FDA rolls out AI across all departments, hires new leadership
The U.S. Food and Drug Administration (FDA) is accelerating its adoption of AI technology across the agency, aiming to fully integrate all centers this summer to support medical device and drug approvals.
The FDA added in a statement that the rollout of AI will begin immediately, following the success of a generative AI pilot for scientific reviewers. FDA Commissioner Martin A. Makary, MD, lauded the results, saying they signaled it was “time to take action.”
“I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process,” Makary said in the announcement. “The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”
The initial rollout will be limited. However, the FDA said it will continue to “expand generative AI capabilities—across all centers using a secure, unified platform,” focusing on supporting core tasks with “document integration, and tailoring outputs to center-specific needs,” in a way that’s compliant with data security and privacy laws.
The move comes as Politico reported a new head of artificial intelligence and information technology was hired, with Jeremy Walsh, a former contractor with Booz Allen Hamilton, to take the position. Walsh has worked for 14 years at Booz Allen Hamilton, serving most recently as its chief technologist, in charge of data analytics and cloud infrastructure.
Walsh confirmed the report in a LinkedIn post.
On a potentially related note, Wired reported the FDA is in talks with OpenAI, possibly to support the rollout, with Elon Musk’s Department of Government Efficiency (DOGE) also meeting with representatives from the generative AI company.
Wired cited internal sources with knowledge of the meetings as the basis for its coverage. Details on what was discussed are limited; however, the sources said Walsh was involved, and it pertained to the development of an AI program designed for drug reviews.
“The agency will continue to assess performance, gather user feedback and refine features to support the evolving needs of FDA staff and advance its public health mission. Additional details and updates on the initiative will be shared publicly in June,” the FDA said.
It placed a deadline of June 30 for its centers to be fully integrated with supportive AI.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.