Thursday, May 25, 2006

FDA - Ex Commish Crawford and Plan B

Circumventing normal practices, the nation's top drug regulator seized control of a request to sell the "morning-after" pill without a prescription and delayed the drug's approval, two senior Food and Drug Administration officials told lawyers suing the agency over the decision.

Lester M. Crawford, then acting commissioner of the FDA, intervened in early 2005 as the agency's staff was preparing to authorize over-the-counter sales to women 17 years and older, the two FDA officials said in sworn depositions last month.

The two officials, Dr. Janet B. Woodcock and Dr. Steven Galson, said Crawford effectively cut them out of a process they normally participate in and handled the matter by himself. The two were interviewed for a suit filed by the New York-based Center for Reproductive Rights.

More here.

Insider's view: is here.

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