The U.S. Food and Drug Administration announced draft guidance that it says would expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual’s participation at an FDA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 The draft guidance would expand the information disclosed about waivers prior to committee meetings.

The proposal calls for the agency 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.

FDA Commissioner Margaret Hamburg says at times 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,” writes Hamburg 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 the letter, Hamburg says to minimize concerns when needed experts may have a conflict of interest the agency should consider the nature of the conflict of interest, the type of advice to be provided by the advisory committee, and 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.