STAT+: Why Marty Makary was the worst FDA commissioner in 25 years

STAT PlusOpinionMatt’s Take Why Marty Makary was the worst FDA commissioner in 25 years He may not bear all the blame, but he leaves behind a weakened agency Manage alerts for this article Email this article Share this article By Matthew HerperMay 12, 2026 Senior Writer, Medicine, Editorial Director of Events Matthew Herper[email protected]Matthew Herper covers medical innovation — both its promise and its perils. I have covered the FDA for the past 25 years, and so I don’t say this lightly: Marty Makary was the worst commissioner in that time. Makary, who resigned under pressure from the Food and Drug Administration on Tuesday, brought to the job a fundamental lack of understanding of the nature of the role, of the functions of his agency, and of the needs of the employees who worked for him. He allowed too much of the senior leadership of the agency to leave or be removed, weakened its standards, and ignored staffers who understood both the science and the political art of regulation. Toward the end of his tenure, he seemed isolated and obsessed with notching “wins” that often amounted to very little.Advertisement That is not to say he did no good at all: Makary’s efforts to foster the use of artificial intelligence in drug development, to speed the drug review process by reducing dead time as companies wait for responses from reviewers, and to accelerate clinical trials were all strong ideas. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, FDA, Pharmaceuticals, Policy, STAT+ Submit a correction requestReprints Matthew Herper Senior Writer, Medicine, Editorial Director of Events Matthew Herper covers medical innovation — both its promise and its perils. Newsletter All the health and medical news you need today, in one email Recommended Politics May 12, 2026 STAT Plus: Makary departs FDA amid turmoil as Diamantas, agency’s top food official, steps in The Readout May 12, 2026 STAT Plus: Hims’ sales miss as telehealth competition grows Advertisement Biotech May 12, 2026 STAT Plus: Capsida says it still doesn’t know what caused gene therapy death The Readout May 11, 2026 STAT Plus: Astellas treatment offers new hope to a devastated rare disease community Health May 11, 2026 STAT Plus: Five years after disaster, a rare disease community gets new chance at treatment Subscriber Picks