FDA Pick Was NYC Health Chief

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By Rob Stein and Lyndsey Layton
Washington Post Staff Writers
Thursday, March 12, 2009

The Obama administration has tapped Margaret A. Hamburg, a physician and former New York City health commissioner with an interest in bioterrorism, to run the struggling Food and Drug Administration, according to people familiar with the choice.

Joshua Sharfstein, Baltimore's health commissioner, will serve as Hamburg's chief deputy, according to these sources. Sharfstein won national attention when he took on the drug industry and petitioned the FDA in 2007 to restrict the use of over-the-counter cough and cold medications for young children.

The White House would not confirm the selections yesterday. Hamburg, 53, could not be reached for comment; Sharfstein, 39, declined to talk to a reporter.

The pair, both outsiders, would take on an agency in crisis. Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for a quarter of consumer spending in the United States, including over-the-counter and prescription medications, food and medical devices such as heart valves and artificial hips. But morale within the FDA plummeted as a result of accusations of ideological bias and tilting toward industry.

The agency has been lambasted on Capitol Hill for a series of food-borne illnesses, the most recent of which is an ongoing salmonella illness outbreak that has sickened 700 people and killed nine. It has been slammed by its own scientists for approving medical devices without proper vetting. And it has been unable to ensure the safety of imported goods pouring into the United States from around the world, including food, drugs and raw materials.

"We look forward to working with Doctor Hamburg to ensure that our country continues its leadership in scientific research and innovation across the world, bringing hope to patients and their families battling cancer and other life-threatening disease," said Ellen V. Sigal, chairwoman of Friends of Cancer Research.

Some questioned whether Hamburg has enough knowledge of the FDA. "She had a very impressive track record in New York, and the question is: Can she bring that to this underfunded, dysfunctional agency?" said Diana Zuckerman, president of National Research Center for Women and Families.

Hamburg, who would have to be confirmed by Congress, grew up on the campus of Stanford University, the daughter of two physicians. Her mother, Beatrix, was the first African American woman to attend Vassar College and to earn a degree from the Yale University School of Medicine. She has credited her Jewish father, David, for teaching her to fight discrimination.

Hamburg graduated from Radcliffe College and Harvard Medical School. From 1986 to 1988, she served in the U.S. Office of Disease Prevention and Health Promotion, and from 1989 to 1990 she was assistant director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

In 1991, Hamburg became health commissioner of New York City. In 1997, she became assistant secretary for planning and evaluation at the Department of Health and Human Services in the Clinton administration, where she created a bioterrorism program.

Since 2001, she has been vice president for biological programs at the Nuclear Threat Initiative, a think tank focused on the threat from nuclear, chemical and biological weapons. Hamburg is married to Peter Fitzhugh Brown, an artificial intelligence expert who is executive vice president and director of Renaissance Technologies, a privately owned hedge fund.

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