Marty Makary on AI in Regulatory Science: recommends

Dr. Marty Makary recommended agency-wide AI adoption at the FDA — tools for review triage, safety-signal detection, document processing, and agentic reviewer assistants. In a March 2026 Healthcare Brew interview, he said the agency had built roughly 150 to 181 such tools, with 181 internal submissions under review, as part of making drug approval more efficient.

Makary’s stated reasoning is that AI can clear bureaucratic bottlenecks so reviewers can focus on scientific judgment, speeding safe drugs to patients. The same reporting noted that some agency staff, speaking anonymously, criticized the tools’ quality — a counterpoint that belongs in any fair account of the program.

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