FDA to explain advisers’ outside ties

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The FDA said last week it would take several steps to explain how and why it grants waivers allowing outside specialists with potential conflicts of interest to serve as agency advisers. “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,” the agency said in a statement. Scott Gottlieb, FDA's deputy commissioner for medical and scientific affairs said, “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. 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.” The FDA said it plans to take the following steps in the next few months to help ensure its 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. Additionally, the FDA’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, the examination of 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.

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