FDA Pick Spent Life 'Preparing For This Job'

President Obama named Margaret Hamburg as his choice to lead the Food and Drug Administration. Hamburg led New York City through a tuberculosis epidemic as health commissioner in the 1990s.

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JACKI LYDEN, host:

Welcome back to ALL THINGS CONSIDERED. I'm Jacki Lyden. President Obama today named his choice to head the Food and Drug Administration. He said he made the choice because of his concern about the lack of inspection in America's food supply.

President BARACK OBAMA: That's a hazard to public health. It's unacceptable, and it will change under the leadership of Dr. Margaret Hamburg.

LYDEN: NPR's Joanne Silberner reports on Margaret Hamburg's qualifications to lead the Food and Drug Administration.

JOANNE SILBERNER: If Margaret Hamburg wins Senate confirmation, she'd be taking charge of an agency in trouble, says William Hubbard. For 13 years before retiring, he was the policy chief at the FDA.

Mr. WILLIAM HUBBARD (Former Policy Chief, United States Food and Drug Administration): I think the president's remarks are a reflection of the dire concerns many in Congress and among the public have about our food safety system, that there's just a concern that FDA can't protect us from unsafe food.

SILBERNER: And there are concerns that the agency has been approving drugs too rapidly and not monitoring them well once they're on the market. There are questions about products from cloned animals, and the use of antibiotics in farm animals.

Meanwhile, Congress is considering taking food safety away from the FDA and creating a whole new agency. At the same time, it's considering whether to give the FDA an active role in regulating tobacco.

But Hubbard says Hamburg's experiences as New York City health commissioner, among other things, means she can handle this.

Mr. HUBBARD: You could argue she has spent her life preparing for a job like this by being a public health official. She has the skill, the experience, the commitment to public health that's probably perfect for this sort of challenge.

SILBERNER: Former FDA commissioner Donald Kennedy has known Margaret Hamburg since she was a child. Kennedy and Hamburg's parents were all professors at Stanford University. He's watched as Hamburg, now 53 years old, made her way through the world.

Mr. DONALD KENNEDY (Former Commissioner, United States Food and Drug Administration): I would characterize her in two ways: being very, very smart and thoughtful, and also calm.

SILBERNER: Calm.

Mr. KENNEDY: When she's facing a complicated situation, she has a great sense of being unbothered, being cool. She's a lot like Obama himself in that respect, I think.

SILBERNER: Hamburg has faced some challenging situations in her career, especially during those six years in the 1990s, when she was New York City health commissioner. There was a tuberculosis epidemic. Hamburg instituted an aggressive program to find people with TB and make sure they took their medications.

She's not talking to the media at the moment, as is the practice of most appointees awaiting Senate confirmation, but at the time of the TB epidemic, she said this:

Dr. MARGARET HAMBURG (Nominee, FDA Commissioner): We do have individuals who have been repeatedly noncompliant, and that's why we feel we also, as public-health officials, have to have the power to take more aggressive action in those cases so that we can protect the health of the public.

SILBERNER: As commissioner, she convinced the New York City mayor to let her give clean needles to drug addicts to help stem the AIDS epidemic, an action supported by research but not popular politically. And she had the unique experience of having her own signature show up twice on her two children's birth certificates, once as mother and once as health commissioner.

Hamburg has been a medical researcher. She's worked on policy issues at the Federal Department of Health and Human Services. Most recently, she's been working on bioterrorism issues at a think tank.

Hamburg will have to step down as a member of the board of a company that sells medical products and generic drugs but so far, no red flags. In fact, it's hard to find anyone who is not enthusiastic about Obama's choice.

The prescription drug manufacturers' trade group didn't have anyone available to talk about Dr. Hamburg, but they did issue a statement saying they applaud the selection. Joanne Silberner, NPR News, Washington.

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Former NYC Health Chief Picked To Lead FDA

President Obama's nominee for FDA commissioner — Dr. Margaret Hamburg — has held one of the toughest jobs in public health.

From 1991 to 1997, Hamburg was New York City's health commissioner, overseeing what had been a storied but demoralized department facing the HIV epidemic and budget cutbacks. A New York Times editorial credited her with raising agency morale and channeling money back to the department.

Her experience could serve her well at the FDA, as low morale ripples through an agency considered underfunded, even by members of Congress who have criticized the FDA for lax food safety oversight and drug approvals.

Controversial Initiatives In New York

At the New York City health department, Hamburg fought a tuberculosis epidemic by beefing up the city's ability to force treatment on people infected by the TB bacteria.

"As public health officials [we] have to have the power to take more aggressive actions in those cases," she said at the time, "so that we can protect the health of the public."

And she instituted a politically controversisial needle-exchange program to prevent HIV transmission in drug users.

Road To The FDA

Born in 1955, Hamburg grew up on the Stanford University campus, where both her parents were physicians and academics. Her mother was the first African-American to go to Vassar College; Hamburg credits her Jewish father with teaching her values.

With undergraduate and medical degrees from Harvard University, Hamburg went on to do neuroscience research at Rockefeller University and the National Institutes of Health, and later worked on AIDS issues at the National Institute of Allergy and Infectious Diseases.

From New York City, she moved to the federal level, working on policy issues at the Department of Health and Human Services. Hamburg is also a senior scientist at the Nuclear Threat Initiative, where she has been focusing on bioterrorism.

Changes Ahead

If confirmed by the Senate, Hamburg will be walking into a tough job. Members of Congress are considering giving the agency oversight over tobacco. Congress is also considering legislation that would create a separate food agency.

Health officials say if anyone can pull the agency together and make it work, it's Hamburg. Former FDA Commissioner Dr. Donald Kennedy says he can think of no one better. Dr. Georges Benjamin, head of the American Public Health Association, cites her broad experience in policy, science and administration.

"FDA needs somebody who's highly ethical and can build and lead a team, I think Dr. Hamburg is the right person for that," Benjamin said.

Challenge To The Drug Industry

The Obama administration has also named a deputy FDA administrator, Joshua Sharfstein. He's currently head of the Baltimore City Department of Health. Like Hamburg, he's a physician with undergraduate and graduate degrees from Harvard. Sharfstein worked for several years on Capitol Hill for Rep. Henry Waxman (D-CA), now head of the Energy and Commerce committee, which oversees health issues. Sharfstein worked on health issues and gained a reputation as a very bright go-getter.

He recently made a name for himself by starting a successful movement to limit the use of cold and cough medicines in children, something not likely to make him popular with over-the-counter drug companies. His position as deputy commissioner needs no Senate confirmation.

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