When is a point of view a conflict of interest?

The US Food and Drug Administration has a longstanding policy on financial conflicts of interest for members of advisory committees involved in authorizing new drugs or medical products. But this year, for the first time, the agency is establishing guidelines regarding “appearance issues,” which include identification of intellectual conflicts.1 In a draft guidance issued in June and open for public consultation until 26 November, the FDA describes the characteristics of advisory committee members and situations that could create the appearance of a conflict or the perception that a committee member “lacks impartiality.”1 2 3

In a brief section of the proposed new guidance, much of which focuses on financial conflicts of interest, the agency cites federal regulations indicating that individuals may be excluded from voting or even participating in hearings on new products if their “impartiality is likely to be questioned” by a “reasonable” person.

This concept, say critics, is ill defined and ill conceived; furthermore, the FDA has already used it in a biased manner that protects commercial interests over the public interest.