AI Deployment at the FDA
Advancing
Dr. Marty Makary made artificial-intelligence deployment a flagship of his FDA tenure. In a March 2026 interview with Healthcare Brew, he said the agency had built roughly 150 to 181 AI tools — for document processing, review triage, safety-signal detection, and agentic reviewer assistants — with 181 internal submissions under review, as part of a drive to make drug approval more efficient.
Makary’s stated reasoning was that AI could clear bureaucratic bottlenecks and let reviewers focus on scientific judgment. The reporting also noted pushback: some agency staff, speaking anonymously, criticized the quality of the tools, raising questions about whether speed was being prioritized over reliability.
Makary left office on May 12, 2026. The AI tools built under his tenure remain inside the agency, but whether they will be expanded, maintained, or quietly wound down under acting commissioner Kyle Diamantas or nominee Heidi Overton is unresolved.
Timeline
- 2025–2026: Makary makes AI deployment a flagship FDA project; tools built for document processing, review triage, safety-signal detection, and agentic reviewer assistance.
- March 2026: In a Healthcare Brew interview, Makary says the FDA has built roughly 150–181 AI tools, with 181 internal submissions under review; some staff anonymously criticize tool quality.
- May 12, 2026: Makary resigns; the future of the AI program under new leadership is uncertain.
