US FDA presents draft revised guidance on transparency and advisory committees

Draft guidance that would expand transparency and disclosure when the US Food and Drug Administration grants a conflict of interest waiver to permit an individual's participation at an FDA advisory committee meeting was revealed yesterday in an agency web site posting.

The draft guidance would expand the information disclosed about waivers prior to committee meetings. Specifically, the FDA proposes to post on-line 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, the agency noted.