Dec. 7, 2011 at 12:46 PM ET
Plan B One-Step, the so-called "morning after pill," won't be made available over the counter to girls younger than 17, regardless of a previous Food and Drug Administration recommendation, according to a statement by U.S. Department of Health & Human Services Secretary Kathleen Sebelius.
In a surprise move, Sebelius invoked her authority as the agency's head to overrule the recommendation of the FDA's Center for Drug Evaluation and Research -- and the conclusions drawn by FDA Commissioner Margaret Hamburg, according to statements issued today.
The move drewswift condemnation from ethicists and leading medical groups.
“In facing a tough call, HHS has put politics over science when it comes to sex,” said Art Caplan, director of the Center for Bioethics at the University of Pennsylvania and a frequent contributor to msnbc.com.
Dr. Robert Block, president of the American Academy of Pediatrics, called the decision "medically inexplicable," saying that it defies strong data that shows emergency contraception is safe and effective for girls and women of all ages.
But Sebelius said she wasn't convinced that Teva Pharmaceuticals Inc. had proven that non-prescription use of emergency contraceptives containing the drug levonorgestrel should be broadened. She expressed concern that girls reaching reproductive maturity at age 11 -- or even younger -- could have access to the medication.
"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," her statement said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."
Plan B One-Step is a single-dose pill that decreases the chance of pregnancy if taken within three days after unprotected sexual intercourse. It contains higher levels of a hormone found in some types of daily use birth control pills. It was originally approved in July 2009 for use without a prescription for girls and women older than 17 and with a prescription for those younger. Teva Women's Health Inc., the drug's maker, sought to broaden that use in an application submitted in February. Under that plan, it would have been available on store shelves.
Hamburg said she believed CDER's decision to approve wider use was both thoughtful and appropriate for all females of child-bearing age.
"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, 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," her statement said.
However, Sebeluis' decision trumps Hamburg's view, so the FDA sent a letter today telling Teva that the product would remain a prescription medication for girls and women older than 17, who must show ID to purchase the medication, and that younger girls would require prescriptions and consultation with health care providers.
Teva officials expressed surprise at the last-minute timing of Sebelius' decision.
"We commend the FDA for making the recommendation to approve providing women with increased over-the-counter access to Plan B One-Step and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," Teva spokeswoman Denise Bradley wrote in an e-mail.
The firm had not yet received the FDA's letter for review, Bradley said.
Msnbc.com health writer JoNel Aleccia and freelance health writer Rita Rubin contributed to this report.
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