FDA's Elsa AI tool fabricates research studies
The FDA's Elsa AI tool, unveiled to accelerate drug approvals, reportedly hallucinates and misrepresents research studies according to current FDA employees. The tool cannot reliably support critical drug review work due to access limitations and the need for staff to extensively verify its outputs.
What happened
The FDA's Elsa AI tool, intended to speed up drug and medical device approvals, has hallucinated and misrepresented research, according to three current FDA employees and documents reviewed by CNN.
The tool generates useful outputs like meeting notes and email templates, but cannot reliably assist with critical review work because it lacks access to industry submissions and company-specific information.
Reported impact
FDA employees report wasting extra time and requiring heightened vigilance to verify whether studies cited by Elsa actually exist or have been correctly represented.
Classification
Sources and evidence
This record was researched and written by the Index, based on the following original reporting.