by Jessica Bosari

Created on: March 15, 2009

If Obama wants to bring change to the FDA, he has chosen the right woman. Dr. Margaret Hamburg, former New York City Health Commissioner, has shown herself to be tough, ethical and powerful leader.

Proven Track Record

From 1991 to 1997, Hamburg took a downtrodden and ailing NYC Health Department and turned it into a strong agency. When she took office, HIV and tuberculosis had reached epidemic proportions amongst budget cuts and low morale. She even went so far as to force TB treatment on patients who refused, arguing for the greater good. Although controversial at the time, Hamburg has been praised for instituting a need exchange program that reduced the spread of HIV. Her leadership has created a stronger agency with greater morale.

Credentials

Hamburg has the credentials for the job, with a Harvard University medical degree. She participated in neuroscience research at the National Institutes of Health and Rockefeller University. She also worked at the National Institute of Allergy and Infectious Diseases, focusing on AIDS research.

Dr. Hamburg has experience in federal policy issues, working at the Department of Health and Human Services. In addition, she has been spending time on bioterrorism research at the Nuclear Threat Initiative.

The Leadership the FDA Needs

Hamburg's experience will offer the FDA the guidance and leadership it needs. The agency has struggled for many years from poor funding and lax oversight. The manufacturers have influenced nearly every approved drug or medical device in recent years. The morale of FDA workers has suffered under this culture.

Many criticize the FDA for failing to inspect food production facilities properly, resulting in the recent salmonella outbreaks. Defenders point to a lack of funding to hire the inspectors needed to prevent outbreaks.

Approval Pending

Hamburg's nomination will still need approval by the Senate. If approved, she may face the added challenge of tobacco regulation and a separate food agency, both changes being considered by Congress. In addition, it remains to be seen just how strong the medical and drug industry's grip is on the FDA. Let us hope Hamburg will use her gritty New York tough-mindedness to handle these good old boys who are used to getting their way.

The imminent nomination of Dr. Margaret Hamburg is a step in the right direction. The Obama administration is sending a strong signal to the drug companies that the culture railroading and of lobbying at the FDA will soon end.

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