The Food and Drug Administration took a step many consider long-overdue and proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices. The FDA said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.


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The Food and Drug Administration took a step many consider long-overdue and proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices. The FDA said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.
The proposed rules fall short of recommendations made by an Institute of Medicine blue-ribbon panel which advised that a majority of advisory committee members be free of conflicts. Critics of the FDA say these conflicts have led committees to endorse unsafe products.
One example often cited by critics was the 2005 advisory committee vote in favor of allowing Vioxx to return to the market after its manufacturer voluntarily withdrew it. The committee also voted to keep another painkiller, Bextra, on the market. Ten of 32 panel members were later found to have had conflicts of interest, and their votes affected the outcome. The FDA subsequently decided against allowing the sale of Vioxx and asked Bextra’s maker to stop selling its drug.
A study published last year in The Journal of the American Medical Association reviewed advisory panel meetings over three years, and found that more than half of the panel members had a conflict of interest at 22 percent of the meetings surveyed. The study surveyed 221 meetings held by 16 advisory panels from 2001 to 2004. It found that at least one member had a conflict in 73 percent of the meetings.
It is questionable whether the new rules will keep many scientists from participating in the advisory panels as most have financial ties to industry of less than $50,000. But the rules may encourage the FDA to step up its recruitment of scientists who have no industry ties at all.
Since 2000, the FDA has been screening its advisers for conflicts before meetings. Yet that effort only led to further criticism of industry taint, because the agency granted waivers that allowed many scientists to continue participating on the panels, citing the need for their expertise.
FDA officials said the new rules should put an end to those concerns by establishing clear standards for when and how scientists may participate. The agency could also decide to impose additional limits on the participation of experts who meet the new guidelines, if there is a perception of a serious conflict.
The FDA is seeking public comment for the next 60 days.

Categories: Consumer Rights, Health Care, New & Changing Laws
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