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HHS overrules FDA, blocks over-the-counter Plan B for younger teens

December 07, 2011|By Melanie Mason
(HO/AFP/Getty Images )

The emergency contraceptive Plan B will not be made available over-the-counter to younger teens, the Food and Drug Administration announced Wednesday, exposing a rift between the agency and the Department of Health and Human Services.

Teva, the manufacturer of the oral contraceptive that can be taken up to 72 hours after sex to restrict ovulation or to potentially block the implantation of a fertilized egg, requested approval from the FDA in February to make the drug available without a prescription to individuals age 16 and younger.

Currently, the drug, commonly known as the "morning-after pill," is available without a prescription to women 17 and older, and is kept behind the pharmacy counter.

FDA commissioner Margaret Hamburg expressed support for expanding access for the drug without a prescription.

“I reviewed and thoughtfully considered the data, clinical information, and analysis provided by [the Center for Drug Evaluation and Research], and I agree with the center that 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,” FDA commissioner Margaret Hamburg said in a statement.

But Hamburg said she was informed this morning that HHS Secretary Kathleen Sebelius disagreed with the FDA’s determination, and therefore the request by Teva, Plan B’s manufacturer, will not be approved.

"[T]he switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately,” Sebelius said in a statement. "I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."

The drug will remain on the market, but women under the age of 17 must have a prescription.

melanie.mason@latimes.com

This post was updated to provide a clearer definition of how Plan B works.

Teva, the manufacturer of the oral contraceptive that can be taken up to 72 hours after sex to restrict ovulation or to potentially block the implantation of a fertilized egg, requested approval from the FDA in February to make the drug available without a prescription to individuals age 16 and younger.

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