FDA ADVISORY COMMITTEE PROCESS TO BE REVAMPED TO ADDRESS CONFLICT OF INTEREST ISSUES

The FDA plans to strengthen its processes to ensure the integrity of advisory committee member selection and protect against potential conflicts of interest, the agency said July 24.

The notice comes in the wake of mounting criticism by lawmakers and activists of the agency's advisory committee policies. Critics say too many members of these boards have financial ties to industry, potentially creating conflicts of interest.

In the interest of increasing the transparency of the advisory committee member selection process, the FDA said it intends to:Develop guidances on disclosing waivers of relationships that "could present the appearance of conflicts of interest"; and Implement "more streamlined approaches" to appointing committee members.

The Senate Appropriations Committee June 22 adopted an amendment requiring the FDA to notify the public of which members have conflicts of interest 15 days prior to an advisory meeting. The proposal also requires the agency to submit a semiannual report on its attempts to find advisory committee members with minimal or no conflicts of interest.

The Senate provision differs significantly from the House's proposal, which would prohibit the FDA from issuing a waiver for a voting advisory committee member with a conflict.