Marty Makary’s resignation as commissioner of the Food and Drug Administration creates a much-needed opportunity to reset the critical agency. It’s not an exaggeration to say that developing a more constructive relationship with medical innovators could benefit billions of people.
Makary, an accomplished cancer surgeon at Johns Hopkins, came into office last year promising reforms. He outlined some good ideas, such as using artificial intelligence to accelerate drug trials. In practice, he proved surprisingly fond of bureaucracy while moving the goalposts for drug approvals.
In February, the agency attempted to reject an application for a flu vaccine by Moderna, claiming that the trial design for the shot — for which the agency had previously given its blessing — was not acceptable. Makary initially defended that decision, only to reverse course after heavy criticism.
Similar stories can be told of many treatments for rare diseases whose applications were derailed under Makary’s leadership, including a promising gene therapy for Huntington’s disease. These were more than just typical complaints about FDA red tape. Companies need certainty, and shifting requirements to get approval in the middle of the process discourages up-front investment.
For weeks, Makary reportedly feuded with the White House over its push to approve flavored vapes, which he opposed over fears that the products would appeal to young people. Yet the company that won FDA approval to sell such products is doing so alongside a strict digital age-verification system.
Makary was right to want to keep underage kids from consuming nicotine products, but controlling the electronic cigarette market with heavy-handed bans only created a more dangerous black market.
While Makary demanded intense rigor on vaping and cutting-edge medicines, he took a less evidence-based approach toward vaccines. It was a blatant bid to curry favor with Health Secretary Robert F. Kennedy Jr. and the “Make America Healthy Again” movement.
Makary supported the Trump administration’s efforts last year to restrict people’s access to covid-19 vaccines. He even criticized the advisory panel at the Centers for Disease Control and Prevention that oversees vaccine recommendations as a “kangaroo court where they just rubber-stamp every single vaccine put in front of them.” Kennedy later fired every member of that panel and replaced them with his own anti-vaccine advisers.
Trump named Kyle Diamantas, the FDA’s chief for foods, as acting commissioner. The former Jones Day lawyer, who is friendly with Donald Trump Jr., could push for more heavy regulation of food, another pillar of the MAHA movement. Kennedy remains determined to ban a long list of chemicals and dyes while adding new labeling requirements.
The backlash to Makary is a warning for the next director to tread carefully when telling Americans what they can eat.
Whomever Trump ultimately nominates will need to clear the health committee chaired by Sen. Bill Cassidy (R-Louisiana), a medical doctor who clearly regrets his vote to confirm Kennedy. If Trump taps someone determined to go to war with agribusiness, the pick will face resistance from farm state GOP senators, as well as Cassidy.
In reality, the firms that generate remarkable medical innovations regulated by the FDA generally take a constructive approach to dealing with their counterparts in government. Bureaucrats working with them, rather than against them, protects patients without stifling breakthroughs. Makary’s successor would do well to keep that in mind.
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