FDA’s Advice to Sell Plan B One-Step OTC Overruled

US Pharm. 2012;37(1):10.

Silver Spring, MD—The FDA’s recommendation that the age restriction on the emergency contraception pill Plan B One-Step be eliminated to allow it to be sold without a prescription to adolescents younger than 17 years was overruled by Health and Human Services Secretary Kathleen Sebelius. According to Sebelius, medical evidence from actual-use studies was insufficient to support the manufacturer’s (Teva Pharmaceuticals) application to make the drug available OTC to all girls of reproductive age. The FDA, however, maintained that the safety and efficacy of the drug for all females of childbearing potential were well supported by data from the two trials conducted by Teva. The drug remains available OTC to adolescents aged 17 and older.