FDA's New Drug Approval AI Is Generating Fake Studies: Report

The AI, dubbed Elsa, is supposed to be making employees better at their jobs.

gizmodo.com

FDA’s AI “Elsa” Is Making Stuff Up

HHS chief RFK Jr. has fast-tracked a generative AI tool called Elsa at the FDA, promising quicker drug approvals—but a CNN deep-dive reveals it “hallucinates” fake studies and confidently misrepresents real research. While some staff find it handy for notes and briefs, others warn that anything Elsa spits out without a human fact-check is pure fiction, potentially creating more work (and hazards) than it saves.

Despite FDA boss Marty Makary touting Elsa as “under budget” and “ahead of schedule,” employees tested it on simple queries—only to get confidently wrong answers that require full manual verification. Critics say this highlights a bigger problem: AI can’t replace expert eyes, and until Elsa stops inventing papers, speeding up approvals could mean rolling out drugs based on thin air.