HHS overrules FDA on OTC Plan B use

HHS Secretary Kathleen Sebelius overruled an FDA recommendation and directed the agency to issue a complete response letter Wednesday for a label revision to make emergency contraceptive Plan B One-Step levonorgestrel available without a prescription to women of child-bearing potential 16 years and younger. The drug is approved for prescription-use only in the age group and for OTC use in women 17 and older.

In a letter to FDA Commissioner Margaret Hamburg, Sebelius said the label comprehension and actual-use studies submitted by Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) do not include data on all ages for which the drug would be approved and available without a prescription. ...