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Top FDA Officials Were Not Part Of Plan B Decision

by Medindia Content Team on May 25, 2006 at 8:20 PM
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Top FDA Officials Were Not Part Of Plan B Decision

The former U.S. Food and Drug Administration chief Commissioner Lester Crawford prevented two senior officials from deciding the course of action on Barr Pharmaceuticals Inc.'s Plan B, which is a 'morning after' pill.

These statements were contained in the transcripts released by the non-profit Center for Reproductive Rights. Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research said that he was thing of approving the action to sell Plan B as a OTC drug. But Crawford "told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application."

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He said that Crawford was apparently concerned about the packaging of the drug. Plan B is an emergency pill that can prevent conception if taken within 72 hours after sexual intercourse. Crawford was confirmed in July 2005, but resigned abruptly in September 2005.

Dr. Janet Woodcock, a deputy FDA commissioner also said that she repeatedly asked Crawford about Plan B. "Ordinarily, I would have been more involved, but not in all cases. In this case, I was not involved," Woodcock, said. The Center for Reproductive Rights said that the FDA behaved unusually in this case. "The more we learn about the FDA's decision-making around Plan B, the more we know that the agency violated its own precedents," attorney Simon Heller said.
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