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Report: Advisory Committee Conflicts of Interest May Be Unavoidable

November 28, 2007

As part of an ongoing effort at the FDA to bring its advisory committees in line with recommendations from the Institute of Medicine, the agency has released the results of a report on conflicts of interest and announced several changes to how the committees operate.

Eastern Research Group, a consulting firm, conducted a study of 16 recent advisory committees at the FDA’s request and found the median dollar value of financial interest for members receiving waivers was $14,500.

The report states that more experienced advisory committee members were more likely to have received waivers for financial conflicts of interest. However, there was no relationship between a member’s measure of expertise and the total dollar amount for the waiver. Alternate experts can be identified but may not be appropriate or available to serve as committee members and could require waivers as well. Creating advisory committees devoid of conflicts of interest may not be possible and would pose an additional burden on the cost and timeliness of committee operations, the report concludes.

The draft guidance on voting can be seen at www.fda.gov/oc/advisory/votingguidance.html. The report on conflicts of interest is available at www.fda.gov/oc/advisory/ERGCOIreport.pdf.