FDA’s Hasty Rollout of Agency-Wide AI Tool Faces Significant Challenges

FDA staff have criticized the new AI tool, Elsa, developed with Deloitte and based on Anthropic’s Claude LLM. Staffers described the tool as “rushed,” highlighting that its capabilities have been overstated by officials, including Dr. Peter Makary and the Department of Government Efficiency (DOGE) led by Elon Musk. They asserted that Elsa should only be used for administrative tasks rather than scientific ones and criticized the FDA for lacking proper regulations for its usage. Concerns were raised about the rush to deploy the tool without sufficient policy considerations. Previously, different FDA centers worked on separate AI pilots; however, after budget cuts, the CDER-GPT pilot was chosen for broader implementation as Elsa. Staff from the Center for Devices and Radiological Health reported that their pilot, CDRH-GPT, is plagued with technical issues, highlighting potential challenges in transitioning to a unified AI system across the FDA.

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