Conflicts of interest within FDA advisory committee

Conflicts of interest can pose thorny policy dilemmas. KFF Health News highlighted a recent situation in which ten members of a fourteen member committee had received funding from a manufacturer whose product was being considered for patient use. One member received almost $200,000 in funding. While none of the payments were directly related to the medical device in question, outside observers can easily ask whether the advisors can be impartial judges, especially those receiving substantial amounts of funding.

Apparently, FDA considers it a conflict of interest when the committee member has financial interests that "may be impacted" by his or her work on the committee. It also seems that part of the guideline is that if the relationship is more than a year in the past, it does not pose a problem. Those guidelines seem far less strict than what might exist for other industries. At the same time, it does seem difficult to craft guidelines, especially if there are only a few experts in a specific area and if there are only a few large companies and most advisor candidates have received some funding from them. Nevertheless, it seems that at the very least, such appearances of conflict of interest should be clearly disclosed publicly.

Interestingly, the committee member who received the most funding from the manufacturer ended up voting most negatively against the product (relative to other committee members). However, the policy for conflicts of interest should not be crafted based on a single example.