FDA Commissioner Martin A. Makary Annouces New Advisory Policy
The policy aims to prioritize independent scientific evaluation and amplify the voices of patients and caregivers.
On April 17, 2025, FDA Commissioner Martin A. Makary announced a new policy to enhance transparency and reduce conflicts of interest in FDA advisory committees. Aligned with the U.S. Department of Health and Human Services’ commitment to “radical transparency,” this directive limits employees of FDA-regulated companies, such as pharmaceutical firms, from serving as official members of these committees, except in rare cases where their expertise is uniquely required and ethics rules are strictly followed. The policy aims to prioritize independent scientific evaluation and amplify the voices of patients and caregivers.
Key Points
Restriction on Industry Employees: Employees of companies regulated by the FDA, like pharmaceutical firms, are generally barred from serving as official members of FDA advisory committees, though they may attend meetings and present views as members of the public.
Exceptions: In rare cases, industry employees with unique scientific expertise may serve, provided they comply with strict ethics requirements.
Role of Advisory Committees: These committees provide independent expert advice on scientific, technical, and policy decisions related to FDA-regulated products.
Focus on Patients and Caregivers: The policy elevates the role of patients and caregivers, strengthening their influence in FDA decision-making processes.
Public Trust: The policy addresses concerns about undue corporate influence, aiming to restore integrity and public confidence in the FDA’s processes.
Conclusion
This policy will benefit patients by fostering greater trust in the FDA’s decision-making process. By minimizing the influence of pharmaceutical companies and other regulated entities on advisory committees, the FDA reduces potential conflicts of interest that could compromise the impartiality of product evaluations. Elevating the voices of patients and caregivers ensures that decisions better reflect the needs and perspectives of those directly affected, ultimately leading to safer and more reliable healthcare outcomes.
Megyn Kelly is joined by FDA Commissioner Dr. Marty Makary to discuss his new policy limiting who can serve as members on FDA advisory committees, his efforts to counter the perception that the FDA has been captured by Big Pharma and other industries, how he learned first-hand about "the swamp," the apolitical work he and RFK are doing, and more.