Resources for Food and Drug Administration (FDA)

FDA Issues Stronger Rules on Advisory Committee Conflicts of Interest

www.medpagetoday.com

The FDA announced tougher conflict-of-interest rules today for members of its independent advisory committees and changed the way they will vote yea or nay to recommend approval of a drug or device.

The agency said that advisers would not be allowed to participate on a committee if they or a minor child or spouse own a conflicting financial interest worth more than $50,000 -- half the old automatic exclusion level.

Previously, potential advisory committee members were screened to determine whether they had a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee's recommendations.

Those with investments exceeding $100,000 in a company likely to be affected by the meeting outcome or those whose investments exceed 15% of their net worth were automatically excluded. A lower level of investment conflict was permitted but a waiver was needed.

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