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In keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and conflicts of interests, FDA Commissioner Martin A. Makary, M.D., M.P.H., announces a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed. As part of this effort, the agency will prioritize and elevate the role of patients and caregivers, strengthening the voices of their communities.
The FDA uses its advisory committees to obtain independent expert advice and recommendations on scientific, technical, and policy decisions.
“While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” said Commissioner Makary. “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans. In fact, the FDA has a history of being influenced unduly by corporate interests.”
“Public trust in the healthcare-industrial complex is at an all-time low. We need to restore impeccable integrity to the process and avoid potential conflicts of interest,” said Commissioner Makary.
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.
