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FDA Puts $50,000 Cap on Conflicts in Advisory Hearings

blogs.wsj.com

The FDA has finalized some new rules of the road for its committees of expert advisers to bolster the public’s confidence in their advice.

A significant thrust is a clampdown on conflicts. The new rules bar the participation of an expert, if that person, their spouse or minor child has conflicting financial interests of more than $50,000.

Until now, the FDA has screened committee members for conflicts of interests and sometimes granted waivers allowing them to participate despite such conflicts. Under the new rules, there generally won’t be waivers for conflicts above $50,000, and waivers for smaller conflicts will be allowed only if the FDA determines “there is an essential need for the adviser’s particular expertise.” The FDA said it wants to cut down on waivers, though, and certain ones will never be allowed — for instance if the expert is principal investigator of clinical trial of product that the committee will consider.

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