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  F.D.A.'s Rejection of Contraceptive Is Questioned
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ContributorArmyDem 
Last EditedArmyDem  Nov 14, 2005 05:56pm
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MediaNewspaper - New York Times
News DateMonday, November 14, 2005 11:55:00 PM UTC0:0
DescriptionBy MARIA NEWMAN
Published: November 14, 2005

The Food and Drug Administration did not follow its usual procedures in rejecting an application for over-the-counter sales of the emergency contraceptive pill Plan B, the investigating arm of Congress found today.

The Government Accountability Office also said in its 57-page report that there were questions about whether top officials of the F.D.A. made the decision to reject the application for over-the-counter sales of the drug, which is opposed by some religious conservatives, even before its own advisory committee had issued its recommendation on the matter.

Several legislators and scientists have complained that the F.D.A. was putting politics ahead of science in its handling of the contraceptive, which can be used as emergency, morning-after contraception.

The G.A.O. said in its report that "the Plan B decision was not typical of the other 67 proposed" changes from prescription to over-the-counter sales that the agency received from 1994 through 2004.

The agency, which was charged with examining how the decision to reject the application was made, and how it compared to the decisions of other requested changes from prescription to over-the-counter sales, does not make recommendations about what action the F.D.A. or Congress should make in the matter.

But critics of the decision used the report as the basis to ask that the F.D.A. decision be revisited.

"We are deeply opposed to this subversion of science," Representative Henry Waxman, Democrat of California, wrote to Health and Human Services Secretary Mike Leavitt, in a letter signed by 17 other lawmakers.
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