FDA Launches New AI Tool

The tool is being used in scientific evaluations and clinical reviews, according to the agency.

The Food and Drug Administration on June 2 launched a new artificial intelligence (AI) tool.

FDA officials said Elsa, the tool, will help employees โ€œwork more efficiently.โ€

The agency is utilizing Elsa to speed up clinical protocol reviews and scientific evaluations, as well as to identify targets for inspections.

FDA officials described Elsa as a โ€œlarge language modelโ€“powered AI tool designed to assist with reading, writing, and summarizing.โ€ They said it can summarize adverse events to help with safety profile assessments, compare labels faster than humans, and generate code to help develop databases.

โ€œToday marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,โ€ FDA Chief AI Officer Jeremy Walsh said in a statement.

AI refers to computer systems that perform complex tasks typically performed by humans.

Dr. Marty Makary, the FDAโ€™s commissioner, said in May that the FDA would immediately start using AI and fully integrate it by the end of June.

โ€œFollowing a very successful pilot program with FDAโ€™s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,โ€ Makary said on Monday. โ€œTodayโ€™s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.โ€

Health Secretary Robert F. Kennedy Jr., who leads the Department of Health and Human Services (HHS), the FDAโ€™s parent agency, cheered the development, calling it โ€œa revolution in public healthโ€ in a post on social media platform X.

The FDA recently fired thousands of employees. HHS officials had said they would cut about 3,500 full-time workers but ended up terminating about 2,500 workers, according to a Senate Democrat report.

Makary told a congressional panel during a recent appearance that no scientific reviewers were fired, although some research scientists were among those terminated.

Byย Zachary Stieber

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