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."

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.

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.

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.