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FDA Tightens Reins on Advisory Committee Process

  Originally Published MDDI August 2006 FROM THE EDITORS   Although the initial focus is on improving the integrity and transparency of drug-related committees, the move will benefit the device industry, too.  

FROM THE EDITORS

The Food and Drug Administration has felt the pressure to ensure that its advisory committees are above reproach. In July, the agency announced steps to “help make its advisory committee processes more effective at providing timely, top-tier, independent scientific advice.” The move is intended to reassure the public about the integrity of the process.

“The advisory process is integral to examining this intersection between medical practice and medical research,” said Scott Gottlieb, MD. Gottlieb, FDA's deputy commissioner for medical and scientific affairs, made his statements in a speech prepared for the Center for Science in the Public Interest in Washington, DC.

FDA wants to ensure that its approaches are rigorous and that it can recruit advisory members through a process that has the quality of scientific input as a top criterion. The agency says it wants a process that is clear and transparent. Moreover, it wants to prevent legislation that might be more stringent and possibly hamper innovation. Over the next few months, the agency will take the following steps:

• 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 conflict-of-interest waivers 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 provide e-mail notifications through an FDA advisory committee Listserv and posting on the FDA Web site.

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

The primary role of an advisory committee is to provide FDA with expert, independent advice on complex scientific issues, so it is essential that the public has confidence in the integrity of those committees.

“It would be a significant step backwards if our primary criterion for selecting members to our committees becomes their lack of private-sector work, if we exclude people for deep experience rather then embrace them for it,” said Gottlieb.

Gottlieb noted that it is impossible for FDA to tell who will eventually have relationships that could present the potential for an appearance of conflict around a specific issue. “If we err and only appoint members who have had absolutely no associations of any kind with any regulated products or industries,” he said, “then we are going to be hard-pressed to find people who have also been engaged in relevant and unique scientific endeavors, since a lot of medical product research today is done in collaboration, at least in part, with sponsors.”

The bottom line is that if industry also keeps an eye on itself, then unnecessary legislation can be avoided.


Sherrie Conroy for the Editors

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