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FDA plans decision on birth control

Sat., July 16, 2005

WASHINGTON – The Food and Drug Administration will decide by Sept. 1 whether a morning-after contraceptive pill can be sold without a doctor’s prescription.

The long-awaited deadline was unveiled in a letter sent by Michael Leavitt, secretary for the Department of Health and Human Services, to high-ranking senators. The news prompted two Democratic senators – Patty Murray of Washington and Hillary Rodham Clinton of New York – to announce Friday that they would allow a vote on the confirmation of Lester Crawford as commissioner of the Food and Drug Administration.

The two had placed a hold on the nomination because of the lack of a decision on the pill, which is also called Plan B.

“After more than two years of waiting, American consumers and American women will finally get an answer,” the two Democrats said.

An FDA advisory committee recommended in December 2003 that Plan B be approved for over-the-counter sales. The vote was 24-3.

Later, however, the FDA overruled that recommendation, citing concern about the pills’ use by young teenagers. Maker Barr Laboratories filed a second application to address those concerns; the agency still has not ruled.

Opponents of making the pill more readily available argue that such access could lead some young teens to have sex, leaving them more vulnerable to sexually transmitted diseases.

Supporters of making Plan B available over the counter said the drug would help women prevent unintended pregnancies and reduce the need for abortions, but to make a real difference, women need to be able to get it quickly.


 

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