FDA Poised for More Aggressive Approach

By Lyndsey Layton
Washington Post Staff Writer
Thursday, August 6, 2009 4:05 PM

Margaret A. Hamburg, commissioner of the Food and Drug Administration, said Thursday that her agency will take a faster, more aggressive approach to enforcing regulations and laws.

"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible," Hamburg told the Food and Drug Law Institute in a noontime address.

Hamburg said she was making changes to FDA's internal processes to streamline and speed up the way it enforces regulations governing the safety of food, drugs and medical devices.

"In some cases, serious violations have gone unaddressed for far too long," Hamburg said. "These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising."

Hamburg, who has been on the job for eight weeks, said the FDA has often been hampered by lengthy internal debates and prolonged negotiations with violators, she said.

"Frankly, I can see in some past responses, there's a lot of back and forth, a lot of stall and delay, [the attitude of] 'let's wait and see what the company does,' " Hamburg said. "We need to be as clear as we possibly can about our expectations and standards, and when there are ongoing problems or when a problem emerges that has as serious impact on health, then we have to aggressively act."

For example, the FDA will no longer issue multiple warning letters to violators before taking enforcement action, Hamburg said. And if there is a "significant" threat to public health, the FDA might act before it even sends a formal warning letter, she said.

Hamburg said she thinks tough enforcement will act as a deterrent to companies who might otherwise violate the law. "Ultimately, the FDA's success should be measured not by the number of warning letters or injunctions or seizures but by our impact on the health and welfare of the public. Enforcement of the law is not simply an end in itself -- enforcement is critical to the agency's public health mission."

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