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The Food and Drug Amendments Act of 2007 (the FDAAA) added new provisions governing how FDA addresses conflicts of interest for advisory committees. Title VII of the FDAAA, Conflicts of Interest, was effective October 1, 2007, and applies to all FDA advisory committees. The new legislation repeals 21 U.S.C. 355(n)(4), which contained more limited conflict of interest provisions for certain drug and biologics advisory committee meetings.
New section 701 (21 U.S.C. 712) prohibits advisory committee members from participating in FDA advisory committee meetings if the member (or his immediate family member) has a financial interest that could be affected by the meeting outcome. The statute authorizes FDA to grant a waiver of the prohibition if it is necessary to afford the advisory committee essential expertise. The legislation caps the numbers of waivers that FDA may issue in a given year. Among the additional provisions are a requirement that FDA review potential conflicts of interest when considering appointments to advisory committees, public disclosure provisions, and an annual report requirement.