FDA Announces Policy Directive Limiting Industry Representatives on Advisory Committees

Ervin Cohen & Jessup LLP
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Ervin Cohen & Jessup LLP

On April 17, 2025, FDA Commissioner Martin Makary announced a policy directive to limit industry representatives, who are employed by companies regulated by FDA from serving as official members on FDA advisory committees. FDA advisory committees have historically been used by FDA to obtain independent expert advice and recommendations on scientific and technical policy decisions.

FDA’s news release states: “Today’s action will not preclude employees of regulated companies from attending or presenting their views at advisory committee meetings or serving as representative members of the committee when required by statute. Also, exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements. By limiting employees of FDA-regulated companies from serving as officials, the FDA aims to boost public trust in its decisions and improve how its advisory committees operate.”

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