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FDA Plans New Board To Monitor Drug Safety

Independent Panel to Be More Open to the Public

By Marc Kaufman
Washington Post Staff Writer
Wednesday, February 16, 2005; Page A01

The Food and Drug Administration will create an independent board to more aggressively monitor the safety of drugs on the market as part of an effort to restore public confidence in the nation's prescription drug supply, Health and Human Services Secretary Mike Leavitt announced yesterday.

"The public has spoken, and they want more oversight and openness," he said to a gathering of FDA employees. "They want to know what we know, what we do with the information and why we do it."

Mike Leavitt says the public seeks "more oversight and openness." (Stephen J. Boitano -- AP)

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The Drug Safety Oversight Board would, for the first time, take the officials who approve new drugs largely out of the process of assessing whether side effects that appear later are serious enough to require quick regulatory action. FDA reviewers, some have argued, can be reluctant to withdraw a drug because it suggests their initial approval might have been a mistake.

As another part of its effort, Lester M. Crawford, FDA acting commissioner, said the agency -- known for its refusal to discuss issues before they are fully resolved -- will be far more proactive in providing information to the public. He said the FDA will release safety information even if it is not complete or if the release displeases drug companies.

"There are legal restrictions on releasing confidential and commercial information; however, that is not something the FDA should hide behind," said Crawford, who was nominated Monday to become FDA commissioner. "I think we need to adopt the mentality that the public wants to know and the public needs to know, and we should find reasons to make information available, rather than simply saying we can't reveal trade secrets . . . 'closed case.' "

Some members of Congress, consumer advocates and FDA staff members questioned whether the new safety reviews would be meaningful. But if they are, the two initiatives together will constitute a major shift in emphasis for an agency that has been accused in recent years of paying too little attention to drug risks and focusing instead on speeding new products to market.

David J. Graham, the FDA safety officer whose whistle-blowing brought the issue of unsafe drugs to prominence, said he does not think a new board would do much good.

"It's an important admission at the highest levels that the FDA hasn't handled drug safety up to now, but it won't address the root causes of the problem," he said. "Until drug safety becomes as important as approving drugs quickly, the fundamental problem will remain and unsafe drugs will continue to be approved and will stay on the market."

The FDA announcement came the day before the agency begins a high-profile three-day conference that will examine safety risks associated with the now-controversial class of arthritis drugs called COX-2 inhibitors. The FDA and the drug industry have been on the defensive since Merck & Co. took its blockbuster arthritis painkiller Vioxx off the market in September because of evidence that it increased the risk of heart attack and stroke, and Pfizer Inc. stopped advertising its similar Celebrex and Bextra products after receiving hints of similar problems two months later.

The FDA expert panel could recommend that all COX-2 drugs be withdrawn from the market or carry a stern "black box" warning of the risks, or it could vote to recommend no change in current regulations.

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