Amid staff cuts, FDA looks to AI to 'optimise' reviews
FDA Commissioner Dr Marty Makary.
The FDA is moving at breakneck speed to roll out a generative artificial intelligence (AI) tool for speeding up regulatory reviews, announcing its launch nearly a month ahead of the 30th June deadline.
FDA Commissioner Dr Marty Makary said the early launch of the large language model (LLM) AI, called Elsa, also came in under budget, "thanks to the collaboration of our in-house experts" across the FDA's centres.
It will now be used to help agency employees, "from scientific reviewers to investigators, "work more efficiently on tasks including clinical protocol reviews, scientific evaluations, and selecting targets for inspection.
The launch comes after sweeping job losses at the FDA have raised concerns about its ability to meet deadlines on regulatory reviews. Around 3,500 positions at the FDA had been terminated as of 1st April, which, according to researchers at non-partisan research group Brookings, has compounded long-term inadequate staffing at the agency and will affect its ability to carry out critical inspections – particularly of generic drugs and active pharmaceutical ingredients made overseas.
Makary made no mention of FDA resourcing in his introduction to Elsa, simply trumpeting its capabilities by saying: "One scientific reviewer told me what took 2–3 days now takes 6 minutes."
He added: "Some of the other ways the staff have already told me how they love using the AI tool include summarising adverse events to support safety profile assessments, conducting expedited label comparisons, and generating code to facilitate the development of databases for nonclinical applications."
However, FDA staffers told STAT that they were concerned that the rollout of Elsa had been rushed, and that the FDA is "over-inflating" its capabilities whilst failing to introduce "guardrails" to ensure it is secure and fit for purpose, given that generative AI is notoriously error-prone.
Jeremy Walsh, who recently joined the FDA as its first chief AI officer, said Elsa would continue to be refined with new capabilities as the regulator learns how its staffers are using the tool.
"AI is no longer a distant promise but a dynamic force enhancing and optimising the performance and potential of every employee," he asserted.
Makary, meanwhile, sought to allay fears about the security of Elsa, saying: "I want to be clear, all information stays within the agency, and the AI models are not being trained on data submitted by the industry."
He added: "Today's rollout of Elsa will be the first of many initiatives to come as the FDA leverages AI to rapidly transform how we do business to better serve you."
