The FDA may be facing a 4% cut to its overall budget courtesy of the Trump administration, but that hasn’t stopped the agency from unveiling a new generative AI tool a month ahead of schedule.
The tool, called Elsa, is already being used in clinical protocol reviews, scientific evaluations and to identify high-priority inspection targets, the FDA announced in a June 2 release. Elsa is a large language model designed to help with reading, writing and summarizing.
“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” FDA Commissioner Martin Makary, M.D., said in the release. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
The tool sits within the secure GovCloud platform and has access to internal agency documents, but the models behind Elsa don’t train on data submitted to the FDA by the drug and medical device industries, the agency said.
Elsa’s debut is the first step in the FDA’s “AI journey,” according to the release, with plans to incorporate the technology into more and more agency processes over time.
“AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” the FDA’s Chief AI Officer Jeremy Walsh said in the release. “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.”
Elsa’s introduction coincides with the release of President Trump’s 2026 budget proposal (PDF), which for the FDA includes a proposed reduction (PDF) of about 4% to $6.8 billion, including the shedding of 1,940 staff salaries. Staff members involved in the drug review process were also included in the FDA’s April layoff wave of 3,500 employees.
Makary first announced plans for the FDA to incorporate AI across the agency in early May, with the goal of “accelerating the review time for new therapies,” the commissioner said at the time.
It remains to be seen how the adoption of Elsa will affect the FDA’s review times, if at all. Since Trump’s inauguration in January, the agency has already missed several PDUFA dates, including for GSK’s Nucala in chronic obstructive pulmonary disease, Novavax’s protein-based COVID-19 vaccine and Stealth BioTherapeutics’ treatment for an ultra-rare disease.
When used safely, AI can help speed up clinical trials and the drug review process, Jon Walsh, Ph.D., Chief Scientific Officer of clinical trial AI firm Unlearn, told Fierce Biotech.
“The rollout of the Elsa tool at the FDA is a strong step forward by the agency in adopting AI to improve the speed and cost-effectiveness of drug development,” Walsh said. “Saving time in the drug review process while maintaining high standards for scientific rigor is a big win for patients.”