FDA announces draft guidance expanding transparency, disclosure in conflict of interest waivers

FDA Announces Draft Revised Guidance on Transparency and Advisory CommitteesProposed guidance would expand disclosure, transparency in conflict of interest waivers

The U.S. Food and Drug Administration today announced draft guidance that would expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual's participation at an FDA advisory committee meeting.

The draft guidance would expand the information disclosed about waivers prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest.

Scientific advisory committees provide expert advice on significant scientific, technical, and policy matters to assist in the FDA's mission to protect and promote the public health. The committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, including regulations and guidance.

At times, the FDA believes it is appropriate to seek advice from experts who are top authorities in specific areas and who may have conflicts of interest.

"In my view, it is clearly better for the agency in fulfilling its public health mission when advisors have no conflicts of interest," FDA Commissioner Margaret A. Hamburg, M.D. said in a letter to senior agency officials concerning the proposed guidance. "FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest. At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest."

In her letter, Hamburg listed three steps, consistent with existing agency policy, to minimize concerns when needed experts may have a conflict of interest

1. Consideration of the nature of the conflict of interest, recognizing that not all conflicts are created equal. For example, an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly.
2. Consideration of the type of advice to be provided by the advisory committee. A waiver may be more appropriate for a meeting about a policy issue affecting a class of entities or products than for a meeting focusing on approval of a specific product.
3. Justification of waiver recommendations with a description of the search for equally expert advisors without conflicts and an explanation of why the individual's participation is needed to afford the advisory committee essential expertise.

For more information:

• Draft Revised Guidance on Transparency and Advisory Committee (PDF - 59KB)
• Commissioner Hamburg's Letter to senior FDA officials on proposed guidance
• Additional Advisory Committee Guidance Documents