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The role of outside experts with industry ties will be limited when it comes to recommending approval of a new drug or medical device, the US Food and Drug Administration (FDA) announced yesterday. The FDA hires medical experts to serve on advisory panels that advise the agency on how to proceed with any new drug.
However most of these experts have financial conflicts and are often paid by drug companies. They are unable to give an unbiased view, due to which the FDA has faced severe criticism from all quarters. The advisory committees are vital links between the FDA and the public. They serve to recommend new drugs, diagnostic tests and medical devices for approval. The FDA almost always follows the recommendations issued by these advisory panels.
Expert doctors and scientists who are members of these panels are often targeted by pharmaceutical companies which try to exert undue influence on them. Over the years instances of advisory panel members who received lavish treatment from drug companies have tarnished the FDA's reputation.
Last July, the agency had proposed several new guidelines defining the role of outside experts with known ties to drug makers on FDA advisory panels.
The FDA had promised to look at making the whole process transparent and send information on the advisory panels to public groups. Additionally the agency said it would be providing electronic notifications through an FDA advisory committee list and posting on the FDA web site.
Following up on these guidelines, the FDA said yesterday any scientist or physician who has received $50,000 in funds from any drug maker over the last 12 months would be disqualified from advisory panels that evaluate the said company's products.
Scientists or doctors who received less than $50,000 would be allowed to participate in the discussions, but would not be eligible to vote. Prevailing rules automatically disbar experts who have either received $100,000 from drug companies or account for at least 15% of their net worth.
F.D.A. acting deputy commissioner, Randall W. Lutter said a “significant number” of the current advisers on FDA panels would be affected by this rule. “The $50,000 threshold is something that we think strikes an appropriate balance," he said. "We are committed to making the process even stronger and better-understood."
The situation as regards influential experts on advisory panels had invited Congressional ire as well. Last April a Government Accountability Office report suggested FDA was doing an inadequate job in ensuring the safety of drugs it approved.
The report said this inadequacy was clearly visible in the way the agency handled safety issues concerning the cholesterol-lowering drug Baycol, the painkiller Bextra, the rheumatoid arthritis drug Arava, and the heartburn drug Propulsid.
The New York Times cited the example of how money influenced 10 of the 32 advisers on FDA panels voted to allow Bextra to remain on the market and recommended re-inclusion of Merck's painkiller Vioxx. It emerged later the drug companies had paid these advisers to vote for them. But it must be noted that Vioxx and Bextra continue to be barred from the market.
Dr Lutter said the agency was committed to making the advisory committee process more rigorous and transparent, "Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process," he added.
The guidelines are also the first major changes made FDA Commissioner by Dr. Andrew C. von Eschenbach since he was confirmed last year.
Reactions to the new guidelines were mixed. Representative Maurice D. Hinchey, Democrat of New York said it was high time the FDA cleaned up its act, “So many lives have been lost as a result of the failure of the F.D.A. to review drugs properly,” he said. “The F.D.A. is now moving back to where it was supposed to be, a principled agency that protects the people.”
Dr. Peter Lurie of Public Citizen, an advocacy group felt the new rules would mean recommendations were based on quality alone, “I think it’s likely to improve the quality of the recommendations, remove the taint of the recommendations and improve the credibility of the recommendations,” Dr. Lurie said.
However Diana Zuckerman, president of the National Research Center for Women & Families was unhappy with the $50,000 threshold, "Think of all the members of Congress who have gotten into trouble for much less," she said. "People do crazy things for a lot less than $50,000 — including people who earn a lot of money."
The new rules are open for public comment for 60 days before being put into effect.
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