New FDA AI Tool, Pushed by DOGE and Trump, Isn’t Going Well
June 6th, 2025 // 3:33 pm @ jmpickett
Under pressure from the Trump Administration, FDA rolled out its artificial intelligence (AI) tool this week ahead of schedule, despite a 4% budget cut for FY 2025. The large language model (LLM) named Elsa, which was billed as a tool for FDA workers, is being criticized as buggy, overhyped, and inaccurate.
An NBC report yesterday stated that Elsa should have stayed in development longer. FDA scientists tested Elsa this week with inquiries about FDA-approved drugs and other publicly released information. They found that the AI tool offered inaccurate summaries.
FDA scientists were quoted in the NBC report as calling the AI tool ‘rushed’ and that its abilities were overhyped by FDA senior management. They said in its current form, Elsa should only be used for basic administrative work. One employee said that the controversial Elon Musk’s Department of Government Efficiency (DOGE) and FDA Commissioner Marty Makary ‘think they can supplant FDA staff and slash review times, but they can’t.’ The FDA scientist said that the agency hadn’t set up guardrails for safe use.
Elsa was created based on Anthropic’s Claude LLM and was developed by Deloitte. In the last five years, Deloitte was compensated $14 million to crate the original FDA document database that Elsa’s training was based on. In spring 2025, Deliotte was given a $15 million contract to build the AI tool across FDA’s departments. FDA stated that Elsa was created in a secure GovCloud environment, offering a secure platform for FDAers to review internal documents, while making sure all documents stay inside FDA.
In the past, every FDA center was developing its own AI tool. But after DOGE slashed expenses in May, the AI pilot being developed by CDER was chosen to be developed into an FDA-wide system. It was named Elsa.
CDRH staffers also say that their AI tool, called CDRH-GPT, isn’t functional. It isn’t fully connected to the Internet or the internal systems at FDA. It also has problems with document uploads and allowing FDA employees to ask questions.
