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FDA Promises More "Transparency" In Advisory Process

July 24, 2006

• FDA Toughens Advisory Committee Guidelines • Ex-FDA Chief Pleads Guilty to Conflict Of Interest Charges • FDA Promises More Transparency In Advisory Process • Study Finds Conflicts of Interest at FDA • Health Advocates Urge Reform of FDA Advisory Committees • Former Prozac Users Slam FDA • FDA Panel Members Indebted to Drug Companies

Under increasing criticism from consumer groups and tighter scrutiny by Congress, the Food and Drug Administration has offered an explanation of its policy of allowing advisory committee members to maintain their ties to industry. In an announcement, the agency outlined several steps it said would reassure the public about the integrity of the process.

FDA advisory committees offer recommendations about what drugs and medical devices should receive agency approval. The FDA is not required to follow the advice of its committees, but it almost always does.

"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 FDA said in a statement.

The FDA said it is taking these steps to make sure that it has a rigorous review approach while continuing 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."

The FDA said it will take a number of steps in the coming month to create a more transparent advisory process:

• 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.

As the FDA made its announcement, the Center for Science in the Public Interest, a frequent FDA critic, convened a symposium in Washington whether scientists with industry ties should be banned from advisory committees. There is currently legislation pending in Congress that would impose such a ban.

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