FDA’s New Guidelines Limit Conflict of Interest among Advisers

By Alice Carver
14:19, August 6th 2008
39 votes
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FDA on Monday issued final guidelines that seek to limit conflicts of interest among advisory committee members and open their procedures to public examination, the San Francisco Chronicle reported. Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have a personal financial stake of more than $50,000 in a company affected by a matter under discussion, the agency said. Advisers with grants or other financial interests amounting to less than $50,000 may be allowed to attend meetings and vote if their expertise is deemed essential.

The FDA may allow a specialist with a lesser financial interest to participate if there is “an essential need for the adviser’s particular expertise,” the agency said in a statement.

“It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent,” Randall Lutter, a deputy FDA commissioner said Monday.

“Over time, the percentage of people who have these (conflicts) will diminish,” said Wolfe, director of Public Citizen’s Health Research Group, as quoted by the AP. “A lot of it will have to do with how much energy the FDA is willing to expend to find people who don’t have a conflict of interest.”

Drug and device makers often pay lucrative consulting and speaking fees to the advisory committee members, who represent the world’s leading authorities on a particular disease or condition.

Under the guidelines released a year ago, experts with conflicts of up to $50,000 would have been permitted to attend committee meetings, but not to vote. The guidelines also allow FDA in certain cases to prohibit participation on advisory committees by some medical experts, regardless of whether they have more than a $50,000 financial interest.



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