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Controversy Over Emergency Contraception Drug

Senators Want FDA Decision on Selling Plan B Over the Counter
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WebMD Health News

April 8, 2005 -- The FDA has made slow progress as it considers a decision to allow an "emergency" contraception drug called Plan B to be sold over the counter. But things may speed up if two U.S. Senators have their way.

The senators say they will block confirmation of President Bush's nominee to head the FDA because of delays in an agency decision on the contraceptive.

Is It Science or Politics?

Sen. Patty Murray (D-Wash.) and Sen. Hillary Rodham Clinton (D-N.Y.) said Wednesday they had placed "holds" on the pending nomination of Lester B. Crawford until the agency renders a long-awaited decision on the drug. Senate rules give members the power to delay nominations or legislation for any reason.

Several groups have accused the FDA of moving too slowly in issuing a final decision on nonprescription sales of the controversial drug.

Plan B is typically taken within 72 hours of unprotected sex to prevent pregnancy. It works differently from RU-486, which is sometimes known as the "abortion pill". While RU-486 causes a woman to abort an established pregnancy, Plan B instead interrupts hormones and prevents a fertilized egg from implanting in the lining of the uterus.

"I absolutely do not believe it's science. I do believe it is politics within the administration that is holding this up," Murray tells WebMD.

Crawford is the FDA's acting director. The Senate Committee on Health, Labor, Education, and Pensions is due to vote on his nomination next Wednesday. But a hold will prevent the full Senate from voting on Crawford.

Murray says she will not lift her "hold" until the FDA issues a decision one way or the other.

Yes or No?

Plan B was first approved for prescription sales in 1999. Its manufacturer, Barr Laboratories, applied for over-the-counter status in April 2003. In December of that year an FDA advisory committee supported the application by a 24 to 3 vote.

But the FDA rejected the application, saying that Barr had not provided enough safety information for girls under 16. The company resubmitted the application with changes that would restrict nonprescription sales to patients 16 and over and require a prescription for those under 16.

The agency has not yet issued a decision on the application despite a regulatory deadline that passed in January, says Carol Cox, a Barr spokeswoman.

Some senators accuse the FDA of holding up the drug's approval because of political concerns in the Bush administration about abortion and premarital sex.

"The bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer, 'yes or no.' Science should never take a back seat to politics and ideology," Clinton says.

FDA officials did not respond to requests for comment Thursday. Murray says Crawford has given her no indication of when a decision on Plan B would be rendered. "He wouldn't say, and that's the problem," she says.

Cox declined to comment on the congressional debate. "We're just continuing to wait for a decision from the FDA," she says.

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