FDA Rushed Out Agency-Wide AI Tool

upstart writes:

An agency-wide LLM called Elsa was released weeks ahead of schedule:

Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate.

On Monday, the FDA publicly announced the agency-wide rollout of a large language model (LLM) called Elsa, which is intended to help FDA employees-"from scientific reviewers to investigators." The FDA said the generative AI is already being used to "accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets."

"It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications," the announcement promised.

In a statement, FDA Chief AI Officer Jeremy Walsh trumpeted the rollout, saying: "Today marks the dawn of the AI era at the FDA[. W]ith 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."

Meanwhile, FDA Commissioner Marty Makary highlighted the speed with which the tool was rolled out. "I set an aggressive timeline to scale AI agency-wide by June 30," Makary said. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers."

However, according to a report from NBC News, Elsa could have used some more time in development. FDA staff tested Elsa on Monday with questions about FDA-approved products or other public information, only to find that it provided summaries that were either completely or partially wrong.

FDA staffers who spoke with Stat news, meanwhile, called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government Efficiency (DOGE), which was headed by controversial billionaire Elon Musk. In its current form, it should only be used for administrative tasks, not scientific ones, the staffers said.

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