Members of US Food and Drug Administration advisory committees often have financial ties to the companies whose drugs they are evaluating, but the relationships rarely affect their decisions, according to a new study.
The report, prepared by consumer group Public Citizen and published in the Journal of the American Medical Association, concludes that financial relations between industry and FDA advisors can often be of considerable monetary value, but rarely led to an expert being excluded from the proceedings. Financial ties examined by the study include consulting agreements, research contracts, investments and speaker fees.
But while a weak correlation between these ties and voting behaviour was detected, excluding those advisory committee members from the FDA panel process would not have altered the overall outcome at any meeting studied, according to the report.
Public Citizen conducted its study by analyzing agendas and transcripts from all FDA advisory committee meetings carried out between 2001 and 2004 that were listed on the FDA’s website.
In January 2002, the US Food and Drug Administration issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings. The guidelines automatically remove advisory committee members when they have investments that exceed $100,000 in pharmaceutical companies likely affected by votes on products under consideration at meetings or when such investments account for more than 15% of their net worth.
19% percent of consulting arrangements identified in the study involved over $10 000, 23% of contracts/grants exceeded $100 000, and 30% of investments were over $25 000.
“Conflicts of these magnitudes should result in automatic recusal from advisory committee meetings,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group. “With as many highly qualified professionals as we have in this country, there should be little difficulty identifying members with more limited or, ideally, no conflicts of interest.”