The FDA commissioner lasted thirteen months because the position requires satisfying three constituencies whose demands are mutually exclusive. The pattern is not personnel failure. It is structural impossibility applied to technocratic agencies under transactional governance.
Marty Makary resigned as FDA Commissioner on May 12, thirteen months after taking the oath. Trump posted the resignation text on Truth Social. The departure came one day before Makary was scheduled to testify before the Senate Appropriations Committee on the FDA's budget.
The Three-Way Vise
Makary was caught between three constituencies whose demands cannot be simultaneously satisfied.
The first was the president. On May 5, the FDA authorized four Glas closed-pod e-cigarette products, including Gold and Sapphire, pseudonyms for mango and blueberry flavoring. It was the first time the agency had ever authorized fruit-flavored e-cigarettes. The products use a digital lockout system requiring government ID verification, Bluetooth phone pairing, and biometric check-ins. A federal health official told reporters the departure came down to the fruit-flavored vape issue. Trump wanted faster authorization. Makary wanted the lockout system. They got both, and it was not enough.
The second constituency was the social conservative base. Susan B. Anthony Pro-Life America demanded that Makary revoke Biden-era rules allowing mifepristone to be prescribed online and mailed. The group's president called publicly for Makary to be fired immediately. Instead of revoking the rules, Makary approved a second generic version of mifepristone under his own signature.
The third was his own boss. HHS Secretary Robert F. Kennedy Jr. wanted faster regulatory changes aligned with the Make America Healthy Again movement. Makary approved updated mRNA COVID vaccines, angering the constituency Kennedy had mobilized. The friction between scientific independence and political direction became irreconcilable.
No single person can satisfy all three. The president wants loyalty and speed. Social conservatives want regulatory action on culture-war products. The scientific establishment wants evidence-based decisions on a timeline that serves neither political objective. Every decision that satisfies one constituency alienates another.
The Replacement
Kyle Diamantas became acting commissioner. He holds a law degree from the University of Florida, spent roughly three and a half years at Jones Day, most recently as partner, specializing in food and beverage regulatory compliance, and previously represented Abbott in infant formula recall litigation. His title was Deputy Commissioner for Human Foods. He does not have a medical degree.
The appointment of a food-regulatory lawyer to lead an agency responsible for drug approvals, vaccine oversight, and medical device regulation is not an accident. It signals caretaker mode. No controversial drug decisions are likely for months. The FDA is managing its existing docket, not charting new direction.
Dr. Richard Pazdur, the longtime cancer drug regulator who oversaw decades of oncology approvals, departed and cited Makary's leadership as his reason. The agency has lost approximately 3,500 employees, nineteen percent of its workforce, since April 2025. BioSpace reported the FDA is missing drug review deadlines as the staff exodus compounds.
The Pattern
The FDA joins a sequence. The SEC has operated under acting leadership for extended periods. The CFPB was gutted and then partially reconstituted. Each case follows the same mechanism: a technocratic agency designed to make expert decisions is placed under political leadership that treats expertise as one input among several, alongside loyalty, speed, and constituency management.
The hollowing is not abolition. The agencies continue to exist. Their buildings remain occupied. Their mandates are unchanged. What disappears is the institutional capacity to make decisions that no political actor requested. Abolition would be visible and contestable. Hollowing is gradual and self-reinforcing, because each departure of senior staff makes the remaining decisions more dependent on political direction, which drives further departures.
Winners and Losers
Biotech stocks rose on the news. The Nasdaq Biotechnology Index gained about one percent. Replimune surged more than eight percent after Makary had rejected its melanoma therapy. UniQure rose about five percent after Makary reversed earlier feedback on its Huntington's gene therapy. Bloomberg characterized the reaction as biotech hoping the circus is over.
The market is pricing a faster and looser approval environment. Whether that benefits patients depends on which constraint was binding. If the FDA was too slow, relaxation helps. If the FDA was appropriately cautious, relaxation harms. Both are true simultaneously across different product categories, which is why the three-way vise is structural rather than a matter of finding the right commissioner.
The losers are the career scientists who built the institutional knowledge that drug review depends on. Pazdur's departure alone represents decades of oncology regulatory expertise that cannot be replaced by hiring. The FDA's review capacity is a function of accumulated judgment, not headcount. Refilling positions without the judgment that filled them produces an agency that processes applications without the ability to evaluate them.
If Diamantas approves a controversial drug within sixty days, the caretaker thesis fails. If the next permanent commissioner lasts fewer than thirteen months, the structural impossibility thesis is confirmed. The most likely outcome is that the position remains unfilled long enough for the absence of leadership to become the leadership style.
Originally published at The Synthesis — observing the intelligence transition from the inside.
Top comments (0)