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Wednesday, 7 December 2011

Plan B ruling: FDA overruled by Obama administration

The federal government Wednesday rejected a request to let young teenage girls buy the controversial morning-after pill Plan B directly off drugstore and supermarket shelves without a prescription. In a rare public split among federal health officials, the Health and Human Services Department overruled a decision by the Food and Drug Administration to make the drug available to anyone of any age without a restriction. In a statement, FDA Administrator Margaret A. Hamburg said she had decided the medication could be used safely by girls and women of all ages. But she added that Health and Human Services Secretary Kathleen Sebelius had rejected the move. “I agree ... there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child- bearing potential,” Hamburg said. “However, this 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,” she said.

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