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From Health Law Daily, June 6, 2013

Second Circuit clears way for access to two-step emergency contraception for all women

By Paul Clark

The Court of Appeals for the Second Circuit has upheld a district court decision requiring the FDA to provide immediate over-the-counter access to the two-pill variants of levonorgestrel-based emergency contraceptives to all women of child-bearing age, pending appeal by the FDA (Tummino v Hamburg, June 5, 2013, Jackson, L). The appellate court, however, in the same order kept in place a restriction on one-pill emergency contraception. On May 13, the appellate court had granted the FDA’s request for a temporary stay on the district court order.

Background. In its April 5 decision, the district court reversed the FDA’s denial of a Citizen Petition originally filed in 2001 seeking to expand the availability of emergency contraception to women of all ages as an over-the-counter (OTC) drug and ordered the FDA to grant the petition and make emergency contraceptives available OTC without age or point of sale restriction. The court also noted there was considerable bad faith in the FDA’s 2011 decision to deny the Citizen’s Petition, along with intolerable delay in processing the decision, as the original petition was filed more than 12 years ago. In forbidding the FDA to engage in any rulemaking procedures or public comment prior to granting the petition, the court held “the plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by an exercise that permits the FDA to engage in further delay and obstruction.”

Stay on appeal. On May 13, the same district court ruled that HHS should not be granted a stay pending appeal. The court reiterated its finding that the Secretary’s action overruling the determination of the FDA that the pill could safely be sold to any woman of reproductive age without a prescription was politically motivated, without scientific basis, and inconsistent with the agency’s standard procedure. It also noted that the HHS did not suggest that there was a reasonable possibility that the finding would be overturned on appeal.

Nevertheless, as a courtesy to the Court of Appeals, the district court granted a stay until the appeals court could consider the government’s motion. The FDA filed its motion for a stay pending appeal on May 13, 2013.

In its June 5 ruling, the appellate court stated that the FDA’s appeal shall be heard on an expedited basis.

The case number is 13-1690.

Attorneys: Janet Crepps (Center for Reproductive Rights) for Association of Reproductive Health Professionals, National Latina Institute for Reproductive Health. Farzin Franklin Amanat, United States Attorney’s Office, for Margaret Hamburg, Commissioner, Food and Drug Administration. Eric B. Beckenhauer, United States Attorney’s Office, for Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services.

Companies: Association of Reproductive Health Professionals; National Latina Institute for Reproductive Health; Food and Drug Administration; United States Department of Health and Human Services

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