FDA overruled: No to younger teens getting morning-after contraception without prescription

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WASHINGTON — In a sur­prise move, the Obama ad­ministration’s top health official overruled her own drug regulators and stopped the Plan B morning-after pill from moving onto drugstore shelves next to the condoms.

The decision by Health and Human Services Sec­retary Kathleen Sebelius means the Plan B One-Step emergency contraceptive will remain behind pharmacy counters, as it is sold today – available without a prescription to those 17 and older with ID.

The Food and Drug Ad­ministration was preparing to lift the age limit on Wednes­day and allow younger teens, who today must get a prescription, to buy it without restriction. That would have made Plan B the nation’s first over-the-counter emergency contraceptive, a pill that can prevent pregnancy if taken soon enough after unprotected sex.

But Sebelius intervened at the eleventh hour and over­ruled FDA, deciding that young girls shouldn’t be able to buy the pill on their own –
especially because some girls as young as 11 are physically capable of bearing children.

“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” she said. “I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age.”

It was believed to be the first time that the HHS has publicly overruled an FDA decision.

It was the latest twist in a nearly decadelong push for easier access to emergency contraception, and the development shocked women’s groups and maker Teva Pharmaceuticals, which had been gearing up for over-the-counter sales to begin by month’s end.

“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group. “There is no rationale for this move.”

But the decision pleased conservative critics of the proposal.

“Take the politics out of it, and it’s a decision that reflects the concerns that many parents in America have,” said Wendy Wright, an evangelical Christian activist who has helped lead the opposition to Plan B.

Major doctors’ groups and contraception advocates say quicker access to morning-after pills could cut the nation’s high number of unplanned pregnancies, but they have said they didn’t expect that selling Plan B over the counter would prompt much more use by younger girls. For one thing, the pill costs about $50.

They argued that putting the pill next to the condoms and spermicides would increase access for more sexually active ages who normally browse those aisles and would learn about emergency contraception. Teva planned ad campaigns aimed at 18- to 30-year-olds.

“I don’t think 11-year-olds go into Rite Aid and buy anything,” said Dr. Cora Breuner of the American Academy of Pediatrics. “We want it to be available to both girls and boys who have made a serious error in having unprotected sex and should be able to respond to that kind of lack of judgment in a way that is timely as opposed to having to suffer permanent consequences.”

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