FDA Releases Draft Revised Guidance about Conflict-of-Interest Waivers

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ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Last week, the US Food and Drug Administration made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers that the agency grants to allow experts to take part in advisory-committee meetings. Under the draft guidance, FDA would post on its website the name of the company or institution associated with the financial interest and the type of conflict of interest before the committee meeting takes place. The draft guidance would make FDA’s practice more consistent with standard practice in the academic community.

FDA convenes scientific advisory committees to seek expert advice about particular scientific, technical, and policy matters. The committees counsel the agency about specific regulatory decisions such as product approvals and about general policy matters such as regulations and guidance. For advice about particular specialized matters, the agency can consult only a limited pool of experts, some of whom may have conflicts of interest.

In a letter about the draft guidance to senior agency officials, FDA Commissioner Margaret A. Hamburg stated that it is better for the agency to choose advisors who have no conflicts of interest. “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,” she said.

In her letter, Hamburg asked agency officials to take the following three steps to minimize the concerns that arise when experts may have conflicts of interest:


• Consider the nature of the conflict of interest before recommending a waiver because not all conflicts are 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.
• Consider the type of advice to be provided by the advisory committee. A waiver may be more appropriate for a meeting about a policy issue that affects a class of entities or products than for a meeting focusing on the approval of a specific product.
• Justify a waiver recommendation 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.

All waiver requests should be reviewed by the appropriate Center director for consistency with these three principles, said Hamburg in the letter. In the case of Office of Commissioner advisory committees, the review should be conducted by the relevant deputy Commissioner.