FDA announces plan to strengthen advisory committee processes

FDA announces plan to strengthen advisory committee processes - 25 july 2006 - 13:50 (From Pierre Melquiot)

Under pressure from US Congress, the Food and Drug Administration (FDA) plans to open its decision-making process, by spelling out how and why it grants waivers that allow some outside specialists with potential conflicts to serve as FDA advisers.

Today, the Food and Drug Administration (FDA) is announcing several steps to help make its advisory committee processes more effective at providing timely, top-tier, independent scientific advice to the agency and at reassuring the public about the basic integrity of this process.

FDA announces plan to strengthen advisory committee processes

This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency's advisory committees.

FDA is taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion.

"The advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny," said Dr. Scott Gottlieb, FDA's Deputy Commissioner for Medical and Scientific Affairs. "Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists."

FDA believes it is crucial that the public have complete confidence in the integrity of the advisory committee process. Therefore, in the next few months, the agency plans to take the following steps to help ensure that our advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent : Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities ; Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available ; Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.

Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.

Implementation of a more streamlined approach to the appointment of members to the agency's drug-related advisory committees.

In addition, FDA previously announced that the agency's Center for Drug Evaluation and Research (CDER) is launching an internal assessment of its use and involvement with the advisory committee program of the agency. Led by senior management from the Advisors and Consultants Staff, within CDER, this comprehensive look at current advisory committee practices will include, among other things, the processes for choosing members with expertise specific to the meeting topic, the development of the agenda and questions for the Committee, and the preparation of background materials and presentations for the meeting.

The primary role of an advisory committee is to provide the agency with expert, independent advice on complex scientific issues presented to FDA. This advice contributes to the quality of the agency's regulatory decision-making and strengthens the credibility of the FDA decision-making process by having public discussions of difficult scientific questions by leading experts, the agency staff, and the agency's stakeholders.

FDA remains committed to a transparent and effective advisory committee process to ensure that the Agency and the public continue to benefit from authoritative expert scientific advice.

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