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Tummino v. Hamburg

United States District Court, E.D. New York

May 10, 2013

ANNIE TUMMINO, et al., Plaintiffs, -
v.
- MARGARET HAMBURG, Commissioner of Food and Drugs, et al., Defendants

For Annie Tummino, in her individual capacity, as Vice-Chair of the Women's Liberation Birth Control Project as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Erin T. Mahoney, in her individual capacity, as Chair of the Women's Liberation Birth Control Project as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Carol Giardina, in her individual capacity, as Coordinator of the Women's Liberation Birth Control Project as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Kelly Mangan, in her individual capacity, as President of the University of Florida Campus Chapter of the National Organization for Women, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need, Stephanie Seguin, in her individual capacity, as Chair of the Florida National Organization for Women Young Feminist Task Force, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Lori Tinney, in her individual capacity, as President of the Gainesville Chapter of the National Organization for Women, as Coordinator of the Morning-After, Pill Conspiracy, and on behalf of women who need Emergency Contraception, Jennifer Brown, in her individual capacity, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Candace Churchill, in her individual capacity, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Francie Hunt, in her individual capacity, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of women who need Emergency Contraception, Plaintiffs: Andrea H Costello, LEAD ATTORNEY, Partnership for Civil Justice Fund, Washington, DC; Janet Crepps, LEAD ATTORNEY, PRO HAC VICE, Center for Reproductive Rights, New York, NY; Kirsten Clanton, PRO HAC VICE, Southern Legal Counsel, Inc., Gainsville, FL.

For Association of Reproductive Health Professionals, on its own behalf and on behalf of its members and women who need Emergency Contraception, National Latina Institute for Reproductive Health, on its own behalf and on behalf of women who need Emergency Contraception, Robert Jaffe, Aurora DeMarco, Angelica Jaffe, Catherine Lederer-Plaskett, Jonathan Marks, Gabrielle Marks, Plaintiffs: Janet Crepps, LEAD ATTORNEY, PRO HAC VICE, Center for Reproductive Rights, New York, NY; Andrea H Costello, Partnership for Civil Justice Fund, Washington, DC.

For Margaret Hamburg, in her official capacity as Commissioner of the Food and Drug Administration, Defendant: Farzin Franklin Amanat, LEAD ATTORNEY, United States Attorneys Office, Eastern District of New York, Brooklyn, NY; Eric B. Beckenhauer, U.S. Department of Justice, Civil Division, Federal Programs Branch, Washington, DC.

For Kathleen Sebelius, in her official capacity as Secretary of the Department of Health and Human Services, Defendant: Eric B. Beckenhauer, LEAD ATTORNEY, U.S. Department of Justice, Civil Division, Federal Programs Branch, Washington, DC; Farzin Franklin Amanat, LEAD ATTORNEY, United States Attorneys Office, Eastern District of New York, Brooklyn, NY.

For Teva Women's Health, Inc., Intervenor: Michael Shumsky, LEAD ATTORNEY, Kirkland & Ellis LLP, Washington, DC; Steven Menashi, PRO HAC VICE, Kirkland & Ellis LLP, New York, NY.

OPINION

Page 199

Edward R. Korman, Senior United States District Judge.

MEMORANDUM & ORDER

INTRODUCTION

I assume familiarity with the underlying facts and circumstances of this case that are detailed in my memorandum of April 5, 2013. Tummino v. Hamburg, __ F.Supp.2d __, 2013 WL 1348656 (E.D.N.Y. Apr. 5, 2013). Nevertheless, some introductory words are appropriate. This case involved Plan B and Plan B One-Step, emergency contraceptives that can be taken to reduce the risk of pregnancy after unprotected intercourse. They must, however, be taken as soon as possible after unprotected intercourse. The longer the delay, the less effective

Page 200

they become. The effort to convert these levonorgestrel-based contraceptives from prescription to over-the-counter status has gone on for over twelve years, even though they would be among the safest drugs available to children and adults on any drugstore shelf.

The FDA, responding to unjustified political interference, delayed as long as it possibly could before it took even one incremental step in the process. Ultimately, on December 7, 2011, in response to an application filed by Teva Women's Health (" Teva" ), the FDA concluded that Plan B One-Step--the one-pill version of the drug--could be sold over-the-counter and without a prescription or age restriction. The FDA was reversed by the Secretary of Health and Human Services on the same day in a decision that was politically motivated and that, even without regard to the Secretary's motives, was so unpersuasive as to call into question her good faith. Some five days later, the FDA rejected a Citizen Petition that sought unrestricted over-the-counter status for Plan B--the original two-pill emergency contraceptive product--and all drugs that are " equivalent" to Plan B. This decision was compelled by Secretary's reasoning in ordering the FDA to reject Teva's application. Specifically, the Secretary found that information that she deemed essential was not provided by Teva. The Citizen Petition lacked the same information. The Citizen Petition Denial Letter, which came five days after the denial of Teva's Plan B One-Step application, was clearly prompted by the Secretary's action despite the FDA's fanciful effort to make it appear that it undertook an independent review of the Citizen Petition. See Tummino v. Hamburg, 2013 WL 1348656 at *26.

On April 5, 2013, I issued an order directing the defendants--the Commissioner of Food and Drugs and the Secretary of Health and Human Services--to grant the Citizen Petition filed by the plaintiffs and make levonorgestrel-based emergency contraceptives available over-the-counter and without point-of-sale or age restrictions. I did so because the Secretary's action was politically motivated, scientifically unjustified, and contrary to agency precedent, and because it could not provide a basis to sustain the denial of the Citizen Petition.[1] I did not order the defendants to make Plan B One-Step--the widely known brand name emergency contraceptive--available. Teva had not appealed from the FDA's denial of its application, and, although it sought to intervene in this lawsuit, its intervention was not for the purpose of obtaining any relief related to its ability to market Plan B One-Step.

Plan B One-Step aside, the effect of my decision was to make levonorgestrel-based emergency contraceptives available without a prescription and without any point-of-sale or age restrictions. The only practical difference between my decision and the decision of the FDA that the Secretary reversed was that the FDA's decision was arguably directed towards the one-pill version of the drug, and my decision applied to both versions. Nevertheless, responding to far-fetched concerns ultimately voiced in response to the prospect of making the two-pill version available without a prescription, I advised the FDA that if it actually believed there was a significant difference between the one- and two-pill products, it was free to limit the relief on the Citizen Petition to the one-pill product. Tummino v. Hamburg, 2013 WL 1348656 at *31.

Page 201

With this concession to the FDA's concerns, my decision was entirely consistent with the initial decision of the FDA. I adopted and completely agreed with Commissioner Hamburg's conclusion that " there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential" --a conclusion that she reached after she had " reviewed and thoughtfully considered the data, clinical information, and analysis provided by" the FDA's Center for Drug Evaluation and Research. Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step (Dec. 7, 2011). Notwithstanding my deference to the Commissioner and the scientists at the FDA, the defendants have filed a notice of appeal and a motion to stay my decision as they continue their administrative agency filibuster through the appellate process.

I pause here before proceeding to a discussion of the merits of the motion to comment on the defendants' analysis of the manner in which drug approval applications should be made. Thus, they tell me that " [a] drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions. The agency alone has the necessary information and scientific expertise to assess the data and information required to make a determination that a drug is safe and effective." Defs.' Br. at 10. This salutary principle was flagrantly violated by Secretary Sebelius, who completely lacks the " necessary information and scientific expertise to assess the data and information required to make a determination that a drug is safe and effective," and whose role in the process has been circumscribed by Congress as well as by the delegation to the Commissioner of any authority that the Secretary may have--a clear recognition by Congress and the Secretary of her lack ...


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