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Reports: Margaret Hamburg to Head FDA

The Obama Administration has chosen a new chief to head the U.S. Food and Drug Administration, according to media reports. She’s Margaret Hamburg, 53, the New York City health commissioner in the 1990s and later an official at the Department of Health and Human Services, where she specialized in bioterrorism and planning a response to a potential flu epidemic. Hamburg’s deputy will be Joshua Sharfstein, the Baltimore City health commissioner who was himself frequently cited as a contender for FDA’s top job, according to reports.

Hamburg’s name hadn’t topped the unofficial shortlist for FDA chief that has been circulating for several months—in addition to Sharfstein, other candidates being bandied about included cardiologist Steven Nissen of the Cleveland Clinic, a longtime critic of FDA and its ties to industry, and Robert Califf, a Duke cardiologist and clinical trialist.

The choice of commissioner was a delicate one for the new Administration. FDA has been heavily criticized for years for failing to act decisively in the face of public health threats, from tainted peanuts to risky drugs it allowed to reach the market. In addition, the pharmaceutical industry provides tens of millions of dollars to the agency in the form of user fees—a substantial portion of FDA’s funding. Obama has made no secret of his interest in reforming FDA, telling NBC’s Matt Lauer last month that “we’re going to be doing a complete review of FDA operations.” Hamburg, however, may be less divisive and less alienating to industry than some of the other candidates, such as Nissen.

The agency faces numerous challenges: Its budget, about $2.2 billion, is often derided as inadequate; it has been accused of conflicts of interest in neglecting to address safety issues of drugs it approved; its device division has been under fire for failing to scrutinize medical devices before they’re approved; and its resources are too limited to adequately inspect imported food and drug products. FDA has also been criticized for politicizing scientific decisions, such as those around the emergency contraceptive Plan B.

FDA's small budget needs to change, says Frank Torti, the agency's acting commissioner since 20 January. (Torti took over from FDA commissioner Andrew von Eschenbach, who headed the agency in the last years of the Bush Administration.) In an interview with Science last month, Torti noted that FDA doesn’t fund nearly all the science it should. He described wandering up to a poster discussing salmonella by FDA researchers, “and I say, ‘I presume the food agency funded that,’ and they say, ‘Oh, we would never have the money to fund that—it was the Department of Homeland Security that felt sorry for us and gave us the money.’ ” (Ironically, fake news organization, The Onion, posted a story about FDA and salmonella yesterday.)

How much leverage Hamburg and Sharfstein will have to change FDA's culture and budget will depend on the whims and generosity of Congress and the willingness of the Obama Administration to back them—not to mention support from those inside the agency. Hamburg hails from an illustrious public health family; in addition to her own impressive resume, her parents, Beatrix and David Hamburg, published pioneering work on stress and violence. (David Hamburg also served as chair of the board of the American Association for the Advancement of Science, which publishes Science.)

Photo Courtesy of U.S. National Library of Medicine, National Institutes of Health