FDA Commissioner Faces Formidable To-Do List

By Lyndsey Layton
Washington Post Staff Writer
Wednesday, June 17, 2009; 5:28 AM

Margaret A. Hamburg, the new commissioner of the Food and Drug Administration, wants to reorient the sprawling bureaucracy and remake it into the key federal agency that protects public health.

"It really goes back to what the FDA was about from the very beginning: a very clear public health mission but with a regulatory framework for action," Hamburg said yesterday, adding that she wants to increase transparency and pump up enforcement.

"The FDA has been seen as a cold regulatory agency and also something of a black box," she said. "We have a chance to open it up and make sure the American people have the safe, high-quality foods they need, the safe and high-quality drugs and medical equipment they need."

With nearly 11,000 employees, 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.

During the Bush administration, consumer groups charged that the FDA was making decisions on the basis of political ideology and not science. The agency was lambasted on Capitol Hill for a series of food-borne illnesses, the most recent of which was a salmonella outbreak that sickened 700 people, killed nine and prompted the largest recall in U.S. history.

The FDA also 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.

"When I was first talking to the administration and the vetting process was going on, suddenly I realized that every day there was some story about a really bad situation and the FDA, and I thought, 'Do I really want this job'?" she said.

She decided yes, and started work four weeks ago, after her Senate confirmation. "I've been really impressed by the dedicated staff," she said. "There's a lot to be done, but I don't think it's a patient in crisis. I think it's really important to restore confidence, to restore faith that the FDA is going to use the best available science and has real integrity."

Hamburg, a Harvard-trained physician, is a former health commissioner of New York City and was an assistant secretary at Health and Human Services during the Clinton administration. Most recently, she was vice president for biological programs at the Nuclear Threat Initiative, a think tank.

In the short time that Hamburg and her principal deputy, Joshua Sharfstein, have been running the agency, the FDA has announced nearly daily warnings about various consumer products. Yesterday, the agency warned the public not to use three Zicam brand over-the-counter cold remedies because they have caused some people to lose their sense of smell.

"We've changed our posture to one that is more aggressive and forward leaning," Hamburg said.

At her direction, Sharfstein is chairing an internal task force to recommend ways to release more information about FDA decisions and policies. The agency has long been criticized for keeping private information about drugs or devices under study, even when the products are linked to serious health problems or deaths.

Hamburg's to-do list goes beyond reorienting and restoring public confidence in the FDA. Last week, Congress passed historic legislation that gives significant new authority and responsibility to the FDA to regulate tobacco for the first time. That means Hamburg must create a new center within her agency to handle oversight of the manufacturing, marketing and sale of cigarettes, cigars and other tobacco products.

And today a House committee takes up legislation that would give FDA broad new powers to regulate food safety -- a bill that House leaders are determined to pass this year. The bill would place greater responsibility on the food industry to prevent food-borne illnesses and would require the FDA to significantly expand its inspection and oversight of the industry.

Hamburg's days are jammed; she conducted an interview while being driven from Health and Human Services headquarters across town to the Brookings Institution. She says she is determined not to let the work overwhelm her life and makes it a point to try to eat dinner with her husband and two teenage children, toting home a briefcase filled with 10 pounds of work each night. She falls asleep reading briefing books.

"The first weeks have been very full," she said. "And my learning curve is extremely steep."

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