- On June 10, 2025, FDA Commissioner Marty Makary and FDA CBER Director published an article in JAMA that listed their “priorities for a new FDA.” These priorities included accelerating drug development, using AI for scientific review, “healthier food for children,” “harnessing big data,” and reducing patient costs.
- The JAMA article pointed to FDA’s “phase-out” of synthetic food dyes as an example of the agency already taking action to address an “increasingly chemically manipulated diet” in the US. As a practical matter, FDA has of yet not taken any regulatory action with respect to synthetic colors (outside of Red No. 3). The article also called attention to a hastily assembled FDA Expert Panel on Talc that occurred on May 20, and stated that FDA had started working to define ultra-processed foods (UPFs).
- The FDA’s prioritization of AI reviews follows the recent launch of its new generative AI tool “Elsa,” which is part of Commissioner Makary’s initiative to use AI throughout the agency by June 30. According to the JAMA article, FDA has already completed its first AI-assisted scientific review. However, the New York Times reported that the new AI tool was far from perfect, as it is limited in the number of characters it can review and sometimes hallucinates and produces false information.
- Separately, Regulatory Focus, an online news publication, reported that Commissioner Makary sent an agency-wide letter to FDA staff on June 11 announcing his plans to “centralize and enhance key operational functions.” This would include consolidating various departments such as human resources, acquisitions, and communications.
Keller and Heckman will continue to monitor FDA regulatory developments.