On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a New FDA.” It is their view that in the past, the FDA has been reactionary, and that going forward, the FDA will focus on being proactive by rapidly allowing new products to be brought to market if they have “transformational potential.”
Going forward, the FDA is going to prioritize:
- Increasing the speed at which research can be done by minimizing administrative burdens and becoming a “user-friendly FDA that partners with industry…”;
- Implementing generative AI technology at the FDA to assist with application review, and the use of AI-based computational modeling to reduce the need for animal testing;
- Harnessing large amounts of available data to accelerate research into the causes of disease, and for the post-approval monitoring of new products;
- Using the FDAs power to address the cost of drug treatment in the United States; and,
- Refocusing the FDA on food and its potential role as the root cause of chronic disease in the United States.
Dr. Makary and Dr. Prasad state that “…the FDA will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children, and common-sense approaches to rebuild the public trust. The FDA and our great medical profession should unite to consider fresh new approaches to the evolving health topics facing the US today.”