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FDA asks for public input on advisory committee reforms

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As the FDA considers an overhaul of the advisory committee process, the agency is asking for public input on how the panels are used and how their purpose can be made clearer.

The agency announced plans to hold a public meeting on June 13 to discuss how it can best assemble committees and communicate their purpose to the public, among other topics. FDA Commissioner Robert Califf has hinted at upcoming systemic reforms to the adcomm system and has said he’d like to move away from voting in many scenarios.

“It’s important we have the right expertise, diverse viewpoints and other processes in place to ensure the agency gets timely and sound advice,” Califf said in a statement announcing the session.

In the announcement, the FDA emphasized that while it considers the input from experts on the committees, adcomms are just one of several factors it takes into account when making regulatory decisions. The request for feedback also asks for input on how the agency could adjust the voting and discussion process so its purpose is clearer.

“There appears to be a persistent misconception that advisory committee votes are the final decision of the agency on the matter considered by the committee,” the agency said in the notice.

The FDA also asked stakeholders to share what types of viewpoints they think are particularly important to be represented on an advisory committee, as well as those that aren’t relevant. It also asks for feedback on ways to better represent consumer and patient voices.


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