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Study assesses relationship between conflicts of interest and voting patterns at FDA meetings

ug Advisory Committee meetings listed on the FDA website.

"A total of 221 meetings held by 16 advisory committees were included in the study. In 73 percent of the meetings, at least one advisory committee member or voting consultant disclosed a conflict; only one percent of advisory committee members were recused," the authors found. "For advisory committee members (n = 1,957) and voting consultants combined (n = 990), 28 percent (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over $10,000, 23 percent of contracts/grants exceeded $100,000, and 30 percent of investments were over $25,000." Additionally, the authors state: "In all three conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of the meetings, but this would not have changed whether the majority favored or opposed the drug."

"Ideally, all panels of scientific experts advising a federal decision making body would be free of financial conflicts of interest with the affected companies," the authors write. "Certainly, advisory committee members who have conflicts of interest with higher dollar values should not be allowed to participate. For advisory committee members with smaller conflicts of interest, full transparency, including disclosure several days before the meeting, is necessary to allow the objective evaluation of committee decisions," the authors conclude.


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Contact: Robert Yule
202-588-7703
JAMA and Archives Journals
25-Apr-2006


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