Appeals court orders access to emergency contraceptives

An appeals court decision means FDA must make two-pill versions of emergency contraceptives containing levonorgestrel available OTC without any age restrictions, though one-pill versions will still be subject to age restrictions. The U.S. Court of Appeals for the Second Circuit granted a stay of an April order compelling FDA to make one-pill versions of emergency contraceptives available OTC without any age restrictions, which means FDA can uphold age restrictions on OTC sale of Plan B One-Step, a single-dose formulation emergency contraceptive from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA). That stay is in effect while the U.S. Department of Justice appeals the April order. The court denied DoJ's request for a stay for two-pill versions.

DoJ requested a stay and appealed the district court order in May, the day after FDA approved an sNDA to allow for OTC sale of Plan B One-Step to those age 15 and over with proof of age (see BioCentury Extra, May 10). ...