Can a tough, persuasive Hamburg overhaul FDA?

Q: Can Dr. Margaret Hamburg (photo) pull off an FDA turnaround? A: Well, she took over New York's health department when it was in crisis and put the agency back on its feet. Expect to hear much more along these lines today as the Obama administration's nominee for FDA Commissioner faces a grilling by Senate committee. But don't expect it to turn nasty; most observers predict Hamburg will be confirmed.

To prep us for Hamburg's probable takeover at the FDA, the New York Times has assembled a profile painting her as a stubborn, determined and independent type who sorts out tough problems with alacrity. Example: Her handling of tuberculosis in New York, when she persuaded the powers that be to let her detain TB patients until cured and convinced cash-strapped city leaders to build a new TB hospital in 90 days."It's not rocket science, but three health commissioners before her had not done it," one of her associates told the Times.

Hamburg also comes off as immensely persuasive in a quietly non-confrontational way: "I listened to her," ex-Mayor David Dinkins said. "She's got that ability."

Well, she'll need that ability and more at the FDA, which has been hammered for a series of snafus over the past couple of years. Its own Science Board called the agency out for its behind-the-times science and outdated technology and systems. Rebellious staffers have pleaded with the president to root out a politics-trumps-science attitude that they say has corrupted the approvals process. And drug and food safety scandals have exposed big-time holes in the agency's inspection and surveillance methods.

- read the NYT story

ALSO: For her part, Hamburg says the first thing she'll do if confirmed is review the FDA's response to the H1N1 flu situation; other priorities include boosting FDA credibility, increasing the monitoring of medical products, and fostering innovation. Report

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