On August 4, 2008, the Food and Drug Administration (FDA) released a series of final guidance documents designed strengthen its management of FDA advisory committees. Among other things, the new policies include stricter limits on financial conflicts of interest for committee members (including a $50,000 cap on the personal financial interest an advisor may have in all companies potentially affected by a meeting), revised voting procedures, strengthened processes for disclosing information regarding advisory committee members’ financial interest information; and procedures for developing and distributing briefing materials considered at advisory committee meetings. The FDA also released draft guidance regarding factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration. Notices regarding the guidance documents also were published in the Federal Register.
