Key Takeaways
- The FDA is rolling out artificial intelligence (AI) across all its centers, with a goal of full implementation by June 30, 2025.
- A successful pilot program showed AI can significantly speed up the scientific review process for new therapies.
- This initiative aims to reduce tedious, repetitive tasks, allowing FDA scientists to focus on more complex work.
- The agency-wide AI deployment is a top priority to accelerate the availability of new treatments.
The U.S. Food and Drug Administration (FDA) is taking a significant leap forward, announcing an ambitious plan to integrate artificial intelligence across all its operations. FDA Commissioner Martin A. Makary, M.D., M.P.H., detailed the aggressive timeline following a successful test of generative AI for scientific reviewers, according to a press announcement from the FDA.
Dr. Makary expressed his excitement about the pilot’s outcome, stating, “I was blown away by the success of our first AI-assisted scientific review pilot.” He emphasized the need to value scientists’ time by reducing “non-productive busywork” that has historically bogged down reviews.
The new AI tools are designed to help FDA experts spend less time on repetitive tasks. This shift is expected to free them up for more critical thinking and analysis, ultimately speeding up the review process for new medical treatments.
Highlighting the impact, Jinzhong (Jin) Liu, from the FDA’s Center for Drug Evaluation and Research, said, “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days.”
To underscore the importance of this initiative, Dr. Makary has instructed all FDA centers to begin adopting AI immediately. The goal is full integration by the end of June 2025, establishing a common, secure AI system connected to the FDA’s internal data.
“There have been years of talk about AI capabilities… but we cannot afford to keep talking. It is time to take action,” Dr. Makary urged. He pointed out that the chance to cut tasks from days to minutes is “too important to delay.”
Looking ahead, the FDA plans to continue expanding these AI capabilities. Future improvements will focus on user-friendliness, broader document integration, and tailoring the system to each center’s specific needs, all while maintaining strict security and policy compliance.
This agency-wide rollout is being spearheaded by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, and Sridhar Mantha. Walsh has extensive experience with large-scale technology deployments in federal health, while Mantha previously led business informatics in the drug evaluation center.
The FDA will keep a close eye on performance, gather feedback from users, and refine the AI features. This ongoing effort aims to support FDA staff effectively and further the agency’s mission to protect and promote public health. More details on this initiative are expected to be shared in June.
