FDA JOINS CONGRESSIONAL DEBATE ON ADVISORY COMMITTEES

The FDA is attempting to place itself in the growing debate over the independence of its advisory committee members and head off potential legislative changes with its announcement of a slate of new guidances.

The agency announced July 24 that it would issue a number of guidances to address public concerns with potential conflicts of interest among advisory committee members. These changes are intended to "inspire some confidence" in the advisory committee system, Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, said.

One guidance would more clearly identify the conditions under which the FDA will grant conflict-of-interest waivers. Other guidances will specify when these waivers will be disclosed to the public and when committee briefing materials will be made publicly available. Details of these guidances were not released.

The guidance clarifying when the FDA allows waivers should be finished before the end of the year, Gottlieb added. The other guidance will take longer because of the need to review the legal and ethical issues involved in releasing conflict data to the public.

The announcement comes as 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.

The issue is nearing resolution as amendments to the House and Senate versions of the agency's appropriations bill recommend changes to the advisory committee system. Hinchey's amendment, which has been approved in the House bill, would prohibit the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels. But the Senate language would only require public notice 15 days before the panel's work begins regarding which advisory committee members have financial ties to drug or device companies.

The agency is aware that changes are likely and wants to ensure that its views prevail, William Vaughan, senior policy analyst for Consumers Union, said. The agency's announcement "seems to be an effort to support the less sweeping language" of the Senate bill by showing that the FDA is taking action, he said.

Gottlieb agreed that pending legislative action is a factor in the agency's decision to announce these initiatives. "We would hope people contemplating legislative proposals" would consider the work the FDA is already doing on this issue, he said.

Wholesale prohibition of experts with industry ties would rob advisory committees of some of the most experienced and knowledgeable members, Gottlieb said during a July 24 speech before the Center for Science in the Public Interest. Using industry ties as the main factor in limiting committee membership would be a "significant step backward," he said. "To those who want to rewrite the rules, and remake that architecture, I would say, mend it, don't end it." (http://www.fdanews.com/did/5_144/)