Contributed by Kimberly K. Egan
FDA advisory committees "provide independent expert advice to the agency on scientific, technical, and policy matters related to the development and evaluation of FDA-approved products." For each advisory committee, FDA must comply with several existing statutes and regulations laws governing conflicts of interests, not all of which are entirely consistent. See, e.g., 21 U.S.C. § 355(n) (containing the general rules for advisory committees on clinical investigations or marketing approval); 18 U.S.C. § 208 (containing conflicts rules for government employees); 5 C.F.R. § 2640 (containing regulatory exemptions for conflicts of interest rules).
Recently, the FDA issued draft guidance outlining a new 6-step process for determining whether a government employee possesses a conflict of interest that disqualifies her from serving on an advisory committee.