The secretary of Health and Human services overruled a Food and Drug Administration recommendation Wednesday that would have emergency contraception without a prescription for girls younger than 17. Maker of Plan B One-Step had asked the FDA to make the pill available over the counter to all sexually active girls and women. Plan B is currently available over the counter for women 17 and older. Plan B prevents a fertilized egg from implanting in the uterus within 72 hours, though it is most effective in the first 24 hours. A prescription could delay that time.
FDA Commissioner Dr. Margaret Hamburg reviewed the relevant data, and made a statement that, “Plan B One Step is safe and effective and should be approved for non-prescription use for all females of child-bearing potential.” HHS Secretary Kathleen Sebelius overruled the recommendation, saying in a statement, “I do not believe enough data were presented to support the application … I have directed FDA to issue a complete response letter denying the supplemental new drug application.”
