November 15, 2005

Drug Regulation for Women, Rove Style

New York Times has the best description of the GAO report out Monday in which it is made clear at least to me that the FDA killed morning after contraception in a political charade
The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration's May 2004 rejection of the morning-after pill, or emergency contraceptive, application was unusual in several respects.

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded...

The report suggested that it quickly became apparent that the agency was not going to follow its usual path when it came to the pill. "For example," it said, "F.D.A. review staff told us that they were told early in the review process that the decision would be made by high-level management."

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