FDA to regulate advisors' financial ties to drug makers
www.chinaview.cn 2006-07-24 16:32:24

The U.S. Food and Drug Administration (FDA) announced Monday that it plans to specify in its new guidelines the kind of industry ties permitted for the outside scientists and doctors serving on its advisory board.     BEIJING, July 24 (Xinhuanet) -- The U.S. Food and Drug Administration (FDA) announced Monday that it plans to specify in its new guidelines the kind of industry ties permitted for the outside scientists and doctors serving on its advisory board.

    According to Bloomberg report, the FDA is considering to make advisory committee members' financial situation more transparent to the public. The advisory board has the power to make recommendations to the FDA on permitting drugs and medical devices to go on market, thus its votes can have enormous influence on drug company stock prices.

    The FDA has long been criticized for appointing doctors and scientists who have such deep financial ties to drug makers that their advice is tainted. The U.S. House has approved legislation that seeks to prevent the FDA from allowing those with conflicts to serve on advisory board.

    The new guidelines, which are being debated internally and will have to go through a public comment period, are an effort to codify how the FDA grants “waivers,” which allow experts with financial ties to drug makers to serve on the boards.

    FDA officials said the rules would make it all but impossible for experts who get money from drug makers’ marketing departments to serve on advisory committees. That would exclude, for instance, anyone who is paid by the marketing departments to promote drugs.

    But the rules would loosen other restrictions, they said. Experts whose ties to a drug maker involve only a grant made to their university may not need to get a waiver, they said.

    Indeed, agency officials said they had no intention of excluding all advisers with ties to drug makers.

    “There are very few academic experts engaged in research who don’t have some ties to industry,” said Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs at the FDA.

    Gottlieb told reporters that he plans to say in remarks at a panel discussion in Washington that the House legislation would create problems for the FDA. In a draft of his speech, Gottlieb says the measure might hamper the agency's ability to "put experience and expertise as the paramount criteria when recruiting members to serve on these committees."

    However, critics contend that the agency must do a better job of keeping its advisory boards free from the drug industry’s financial influence, and studies show that conflicts of interests do exist.

    A study published in the April 26 Journal of the American Medical Association found that 28 percent of advisory board members and consultants had a financial link to either a drugmaker whose product was being considered or a competitor. The most common ties were payments for consulting, grants or investments, according to the study by Public Citizen, a Washington-based group that is critical of the FDA's oversight.

    A February 2005 analysis by the Center for Science in the Public Interest, another Washington-based group critical of the FDA, found that 10 of 32 advisory panelists considering the safety of a class of pain medications similar to Merck & Co.'s withdrawn Vioxx had financial ties to the drugs' makers.

    Had those panelists been excluded, the advisory committee's recommendation to leave the products on the market would have been reversed, the study found. Enditem


Editor: Yang Lei
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