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FDA official says agency doesn't need more regulatory powers

WASHINGTON—A senior Food and Drug Administration official backed off Thursday from calls for new and greater FDA regulatory powers over the drug industry.

Janet Woodcock, the FDA's acting deputy commissioner for operations, told members of the Senate Committee on Health, Education, Labor and Pensions that her agency needs no new authority from Congress to carry out needed reforms in FDA drug oversight. She said the agency intended to move faster to identify potential side effects of drugs in use and to do more to get drug-safety warnings to patients and physicians.

The FDA has faced fierce criticism in recent months for waiting nearly a year to require stronger warning labels for antidepressants after studies linked the drugs to suicidal tendencies in some children. The agency also was criticized for spending more than a year negotiating warning-label revisions with Merck & Co., the maker of Vioxx, after the drug was linked to heart problems and strokes.

In Thursday's testimony, Woodcock stepped back from two congressional reform proposals. One would allow the FDA to force drug companies to accept changes in warning labels. Another would permit the FDA to require companies to conduct clinical trials when concerns arose about the safety of drugs already on the market.

"We are now ... planning to put information out directly to the public on emerging safety issues," Woodcock said, adding that that's likely to eliminate the need for new warning labels or testing authority.

Her position that new authority from Congress isn't needed ran counter to testimony Tuesday before the same panel by Sandra L. Kweder, the FDA's deputy director for new drugs. Kweder told the committee that it would be "very helpful" if Congress gave the FDA authority to issue mandatory drug-warning labels and to require tests of drugs deemed risky.

Woodcock outranks Kweder, and her testimony, in its timing at least, supersedes Kweder's. Woodcock testified that the FDA had no official position on whether it needed new drug-regulation authority. She said the agency first wanted to see the recommendations of an Institute of Medicine study on how to improve FDA drug-safety oversight. That panel will begin its work later this year.

The drug industry contends that enhanced FDA authority is unnecessary.

Woodcock testified that the FDA's proposed Drug Watch Web page would post new drug-safety data and test results even before a label change was made.

"This new mechanism," she said, "should deal with this problem very effectively, by getting the information directly out to people who need it in a timely manner."

"I believe that the flow of information is a much more powerful tool," she said. That's what we need to concentrate on."

As for new FDA authority to force further tests of worrisome drugs, Woodcock said, "If there's a need for additional studies to be done, it's going to become quite apparent as we communicate the safety information."

Sen. Edward Kennedy, D-Mass., the committee's senior Democrat, said Thursday that he supported giving the FDA the power to require product-label changes and more clinical trials of potentially unsafe medications already in use.

Sen. Michael Enzi, R-Wyo., the committee's chairman, sounded reluctant. "We should not try to reinvent the wheel and develop a system that aims for an impossible standard of zero risk," he said.


(c) 2005, Knight Ridder/Tribune Information Services.

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