Turmoil at FDA! Device Chief Out, Drug Chief Investigated

Published On: August 12th, 2009

FDA It’s an FDA two-fer this morning, with an investigation of one senior official and the departure of another.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, is under investigation for an alleged conflict of interest, the WSJ reports. The Health and Human Services inspector general is looking into a complaint from a company called Amphastar Pharmaceuticals, which alleges that Momenta Pharmaceuticals ,one of its rivals in developing generic blood thinners, had special access to Woodcock. The FDA said it is aware of the allegations, and did not make Woodcock available for comment.

Daniel Schultz, head of the agency’s medical device division, said yesterday that he’s resigning. His departure is “by mutual agreement” with Obama’s FDA commissioner, Peggy Hamburg. As the WSJ notes, there have been questions from Chuck Grassley about devices that were approved over the objections of scientists and doctors within the FDA, as well as allegations from within the agency of similar issues.

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Turmoil at FDA! Device Chief Out, Drug Chief Investigated

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