Makary, Prasad Outline New Priorities at FDA

Leaders at the Food and Drug Administration outlined their vision for reforming the agency’s role in a JAMA editorial on Tuesday. FDA Commissioner Marty Makary, MD, MPH; and Vinay Prasad, MD, MPH, director of the Center for Biologics Evaluation and Research, cited the growing burden of chronic disease, high drug costs and slow approval timelines as evidence that the current system is failing to meet public health needs.

They proposed several measures to accelerate drug development, including pilot programs for faster regulatory decisions, expanded use of generative AI in application reviews and a shift toward greater use of real-world data over data from traditional trials. Additional priorities include broader use of large-scale data for postmarket surveillance, reducing industry influence in regulatory processes and increasing efforts to lower drug prices.