The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the rollout immediately.
In a bid to support regulatory review, the FDA expects to deploy artificial intelligence across all of its centers by the end of June, the agency announced Thursday.
The announcement comes as the FDA completes its pilot scientific review using a generative AI model. “I was blown away by the success of our first AI-assisted scientific review pilot,” Commissioner Marty Makary said in a statement on Thursday, though the agency did not provide specific details about the project.
Using AI to support its scientific reviewers could help the FDA avert delays in the regulatory process that have started cropping up in recent weeks. Last month, for instance, the FDA missed its target decision dates for Novavax’s COVID-19 vaccine and Stealth BioTherapeutics’ Barth Syndrome drug. The regulator has also yet to release its verdict on GSK’s chronic obstructive pulmonary disease bid for Nucala. Its target action date for that was May 7.
Layoffs at the agency could be to blame. Health and Human Services Secretary Robert F. Kennedy Jr. has enacted a sweeping reorganization of the department, a drastic move that put 3,500 jobs at the FDA on the chopping block. While it is yet unclear how extensively the FDA’s review staff were affected by these layoffs, several former officials and analysts have flagged the possibility that the cuts could lead to regulatory roadblocks and delays.
The move to incorporate generative AI into its review process is a “historic first” for the FDA, the agency claimed on Thursday, one that Makary says will “reduce the amount of non-productive busywork that has historically consumed much of the review process.”
The FDA is moving quickly with its AI rollout “to reflect the urgency of this effort,” as per its Thursday release. All FDA centers have been instructed to start implementing the AI approach immediately, building toward full integration by June 30.
And the FDA isn’t stopping at just integrating AI into decision making. The agency on Thursday also laid out plans to deepen its generative AI capabilities across all centers, with the idea of tailoring AI models to the needs of the relevant center.
In line with its AI push, the FDA recently named Jeremy Walsh as its first-ever head of AI and IT at the agency. Walsh, who made the announcement last week in a LinkedIn post, was previously chief technologist at the tech services and consulting firm Booz Allen Hamilton.
