FDA Hires its First Chief AI Officer, Rolling Out the Technology Across the Agency

The FDA is installing some artificial intelligence, as well as its first Chief AI Officer.

Jeremy Walsh was hired “a few weeks ago” as the AI chief, according to one FDA official, and will coordinate an agency-wide rollout of the technology, along with Sridhar Mantha, a director of the FDA’s Center for Drug Evaluation and Research (CDER).

Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Mantha recently led the Office of Business Informatics in CDER.

“In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers,” said a May 8 FDA announcement.

“I was blown away by the success of our first AI-assisted scientific review pilot,” said Makary. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

Food ingredient reviews also should benefit from the new technology and the new hire, Kyle Diamantas, deputy commissioner of the FDA’s Human Foods Program, said at the May 15 Food Safety Summit.

Generative AI tools allow FDA scientists and subject matter experts to spend less time on tedious, repetitive tasks that often slow down the review process, the agency’s announcement said.

“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, deputy director of the Office of Drug Evaluation Sciences, Office of New Drugs, in CDER.

To reflect the urgency of this effort, Dr. Makary directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking. It is time to take action,” Makary continued. “The opportunity to reduce tasks that once took days to just minutes is too important to delay.”

At a lengthy Sept. 25 public meeting on the subject of post-market reviews of food additives, Kristi Muldoon Jacobs, then director of FDA's office of food additive safety, said: “We acknowledge we're living in an information age, and we are often under a deluge of information of varying reliability, and this is presenting a real challenge to our post-market work.” She noted that the National Institutes of Health publishes between 4,000 and 7,000 new scientific articles each day, most of which should be considered for the post-market review process.