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FDA Sets Deadline for Decision on Over-the-Counter Emergency Contraception

Secretary of Health and Human Services Michael Leavitt has promised that the Food and Drug Administration (FDA) will make its decision about the over-the-counter status of emergency contraception by September 1, 2005. Leavitt’s announcement comes after a series of delays on Barr Laboratories’ application for the sale of Plan B, a brand of emergency contraception, over-the-counter. At the expense of women’s health, the FDA has continued to put off making a decision despite two expert FDA advisory panels that voted 23 to 4 to recommend its availability in December 2003.

Last month, US Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) moved to force the FDA to make a decision by placing a hold on FDA nominee Lester Craword, preventing a floor vote on the nomination. After Leavitt’s announcement on Friday, Senators Murray and Clinton agreed to lift the hold. “After more than two years of waiting, American consumers and American women will finally get an answer,” said Senators Murray and Clinton in a joint statement. “While we continue to have concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA’s failure to provide an answer on Plan B.”

Sources:

Press Release, Office of US Senator Patty Murray 7/15/05; The New York Times 7/15/05; Feminist Daily News Wire 6/17/05; The Associated Press 7/15/05

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