JBizNews Desk
President Donald Trump announced Tuesday on Truth Social that Dr. Marty Makary has resigned as commissioner of the U.S. Food and Drug Administration, naming Kyle Diamantas, the agency’s deputy commissioner for food, as acting commissioner. The announcement, issued as Trump prepared to depart for a meeting in China with President Xi Jinping, ended a roughly 13-month tenure that had become one of the most contested at any federal regulator and triggered fresh uncertainty across the pharmaceutical, food, tobacco and medical-device industries that depend on the agency’s decisions.
“I want to thank Dr. Marty Makary for having done a great job at the FDA. So much was accomplished under his leadership,” Trump wrote, adding that Diamantas, “a very talented person, will be put in the Acting position.”
Speaking to reporters earlier in the day, Trump described Makary as “a great guy” who “was having some difficulty,” and said “the deputy is taking over temporarily.”
The Truth Social post included what appeared to be a text message from Makary submitting his resignation, in which the commissioner wrote, “I announced 50 major FDA reforms. Joe Biden’s FDA had none,” and thanked Trump for the chance to serve.
The departure had been telegraphed for days.
The Wall Street Journal reported Friday that Trump had signed off on a plan to remove the commissioner, and senior administration officials confirmed that Health and Human Services Secretary Robert F. Kennedy Jr. made the final call to replace him.
Makary had been scheduled to testify Wednesday before a Senate Appropriations subcommittee on the FDA’s 2027 budget request — a hearing that will now be reframed around the agency’s leadership vacuum rather than its spending plans.
The most immediate flashpoint was tobacco policy.
Makary had resisted internal pressure to authorize fruit-flavored e-cigarettes, citing youth-use data, and the dispute escalated to a direct confrontation with Trump in recent weeks.
Last week the FDA reversed course, issuing the agency’s first-ever authorization of fruit-flavored vape products for adults 21 and over, clearing mango, blueberry and two menthol variants marketed by Los Angeles-based Glas Inc.
A federal health official told NPR the resignation “came down to the fruit-flavored vape issue.”
But the vape clash sat atop a longer list of grievances.
Anti-abortion groups, including Susan B. Anthony Pro-Life America president Marjorie Dannenfelser and Students for Life president Kristan Hawkins, had publicly demanded Makary’s ouster over the agency’s handling of the abortion pill mifepristone, which Makary approved a second generic version of and which Bloomberg News reported he sought to delay reviewing until after the midterm elections.
Pharmaceutical executives, meanwhile, grew frustrated with what industry observers described as regulatory unpredictability — including the agency’s initial refusal to accept Moderna’s mRNA flu-shot application, the second rejection of Replimune’s melanoma therapy, and disputes over uniQure’s Huntington’s gene therapy.
Most of those decisions were overseen by Dr. Vinay Prasad, Makary’s handpicked director of the Center for Biologics Evaluation and Research, who departed the agency at the end of April after his second exit in less than a year.
Internally, the agency saw extraordinary turnover.
Makary’s initial pick to lead the drug review center, Dr. George Tidmarsh, was forced to resign over allegations he used his position to pursue a personal vendetta. His replacement, longtime cancer regulator Dr. Rick Pazdur, retired after three weeks, citing Makary’s leadership. Six people served as director of the agency’s largest division over the course of one year.
Diamantas, an attorney who joined the FDA in early 2025 from law firm Jones Day, has personal ties to Donald Trump Jr. and has served as deputy commissioner for the Human Foods Program, overseeing nutrition and food-safety policy and acting as a liaison between the agency, HHS and the White House.
He holds a juris doctor from the University of Florida’s Levin College of Law.
People familiar with the administration’s deliberations told reporters that former commissioner Dr. Stephen Hahn, who led the agency from 2019 to 2021, and former acting commissioner Dr. Brett Giroir are under consideration for the permanent role, which requires Senate confirmation.
For regulated industries, the transition lands at an awkward moment.
The pharmaceutical industry is negotiating the reauthorization of the Prescription Drug User Fee Act, which sets the fees drugmakers pay to fund FDA reviews. Acting leadership constrains the agency’s ability to commit to durable policy positions on drug approvals, vaccine recommendations, food enforcement and tobacco rules — the four lines of business that account for the bulk of FDA-regulated commerce.
Makary’s departure is the fourth high-profile exit from the Trump administration this year, following Kristi Noem, Pam Bondi and Lori Chavez-DeRemer.
JBizNews Desk
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