Friday, December 9, 2011

Morning-after pill should not be available to young girls over the counter, HHS secretary says, reversing FDA

Contrary to the recommendation of the U.S. Food and Drug Administration, girls younger than 17 won't be able to get the "morning-after pill" without a prescription. The FDA was overruled by Health and Human Services Secretary Kathleen Sebelius on Wednesday.

"Right now, girls age 17 and older can get the emergency contraceptive without a prescription, but a prescription is required for girls age 16 and younger," reports Darla Carter of The Courier-Journal.

Teva Women's Health requested that the drug, known officially as Plan B One-Step, be available to all girls of child-bearing age. FDA Commissioner Margaret Hamburg was in favor of the request, saying she felt there was "adequate, reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective."

But Sebelius disagreed and directed the FDA to write a letter denying Teva's request. "She cited insufficient data to support the company's application, plus cognitive differences between older adolescents and younger girls, such as 11-year-olds," Carter reports. (Read more)

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