For the past 25 years, I have covered the U.S. Food and Drug Administration. With that experience, I can say without hesitation: Marty Makary was the worst FDA commissioner in that time.
Makary, who resigned under pressure on Tuesday, brought to the role a fundamental misunderstanding of the FDA’s mission, its operational functions, and the needs of its employees. His tenure was marked by excessive turnover in senior leadership, diminished regulatory standards, and a disregard for staff expertise in both science and regulatory strategy.
By the final phase of his leadership, Makary appeared increasingly isolated, fixated on securing symbolic victories that often lacked meaningful impact.
This assessment does not dismiss all of his contributions. Makary advanced several initiatives, including:
- Expanding the use of artificial intelligence in drug development to improve efficiency and accuracy.
- Reducing review delays by cutting unnecessary waiting periods for companies awaiting regulator responses.
- Accelerating clinical trials to bring treatments to market more quickly.
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