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Transforming FDA

 
 
Mar
12

Margaret Hamburg is said to be President’s Obama’s choice for FDA commissioner, according to the Los Angeles Times. The agency has been without a leader since Andrew von Eschenbach resigned in December. If confirmed by the Senate, Hamburg will have to confront such issues as a recent GAO report that says FDA is not properly reviewing medical devices and complaints by some agency scientists about a corrupted review process.

The 53-year-old Hamburg is a former New York City health commissioner, a physician, and a bitoterrorism expert. It is expected that she will be assisted by Baltimore health commissioner Joshua Sharfstein—Obama’s likely pick for deputy commissioner, according to Bloomberg. Sharfstein is a pediatrician, who led Obama’s transition team’s assessment of FDA. He also served as an aid to Rep. Henry Waxman, an often vocal critic of the device industry.

Ray Woolsey, president of the Critical Path Institute, tells Bloomberg that, “FDA is a public health agency and to have two public health leaders at the helm is a clear signal of the right direction for the agency.” Of course, no matter how committed Hamburg and Sharfstein are to reform, great leadership may not be enough to overcome the agency’s severe lack of funds. “The agency is regulating 25% of everything we touch every day, and it has a budget that hasn’t gone up in 20 years,” Woosley tells Bloomberg.

 
 
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