The FDA has appointed its first chief artificial intelligence officer, with an eye on supporting the agency’s internal IT systems and potentially accelerating its reviews of medical products.
Jeremy Walsh was named head of IT and AI, according to his post on LinkedIn. The move was first reported by Politico. Walsh previously held the role of chief technologist at Booz Allen Hamilton, managing AI- and cloud-based projects for 14 years at the consultancy.
He joins the agency amid a push from its new commissioner, Martin Makary, to speed up the drug review process. In a post on X this week related to the annual meeting of the American Hospital Association, Makary asked, “Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things?”
“We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning,” he added.
Meanwhile, Wired reported this week that FDA officials have been holding early talks with ChatGPT developer OpenAI, led by Walsh, to build an AI program for the agency’s drug reviewers—an offshoot dubbed cderGPT, after the FDA’s Center for Drug Evaluation and Research.
The FDA also announced Thursday that it plans to roll out generative AI programs to reviewers at all three of the agency's centers by the end of June, with the goal of reducing "the amount of non-productive busywork that has historically consumed much of the review process," Makary said in a statement. "I was blown away by the success of our first AI-assisted scientific review pilot."
“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking," he said. "It is time to take action.”
The agency said that by June 30, all centers will be using a single, secure generative AI program integrated with the FDA’s internal data platforms.
“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 Liu, deputy director of CDER's Office of Drug Evaluation Sciences.
The FDA previously consolidated CDER’s AI activities under a single council during the Biden administration, including representatives from all of the center’s offices while replacing its once-separate AI steering committee and policy groups.
The council was tasked with overseeing how AI is employed by drugmakers within its R&D and regulatory submissions, as well as with exploring how AI programs could be used internally by the agency’s reviewers.
During the major restructuring of the FDA in early April, Vid Desai, the FDA’s chief information officer and head of its Office of Digital Transformation, was laid off along with other senior members of the agency’s IT team.
Editor's note: This story has been updated with the FDA's announcement of its generative AI pilot and expansion.