FDA to remove age restrictions on one-step emergency contraceptives

The Department of Justice said FDA will make Plan B One-Step levonorgestrel, a single-dose formulation emergency contraceptive from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), available OTC without any age restrictions but will maintain restrictions on two-pill versions. In a letter to Judge Edward Korman of the U.S. District Court for the Eastern District of New York, DoJ said it intends to withdraw its appeal of Korman's April order compelling FDA to make one-step emergency contraceptives available OTC without any age restrictions. DoJ said FDA will maintain age restrictions on the two-pill version of Plan B and its generic equivalents. The two-pill product is approved as a nonprescription drug for women age 17 and older, while younger women must have a prescription. According to DoJ, the sNDA submitted by Teva to allow for OTC sale of Plan B One-Step to those age 15 and over with proof of age "contained actual use data specifically addressing the ability of adolescents, including younger adolescents, to understand and follow the directions for safe and effective use as a nonprescription product" and that there are fewer data available on use of the two-pill version by younger adolescents. FDA approved the sNDA on April 30 (see BioCentury Extra, April 30).

DoJ said FDA asked Teva to "promptly" submit an sNDA with proposed labeling to make Plan B One-Step available OTC without age restrictions and that FDA would approve the sNDA "without delay." FDA said it will need to determine the scope of any exclusivity after approval of Teva's sNDA and that its decision could affect labeling approved for generic equivalents of Plan B One-Step. Earlier this month, the U.S. Court of Appeals for the Second Circuit denied DoJ's request for a stay of Korman's order for two-pill versions, requiring FDA to make them available OTC without any age restrictions. DoJ said its decision is in compliance with the court's order because Korman authorized FDA to comply by making Plan B One-Step and not the two-pill version available if the agency believed there to be a significant difference between the two (see BioCentury Extra, June 5). ...