by Brenda Baletti, Ph.D., Childrens Health Defense:
The U.S. Food and Drug Administration (FDA) plans to remove employees of pharmaceutical companies that the agency regulates from its advisory commissions and “elevate” the role of patients and caregivers, Commissioner Marty Makary announced Thursday.
Makary, in a post on X, said that historically the agency has been unduly influenced by industry. Although the FDA should partner with industry to ensure a “user-friendly review process,” he said, “the scientific evaluation of new products should be independent.”
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While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent. https://t.co/Pj58XLwU9j
— Dr. Martin Makary (@DrMakaryFDA) April 17, 2025
Makary announced the news in an interview with SiriusXM’s Megyn Kelly. He said representatives of pharmaceutical companies would be invited to attend meetings in the same way as the rest of the public — they can sit and ask questions.
MAKARY: “Today we are announcing we are removing pharma members from FDA advisory committees … We are going to be inviting pharma companies to send representatives to the advisory committees, but they can sit with the rest of the public and watch and pose questions”
— Chief Nerd (@TheChiefNerd) April 17, 2025
… The FDA said in a press release that the move is intended “to boost public trust in its decisions and improve how its advisory committees operate.”
Exceptions may be made in rare circumstances when a particular expertise is needed or when pharma reps are required by statute to serve on committees, the agency said.
STAT News reported that the FDA Modernization Act of 1997 requires that non-voting industry reps sit on advisory panels, although that rule appears to be limited to only certain panels.
The FDA convenes advisory panels, intended to be comprised of experts in relevant fields, to provide feedback and recommendations on products under review. The agency does not have to accept advisory panels’ recommendations, although it typically does.
The Big Pharma reps on advisory committees don’t vote on committee decisions.
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