Shake-ups at the Food and Drug Administration
Posted by David Bruggeman on August 20, 2009
A head medical device regulator has resigned and the director of drug approval has been named in an ethics investigation at the Food and Drug Administration (H/T Scientific American‘s 60-Second Science Blog). The Director of the Medical Device Division, Daniel Schultz, resigned amidst a string of product recalls and allegations of inappropriate pressure on agency scientists (where was Chris Mooney?). Janet Woodcock, head of drug evaluation, is under investigation for a possible conflict-of-interest violation. She has collaborated with a researcher from one company, Momenta, that is competing with another company, Amphastar, on a generic version of a blood thinner. Amphastar has applied for approval, and is still waiting 6 years after application.
If additional personnel changes or investigations surface over the next few months, this would suggest that FDA Commissioner Hamburg is seeking to improve the agency’s tarnished reputation and/or shift the regulatory burden toward industry. Given the nature of the products at issue in this agency, it seems the appropriate balance.
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