Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP)

CourtUnited States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
Writing for the CourtEdward R. Korman
PartiesANNIE TUMMINO, et al., Plaintiffs, v. MARGARET HAMBURG, Commissioner of Food and Drugs, et al. Defendants.
Docket NumberNo. 12-CV-763 (ERK)(VVP)
Decision Date04 April 2013

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

No. 12-CV-763 (ERK)(VVP)


DATED: April 4, 2013




Plan B and Plan B One-Step are emergency contraceptives that can be taken to reduce the risk of pregnancy after unprotected intercourse. In 1999, Plan B became the first emergency contraceptive drug approved for prescription-only use in the United States. In 2006, the Food and Drug Administration ("FDA") approved non-prescription access to Plan B for women 18 and older, and with a prescription to adolescents under the age of 18. Subsequently, the FDA was ordered to make it available without a prescription to adolescents aged 17. Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009). Even for women 17 and older, Plan B can only be purchased at a pharmacy and requires government-issued proof of age. Plan B One-Step was approved by the FDA in 2009 and is available without a prescription subject to the same restrictions. Though Plan B itself is no longer marketed, generic versions are available.

Both contraceptives contain the same total dose of levonorgestrel, a synthetic hormone similar to the naturally occurring hormone progesterone; Plan B consists of two pills containing 0.75 mg each of levonorgestrel that are to be taken 12 hours apart, while Plan B One-Step

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consists of one pill containing 1.5 mg of levonorgestrel. Studies have shown that combining the two 0.75 mg doses of the hormone into one pill does not decrease its effectiveness; indeed, the two Plan B pills may be taken simultaneously, fewer than 12 hours apart, or up to 24 hours apart, without any adverse consequences. Both Plan B and Plan B One-Step are most effective when taken immediately after intercourse and preferably no later than 24 hours later, though they may retain some effectiveness if taken within 72 hours. Neither drug has any known serious or long-term side effects, though they may have some mild short-term side effects, such as nausea, fatigue, and headache.

Levonorgestrel-based emergency contraception "interferes with prefertilization events. It reduces the number of sperm cells in the uterine cavity, immobilizes sperm, and impedes further passage of sperm cells into the uterine cavity. In addition, levonorgestrel has the capacity to delay or prevent ovulation from occurring." U.S. Gov't Accountability Office, GAO-06-109, Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual at 12 (November 2005), Case No. 05-cv-366, Doc. No. 68-2 (hereinafter "GAO Report").1 These contraceptives "have not been shown to cause a postfertilization event—a change in the uterus that could interfere with implantation of a fertilized egg." Id. at 13. Indeed, Diana Blithe, the biochemist who supervises research on contraception at the National Institutes of Health ("NIH"), opined that the possibility of levonorgestrel-based emergency contraceptives having an effect on implantation of fertilized eggs should "definitely" be taken off the labels for those drugs. Pam

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Belluck, Abortion Qualms on Morning-After Pill May Be Unfounded, N.Y. Times, June 6, 2012, at A1. Consistent with this position, the NIH removed statements regarding emergency contraception's possible effect on implantation from its website. Id. Nevertheless, because it would be "unethical and logistically difficult to conduct the necessary research" to conclusively establish that levonorgestrel-based contraceptives do not interfere with implantation, "the possibility of a postfertilization event cannot be ruled out." GAO Report at 13. Presumably for this reason, the FDA-approved label for Plan B and its generic equivalents still suggests, without affirmative evidence, that "Plan B may also work by preventing fertilization of an egg . . . or by preventing attachment (implantation) to the uterus (womb)."

Plaintiffs in this case—organizations and individuals concerned with women's health, as well as minors and their parents—seek to expand the availability of Plan B and all emergency contraceptives. This action was originally brought in January 2005 to challenge the FDA's denial of a Citizen Petition seeking over-the-counter ("OTC") access to Plan B for women of all ages. The complaint asserted that the FDA's denial of the Citizen Petition, which it considered along with a number of proposals regarding over-the-counter access to emergency contraception submitted by Plan B's sponsor,2 was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making. In a prior opinion, I concluded that the plaintiffs were right. Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009).3 In light of the overwhelming evidence of political pressure underlying the agency's actions, I vacated the

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FDA's denial of the Citizen Petition and remanded for the agency to exercise its discretion without impermissible political intrusion. I also directed the FDA to make Plan B available to 17-year-old women without a prescription, because the same evidence relied on by the agency to support over-the-counter access to the drug by 18-year-olds applied equally to 17-year-olds—a holding which the FDA ultimately conceded was "consistent with the scientific findings [the FDA] made in 2005." FDA Statement, Updated FDA Action on Plan B (levonorgestrel) Tablets (Apr. 22, 2009).

The plaintiffs argued that the ultimate relief they sought—over-the-counter access regardless of age—should have been granted without a remand because "the agency has acted so improperly and in such bad faith that it cannot be trusted to conduct a fair assessment of the scientific evidence." Pls.' Reply Mem. in Supp. of Mot. for Summ. J. at 9, Case No. 05-cv-366, Doc. No. 257. I rejected this argument, although I agreed with the plaintiffs that the FDA bowed to political pressure emanating from the White House and departed from agency policy. I declined to grant the relief plaintiffs requested for two principal reasons. First, the Commissioner of the FDA had resigned and his replacement, as well as a new Deputy Commissioner, had been nominated by the newly elected President. This change in leadership suggested that the FDA could be "trusted to conduct a fair assessment of the scientific evidence." Id. Second, it was my view that the decision whether to make Plan B available without a prescription regardless of age was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge.

The FDA did not rule on the remanded Citizen Petition for almost three years. During this time, the agency again considered a proposal—referred to as a supplemental new drug application ("SNDA")—from Plan B's manufacturer; this proposal would have allowed over-

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the-counter access to Plan B One-Step, the one-pill emergency contraceptive product, for all ages. The FDA agreed to approve this SNDA. FDA Commissioner Margaret Hamburg explained the process by which the FDA had reached its conclusion, with particular emphasis on the scientific evidence:

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence. The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process. Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step (Dec. 7, 2011), Case No. 05-cv-366, Doc. No. 339-2. Commissioner Hamburg then observed that she had "reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER," and she expressly agreed 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." Id.

Nevertheless, she explained that Kathleen Sebelius, the Secretary of Health and Human Services, "invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute...

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