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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."
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. <
Another record-breaker, for Lil' Dumbya!>
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.
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."