Administrative Law - Food and Drug Law - Eastern District of New York Rejects FDA Limitations on Plan B Emergency Contraception as Arbitrary and Capricious

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Plan B and Plan B One-Step are emergency contraceptives that a woman can take in the days following intercourse to reduce the risk of pregnancy. (1) Plan B was approved for U.S. prescription use in 1999; the similar but more advanced Plan B One-Step followed in 2009. (2) In December 2011, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius directed the Food and Drug Administration (FDA) to deny a Supplemental New Drug Application (SNDA) seeking approval for Plan B One-Step as an over-the-counter (OTC) drug without age restrictions. (3) The FDA complied with the directive. (4) Shortly after rejecting the SNDA for Plan B One-Step, the FDA also denied a citizen petition that had similarly sought OTC availability of Plan B for women of all ages. (5) Recently, in Tummino v. Hamburg, (6) Judge Korman of the Eastern District of New York ruled that the FDA's denial of the citizen petition was an arbitrary and capricious deviation from FDA policy. (7) One basis for this ruling was the Secretary's deviation from a convention of noninterference with the FDA drug approval process. (8) Although Judge Korman's ultimate conclusion may be adequately supported by the other bases he articulated, he should not have treated a deviation from mere convention as a deviation from formal policy.

In 1999, the FDA approved Plan B for prescription use only. (9) The Tummino plaintiffs (10) brought suit in 2005 challenging FDA denial of a citizen petition (11) seeking OTC access to Plan B regardless of age. (12) In 2006, the FDA approved the medication for OTC use in adults, but maintained the requirement of a prescription for adolescents seventeen and younger. (13) The plaintiffs continued to press their argument that the denial of the citizen petition was arbitrary and capricious, and that Plan B should be made available regardless of age. (14) Further, they argued that a remand was insufficient 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"; accordingly, they requested an order mandating OTC access. (15) In 2009, Judge Korman ruled that the denial of the citizen petition was arbitrary and capricious, but he concluded that remand was the appropriate remedy. (16) Although he suggested that the FDA's process had been impermissibly politicized and conducted in bad faith, (17) Judge Korman reasoned that the remand might be fruitful in light of President Obama's then-recent appointment of a new FDA Commissioner. (18) He therefore vacated the denial of the citizen petition and remanded the petition to the FDA. (19)

Shortly after the remand, the FDA approved Plan B One-Step subject to the same restrictions as Plan B: namely, it could be sold to adolescents sixteen and younger only with a prescription. (20) The manufacturer of Plan B then filed an SNDA that sought OTC access to Plan B One-Step for women of all ages. (21) In December 2011, the FDA, through Commissioner Margaret Hamburg, announced that it was prepared to approve the SNDA because the Center for Drug Evaluation and Research had determined that the benefits of nonprescription availability outweighed the risks. (22) However, HHS Secretary Sebelius, "invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions," ordered Commissioner Hamburg to deny the SNDA. (23) in her memorandum ordering the denial, Secretary Sebelius registered her concern about the "commonly understood" cognitive gulf between the youngest menarcheal girls and the class of females aged seventeen and over for whom the drug was already available OTC. (24)

Secretary Sebelius's directive was in one sense unprecedented: although Congress had explicitly vested responsibility for providing guidance to the FDA in the HHS Secretary, (25) an "unbroken practice of deference to the FDA" had previously governed HHS policy with regard to FDA rulemaking. …


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