Wednesday, December 7, 2011

Plan B Availability Blocked by Sebelius

FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:

"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."

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