US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

 
• By Sarah Karlin-Smith
  
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CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

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CDER Director Cavazzoni wants to weed out emotions from advisory committee outcomes. • Source: Italy stock images / Alamy Stock Photo

Just a few weeks before the US Food and Drug Administration would make the most controversial drug decision in years by approving Biogen, Inc.’s Aduhelm for Alzheimer’s – a decision many critics would argue was based more on the desire to give desperate patients hope than a true scientific advancement – newly appointed Center for Drug Evaluation and Research Director Patrizia Cavazzoni made a strong push to get emotion out of its advisory committee meetings.

“I think that we need to partner with industry on this, and I’m going to maybe say something that may...

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