Overview

• Elsa was deployed agency-wide on June 2 under FDA Commissioner Marty Makary to speed up drug and device approvals at a reported cost of $12,000 in its first week
• Multiple current and former FDA employees told CNN that Elsa routinely fabricates nonexistent studies and misrepresents real research when used for clinical assessments
• Users say the time saved by Elsa is offset by the extensive fact-checking required to verify its outputs, often making reviews take longer
• FDA AI lead Jeremy Walsh and Commissioner Makary have publicly acknowledged the tool’s tendency to hallucinate but continue to offer its use on a voluntary basis
• With Elsa barred from core review tasks, staff now rely on it primarily for meeting notes and document summaries while the agency develops stronger safeguards