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FDA didn't follow normal procedures on contraceptive, GAO says.(Government Accountability Office)

Chicago Tribune (Chicago, IL)

| November 14, 2005 | COPYRIGHT 2007 Chicago Tribune. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Byline: Mike Dorning

WASHINGTON _ Top officials at the Food and Drug Administration already had decided not to allow over-the-counter sales of a controversial "morning-after" contraceptive months before the agency's safety review was completed, according to documents and accounts from several FDA officials contained in a new critical audit of the agency's actions.

The Government Accountability Office, Congress' investigative agency, concluded Monday that the FDA did not follow its normal procedures in handling the application to allow women easier access to the emergency contraceptive pill, which is sold under the brand name Plan B.

Nearly two years after a scientific advisory committee recommended that the emergency contraceptive be made available to women without a prescription, the FDA has yet to make a final decision.

In a review…

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