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FDA to create panel to monitor prescription drugs

WASHINGTON—In a move designed to quiet mounting criticism of its regulation, the Food and Drug Administration said Tuesday that it plans to establish an independent board to monitor the safety of prescription drugs now being sold to consumers.

The FDA also plans to launch a new drug watch Web page in which it will post and update data about the safety, risks and possible side effects of drugs that might be dangerous for patients. In addition, the agency wants to provide one-page information sheets that inform health care providers and patients of all the drugs listed on the new Web page.

Health and Human Services Secretary Michael Leavitt described the moves as a new FDA effort toward transparency in regulating the prescription-drug industry.

The FDA has been battered recently for a string of miscues that raised questions about the agency's effectiveness in keeping Americans safe from the dangers of modern pharmaceuticals. It delayed issuing strong warning labels on antidepressants even though studies indicated they caused suicidal tendencies in children and teens. It also approved popular arthritis painkillers, Vioxx and Celebrex, even though studies linked both to heart attacks and strokes.

Starting Wednesday, the FDA will hold three days of hearings on the class of painkillers that includes Celebrex and Bextra to decide whether to keep them on the market.

Health experts called the FDA's new oversight initiatives a positive step toward improving public confidence in the embattled agency. Many have long called for an independent FDA safety oversight board.

But experts also said the lack of specifics makes an assessment of the proposals' effectiveness impossible. They cautioned too that more changes are needed to address the FDA's most important challenge: ensuring that the drugs it approves are, in fact, safe.

"I think this sounds like a good initial step, but it's not a solution to the problem. And anyone that thinks this is a solution to the problem misunderstands the problem," said Dr. Bruce Psaty, a professor of medicine, epidemiology and health services at the University of Washington in Seattle.

During recent congressional hearings, FDA officials defended the agency's efforts to monitor the safety of prescription drugs already in use. But consumers, patient advocates and health experts want more intense FDA scrutiny to ensure public safety.

Leavitt, who took over as HHS secretary last month, said he understands.

"The public has spoken and they want more oversight and openness," Leavitt told employees at the FDA's headquarters in Rockville, Md. on Tuesday. "They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence."

The new proposals come as the Institute of Medicine, a national health advisory agency, completes a study on how the FDA can improve its safety surveillance of drugs in the marketplace. Currently, the FDA relies on drug companies and physicians to report problems with drugs instead of actively looking for potential problems.

And the FDA does nothing to ensure that drugs approved by the agency for one purpose aren't prescribed for another. That practice, called off-label prescribing, has been growing in recent years.

The proposed new board is good news for consumers, the FDA and the drug industry, said Dr. Alastair Wood, associate dean and professor of medicine and pharmacology at Vanderbilt University. Wood called for an independent FDA drug oversight board in a 1998 New England Journal of Medicine article.

But he also called on the FDA to make the drug approval process more transparent. The current proposals offer no such improvements.

"They need to make sure there's an approval process that's open and transparent and that people can have confidence in. Not one that's behind closed doors in negotiations between drug companies and the FDA," Wood said.

The new board will oversee drug safety issues within the FDA's Center for Drug Evaluation and Research. It will include members from the FDA and medical experts from other HHS agencies and government departments, including the Department of Veterans Affairs. Board members will be appointed by acting FDA commissioner Lester Crawford, who was nominated Monday by President Bush to become the FDA's permanent commissioner.

The board will help lift the veil on agency decision-making by expanding information about its drug safety activity to health care providers and the public. It will mediate disputes between FDA officials who handle new drug approvals and those who monitor the safety of drugs already on the market. Critics have said the FDA approval division has resisted attempts by the drug safety office to take action against medications that have been shown to have problems.

When similar problems arise, the new board will mediate those disputes and make recommendations for action to Dr. Steve Galson, FDA acting director of the Center for Drug Evaluation and Research.

The drug industry supports efforts to improve the quality of drug information used by patients, health care professionals and the FDA, said Jeff Trewhitt, a spokesman for the leading drug industry trade group, Pharmaceutical Research and Manufacturers of America.

But FDA actions regarding problem medications should be "based on sound science and reflect carefully considered judgments regarding both the benefit and risk" of medications, Trewhitt said.

"We are studying the details of the proposed oversight board to determine how it would work," he said. "We have lots of questions just like everybody else."

Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association, said that to be successful, the board must have parity in workforce, resources and authority with other departments it deals with.

"The question of whether this is a baby step or a giant step in the right direction can't be answered until we have more answers or until we watch how it functions," DeAngelis said. "The devil is always in the details."


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

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