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)