FDA TO ISSUE GUIDANCES ON CONFLICT OF INTEREST
The FDA is taking a more active role in the growing debate over the independence of its advisory committee members in an effort to head off potential legislative action.
The agency announced July 24 it would issue a number of guidances to address public concerns about potential conflicts of interest between advisory committee members and industry. These guidances are intended to "inspire some confidence" in the advisory committee system, said Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs.
Guidances would more clearly identify the conditions under which the FDA will grant conflict-of-interest waivers, specify when waivers will be disclosed to the public and discuss when committee briefing materials will be made publicly available.
The guidance clarifying when the FDA allows waivers should be finished before the end of the year, Gottlieb said.
The agency faces increasing congressional pressure to reform its advisory committee policies. Lawmakers such as Rep. Maurice Hinchey (D-N.Y.) have argued that these committees are filled with members who have industry ties, potentially biasing their recommendations.