The Food and Drug Administration announced new policies aimed at bringing greater transparency to advisory-committee meetings and decisions. The policies are outlined in final-guidance documents that revise advisory-committee voting procedures and provide new steps for handling conflict-of-interest recusals and waivers of committee members. Additional pending guidelines are also detailed in draft guidance that would require the FDA to improve its advisory-committee Web site and clarify the process for convening advisory committees.
Its imperative that we seek advice from independent experts and that we do so in a way that is public, open and transparent, said Randall Lutter, the FDA deputy commissioner for policy. Todays announcement strengthens our processes.
Under the final-guidance rules, the FDA must require committee advisers to recuse themselves from the review process if they have a total financial interest of $50,000 or more in any of the companies that would be affected by a particular committee decision. If a recusal waiver is granted, the agency must post online details of an advisers financial interest and an explanation of why the waiver was granted.
The FDA is also now required to post briefing materials online at least 48 hours before an advisory-committee meeting and to institute a simultaneous-voting process. Advisory committees have previously used a sequential voting process, which may encourage momentum voting and influence the outcome of a decision, according to an FDA news release. -- by Shawn Rhea