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FDA nominee stalled over “morning after” pill FDA nominee stalled over “morning after” pill

FDA nominee stalled over “morning after” pill

Drug NewsApr 13, 2005

A U.S. Senate Committee abruptly postponed a vote on President Bush’s nominee to head the Food and Drug Administration Wednesday, as leaders asked for more time to work out what has become a contentious fight over decisions made by the regulatory agency.

The Senate Health, Education, Labor and Pensions Committee was expected to easily approve the nomination of veterinarian Lester Crawford to head the FDA. Crawford is currently the acting commissioner, and as deputy has been running the agency for most of President Bush’s four years in office.

But last week, two committee members, Democrats Patty Murray of Washington and Hillary Rodham Clinton of New York, announced they would block a vote by the full Senate to officially give Crawford the job until the FDA announced a decision on whether to allow the so-called “morning after” birth control pill to be sold without a prescription.

Last spring the agency rejected the advice of two advisory committees and declined to let the pills be sold over-the-counter. That led to claims by backers of the drug that the decision was prompted by pressure from anti-abortion groups.

The drug’s maker, Barr Laboratories, submitted a revised application to allow it be sold without prescription only to those age 16 and over. The FDA was supposed to act on that application in January, but has not yet announced a decision. At his confirmation hearing last month, Crawford declined to say exactly when the FDA would rule, leading to Murray and Clinton’s announcement.

Health Committee Chairman, Republican Mike Enzi of Wyoming, and the panel’s senior Democrat, Edward Kennedy of Massachusetts, issued a joint statement after the committee meeting was postponed, saying that they hoped the extra time “will provide an opportunity for the Committee to come together and focus on maintaining the FDA as an agency free from politics and focused on protecting and promoting the public health.”

But speaking for himself, Kennedy added, “I hope that the Administration will take seriously the concerns raised in our committee.”

No new date has been announced for a committee vote, which must precede consideration by the full Senate.

Provided by ArmMed Media
Revision date: July 7, 2011
Last revised: by Andrew G. Epstein, M.D.

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