Tummino v. Hamburg

In 2011, the Federal Drug Administration (FDA) approved a drug application filed by Teva Women’s Health (Teva). The approval would have allowed Teva to sell Plan B One-Step, an emergency contraceptive, over-the-counter and without an age restriction. However, the FDA’s decision was reversed by the Department of Health and Human Services (HSS). The reversal was thought to be because of political influence. In response, a group of individuals, including Annie Tummino, seeking wider access to emergency contraceptives (plaintiffs) filed a citizen petition for reconsideration with the FDA. The FDA denied the petition, and the individuals pursued litigation against FDA Commissioner Margaret Hamburg (defendant). On April 5, 2013, the district court ordered the FDA to grant the citizen petition, which would make all levonorgestrel-based emergency contraceptives available without a prescription or age restrictions. However, on April 30, 2013, the FDA approved a revised application from Teva, which provided that only Teva’s Plan B One-Step product could be displayed on shelves, that the emergency contraceptives could be sold only at retail establishments with on-site pharmacies, and that any woman under 15 years of age would need a prescription. Following the court’s decision and the agreement reached with Teva, the FDA filed an appeal and a motion to stay pending appeal.