FDA Drug Advisory Committee Conflicts of Interest Assessed
Study finds that many committee members have conflicts of considerable financial value
TUESDAY, April 25 (HealthDay News) -- Conflict-of-interest disclosures are common at U.S. Food and Drug Administration (FDA) Drug Advisory Committee meetings and may warrant excluding members who have large financial interests, according to a study in the April 26 issue of the Journal of the American Medical Association.
Peter Lurie, M.D., of the Public Citizen's Health Research Group in Washington, D.C., and colleagues studied data from 221 meetings held by 16 FDA advisory committees between 2001 and 2004.
Almost three-quarters, or 73 percent, of the meetings included at least one advisory committee member or voting consultant who disclosed a conflict, but only 1 percent of advisory committee members were recused. Nineteen percent of consulting arrangements exceeded $10,000, 23 percent of contracts/grants exceeded $100,000 and 30 percent of investments exceeded $25,000. Excluding members with such conflicts would have meant voting margins less favorable to index drugs in question, but it would not have changed the vote outcomes.
"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 conclude. "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."