Tuesday, November 15, 2005

On This Day in History: Courtesy of News Links

GAO Confirms FDA Put Ideology Before Science On Plan B

Think Progress brings us this excerpt from the GAO report on the FDA's rejection of the application to make "Plan B" contraception available over the counter.

FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations43 and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner. … Both office reviews were not completed until April 2004.

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