Judge orders FDA to make Plan B OTC

A judge in the U.S. District Court for the Eastern District of New York ordered FDA on Friday to make emergency contraceptives available within 30 days "without a prescription and without point-of-sale or age restrictions." The ruling by Judge Edward Korman gives FDA discretion to limit the decision to one-dose levonorgestrel emergency contraceptives or to also include two-dose levonorgestrel products. The order overturns a 2011 decision by HHS Secretary Kathleen Sebelius overruling FDA's approval of unrestricted OTC sales of the emergency contraceptive Plan B One-Step levonorgestrel from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) (see BioCentury Extra, Dec. 7, 2011).

Former FDA Deputy Commissioner Mary Pendergast discussed Sebelius' decision to overrule FDA on BioCentury This Week last year (see BioCentury This Week, Jan. 1, 2012). ...