FDA Draft Guidance Targets Conflicts of Interest

Experts who advise FDA on the approval of a medical device or drug could soon be facing much tougher rules. In efforts to further limit conflicts of interest, FDA's new draft guidance proposes stringent guidelines for advisory committee members and those who want to participate in meetings regarding the approval of a device or drug. Potential participants will no longer be able to advise on a product if they have related financial interests exceeding $50,000. These include interests in the company whose product is being discussed or one of its competitors. A person who has interests $50,000 or less can apply for an exemption, but he or she won't be allowed to vote. Comments on the draft will be accepted for the next 60 days.