President Obama has decided to nominate former New York City Health Commissioner Margaret Hamburg to head the Food and Drug Administration, turning to a onetime Clinton administration official to help right the beleaguered regulatory agency, a source briefed on the choice said Wednesday.
Hamburg, 53, a physician who has worked extensively on bioterrorism issues, is a senior scientist at the Nuclear Threat Initiative, a Washington-based foundation focused on threats from nuclear, biological and chemical weapons.
Though less experienced as a regulator, Hamburg has extensive government experience. She served as health commissioner in New York for six years in the 1990s before becoming assistant secretary for planning and evaluation at the Department of Health and Human Services in 1997.
Another leader in public health, Baltimore Health Commissioner Joshua Sharfstein, 39, is widely expected to be named Hamburg’s deputy.
A pediatrician by training, Sharfstein led the Obama transition team’s assessment of the FDA. He also has worked as an aide to Rep. Henry A. Waxman (D-Beverly Hills), a leading critic of the pharmaceutical industry.
The president will be looking to Hamburg and Sharfstein -- choices first reported by the Wall Street Journal -- to strengthen the FDA’s regulatory oversight after controversies involving its drug and device approvals and its response to a series of outbreaks of food-borne illness.
Just two months ago, inspectors from the Government Accountability Office, the investigative arm of Congress, said the agency was fast-tracking approvals of medical devices without sufficient review.
And agency scientists recently called on the Obama administration to remove senior medical device regulators whom they accused of corrupting the FDA’s review process.
“Current senior FDA employees are too close with the industries they regulate,” said Rep. Bart Stupak (D-Mich.), a frequent critic who chairs the House Energy and Commerce subcommittee on oversight and investigations. “The new FDA commissioner must recognize that the FDA works for the American people, not drug companies and food producers.”
Other critics complain the agency has been too slow to approve generic drugs that could help reduce healthcare costs.
Lawmakers, meanwhile, have been agitating to transfer to a new agency the FDA’s responsibility for regulating food, a drive that has gained momentum with each food scandal. The FDA is still wrestling with last year’s deadly salmonella outbreak involving a Georgia peanut processing plant. More than 600 people were sickened in the months-long outbreak, and at least nine died.
FDA leaders have taken some steps to respond to the criticism, including increasing their focus on overseas inspections. But much of the reform effort has been on hold as the Obama administration worked to fill the agency’s top posts.
The FDA has not had a commissioner since December, when President George W. Bush appointee Andrew von Eschenbach resigned.
As health commissioner in New York, Hamburg was widely praised for a major initiative to control the spread of tuberculosis, reducing the city’s infant mortality rates and boosting child immunizations. She sits on the board of medical supply distributor Henry Schein Inc., but would have to surrender the position if confirmed by the Senate.
Hamburg would have a great deal of work to do at the FDA, said Rep. Rosa DeLauro (D-Conn.), a leading champion of stronger federal regulation of food.
“The next commissioner faces a significant and long-term challenge in changing the culture at the agency and ensuring that the FDA once again emphasizes independent science,” DeLauro said.