FDA Comment Period on 'Morning-After Pill' Ends

By Marc Kaufman
Washington Post Staff Writer
Wednesday, November 2, 2005

A two-month comment period on making the "morning-after pill" Plan B available without a prescription ended yesterday, with as many as 10,000 comments apparently submitted but no indication of when or how the Food and Drug Administration will proceed with the controversial application.

The agency's next step "will depend on what we see in the comments," said FDA spokeswoman Julie Zawisza. "We'll read them all and decide how to proceed." She said 2,300 have been recorded so far, but a senior FDA official said he expects 10,000 when all are counted.

The agency's unusual handling of the Plan B application -- which is now going through its third FDA review -- has angered advocates of the emergency contraceptive. Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) said yesterday that they have helped collect 10,000 signatures on a petition calling on the FDA to act promptly on the Plan B application.

But social conservatives have applauded the latest review, which allows a different level of public involvement.

The Plan B application was overwhelmingly recommended by an agency advisory panel in December 2003 and was embraced by most of the agency's science staff. But top agency officials ruled against the application. Then-Commissioner Lester M. Crawford announced in August that the agency did not have the authority to approve the application because it contains a provision allowing women older than 18 to buy the contraceptive over the counter while younger girls would need a prescription.

Murray said yesterday that she was "stunned" by the agency's actions on Plan B, which is made by Barr Pharmaceuticals Inc.

"The FDA has the responsibility to make scientific decisions," she said. "For them to ask for public comment is so out of the ordinary that it strikes me as bizarre."

Clinton said she thinks the administration is "slow-walking" the issue and is reluctant to make any decision. "They know that a decision based on science would be an approval, but they have political allies that don't want to see that happen," she said. "Making the FDA subject to this kind of politics is very worrisome and harmful."

Wendy Wright, executive vice president of Concerned Women for America, which opposes the expanded use of Plan B, said her group submitted 30 pages of comments on regulatory, legal, medical and societal issues related to the contraceptive.

"We go beyond shallow slogans to deal with the real consequences that occur when this drug becomes easily available, and address the simple fact that FDA has no authority to approve Barr's marketing scheme," she said.


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