on Plan B by September 2005. After Dr. Crawford was confirmed by the Senate in July 2005, however, he reneged on the promise and, instead, delayed action another eleven months to pursue, and then abandon, a rulemaking with respect to Plan B. There is also evidence that when the FDA finally decided to approve non-prescription use of Plan B for women 18 and older, it did so to facilitate the confirmation of Commissioner Crawford's successor, then-Acting FDA Commissioner Andrew C. von Eschenbach, whose confirmation certain Senators had vowed to block because of the continued delays on Plan B.

These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a "switch application" or an "over-the-counter switch." For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA's denial

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of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner—at the behest of political actors—decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.

In light of this evidence, the FDA's denial of the Citizen Petition is vacated and the matter is remanded to the FDA for reconsideration of whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions. While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the Citizen Petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription. Indeed, the record shows that FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription. The FDA's justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility.

I now proceed to outline the statutory and regulatory framework for the FDA's consideration of over-the-counter switch applications in general, detail the FDA's evaluations of and decisions regarding Plan B, and recount the procedural history of this action. I then turn to the merits of plaintiffs' claim that the FDA's denial of the Citizen Petition was arbitrary and capricious.

I. Background

A. Statutory and Regulatory Background

Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., no new drug product may be sold in the United States unless the Secretary of Health and Human Services ("Secretary") first approves a new drug application ("NDA") submitted by the drug's sponsor. Id. § 355. The Secretary delegated primary responsibility over drug regulation to the Commissioner of the FDA ("Commissioner"). Id. § 393(d). As part of the NDA, the drug sponsor must submit, inter alia, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use" to the FDA. Id. § 355(b)(1)(A). An NDA will be denied if "the investigations ... do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof," "the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions," or there is "insufficient information to determine whether such drug is safe for use under such conditions." Id. §§ 355(d)(1), (2), (4).

A drug must be dispensed by prescription if, "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 such drug." Id. § 353(b)(1)(A). A drug may be moved from prescription-only to non-prescription status when the Secretary deems that the prescription requirement is not necessary for the protection of the public health. Id. § 353(b)(3). Specifically, the applicable regulation provides that:

Any drug limited to prescription use ... 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

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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...

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