Top FDA Officials Were Not Part Of Plan B Decision

by Medindia Content Team on  May 25, 2006 at 8:20 PM Drug News   - G J E 4
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."

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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