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FDA Plans New Board To Monitor Drug Safety

In advance of the conference, the New England Journal of Medicine released two editorials and three studies yesterday assessing the COX-2 drugs and the FDA's performance. The studies generally concluded that the entire class of drugs increases the risk of cardiovascular disease. The editorials took the agency and industry to task for not adequately protecting the public.

"As we apply new science to develop new medicines, we must not forget that our first job is to do no harm," journal editor Jeffrey M. Drazen concluded in his commentary.


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

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Planning for the new drug review board is not complete, but Leavitt and Crawford said that while the board would still be made up of FDA and other federal medical officials, it would not include FDA medical officers or drug review officers who might be reluctant to overturn their own earlier decisions.

In addition, the board would be encouraged to seek advice from the heads of the FDA's numerous expert advisory panels and from some public interest groups. The panel would be allowed to call drug companies before it to explain troubling information, but Crawford said the companies will not address the board unless invited.

Crawford said that he does not think the agency needs additional authority to set up the review board, but some in Congress disagreed and said they will move ahead with legislation.

Among the sharpest critics of the FDA's handling of drug safety issues has been Sen. Charles E. Grassley (R-Iowa), who has called for a major revision of the agency's drug safety effort. Grassley welcomed creation of the drug review board but said he remains concerned about the independence of the panel.

"I'm drafting legislation to clearly establish this independence and provide the office the authority needed to do its job," he said. "In addition, it remains necessary that Congress require a clinical-trials registry to bring more transparency to the studies used to determine the safety of prescription drugs."

Rep. Maurice D. Hinchey (D-N.Y.), another vocal critic of the FDA, called the review board a "farce" and said, "The real problem with the FDA is that it remains far too closely tied to the pharmaceutical industry."

At Pharmaceutical Research and Manufacturers of America, spokesman Jeff Trewhitt said, "We're in the process of digesting the details of the drug safety board and how it will work."

Trewhitt said the industry "supports efforts to address the quality of information used by the agency, health care professionals and patients" but added: "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both risk and benefit."

Daniel E. Troy, the FDA's chief counsel until several months ago, voiced a concern that the new policy could slow the approval of new drugs. He said the board "may well be a good idea" but it shouldn't "focus overly much on the drug safety side" and added: "It must be staffed with people who will bring a balanced perspective, keeping in mind at all times the value of new drug therapies."

Troy also said that he feared the board, and the heavy attention paid to drug safety in recent months, could have a "chilling effect" on FDA drug reviewers, reducing their willingness to approve applications.

The FDA already has a 110-member Office of Drug Safety, which Crawford said will remain intact.


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