Bureaucratic Resistance Forces Out FDA Chief Makary
FDA Commissioner Marty Makary resigns after 13 months as internal agency resistance, industry pressure and ideological battles paralyze his deregulatory agenda at the nation's top health regulator.
Marty Makary left the FDA on Tuesday after a turbulent 13 months defined by one relentless struggle: a deregulatory White House colliding with a risk-averse bureaucracy. The former Johns Hopkins surgeon, hired to slash red tape and speed drug approvals, resigned effective May 12, becoming the latest casualty in the Trump administration's push to dismantle institutional inertia at federal health agencies.
The resignation signals something larger than a personnel change. It marks the latest collision between the administration's aggressive deregulatory mandate and a deeply entrenched FDA culture resistant to reform. Caught between White House demands for faster approvals and an agency that repeatedly stalled changes, Makary found himself paralyzed by internal stonewalling, high executive turnover and conflicting pressure from industry lobbyists and ideological advocates.
The breaking point arrived with flavored vapes. President Trump campaigned on protecting vaping, but internal FDA resistance stalled approvals for months. On May 5, the agency approved four new Glas e-cigarette products, including the first fruit-flavored offerings in blueberry and mango. Makary told confidants his conscience would not allow him to approve vapes with such youth appeal, according to the New York Times, as reported by the Philadelphia Voice.
Chaos inside the FDA's drug center revealed systemic resistance. Six directors served as head of the Center for Drug Evaluation and Research in one year. Dr. Vinay Prasad, Makary's handpicked vaccine chief, was pushed out twice in less than 12 months. Dr. Rick Pazdur announced retirement after just three weeks as drug center director. The FDA initially rejected Moderna's flu vaccine application, then reversed course days later.
Makary's text to Trump highlighted the accomplishments he believed he had secured. "Please accept my resignation, effective today," he wrote in a message to Trump, which Trump shared on Truth Social. "During my tenure, I announced 50 major FDA reforms. Joe Biden's FDA had none. I'm extremely proud that we reduced drug review times from a year to 1-2 months."
The mifepristone standoff exposed Makary to criticism from multiple fronts. Anti-abortion groups pressured him for a safety review of the abortion drug for more than a year. He approved a new generic version in October 2025, drawing conservative ire. Approximately two-thirds of all U.S. abortions now utilize medication.
Sen. Josh Hawley called Makary "uniquely destructive to the prolife movement" on X. "He slow walked a vitally necessary review of the abortion drug mifepristone. He used his discretion to approve a new abortion drug when the data shows it sends 1 in 10 women to the emergency room."
Kyle Diamantas, the FDA's deputy commissioner for food, now serves as acting commissioner. Diamantas is a partner at the Miami law firm Jones Day and an architect of the 2025 Dietary Guidelines for Americans, a policy victory for the Make America Healthy Again coalition. He is reportedly a hunting friend of Donald Trump Jr.
The leadership change leaves a critical vacancy at a pivotal moment for the MAHA agenda. The Health and Human Services department currently operates without a permanent CDC director, surgeon general or FDA commissioner. Makary is the third Senate-confirmed HHS official to depart.
HHS Secretary Robert F. Kennedy Jr. praised Makary on X. "You took on entrenched interests, challenged the status quo, and never lost sight of the American people we serve. You pushed forward critical reforms and helped advance our mission to Make America Healthy Again."
Conservative voices expressed frustration with Makary's approach. Roger Bate of the International Center for Law and Economics told the Washington Examiner that Makary "did not properly serve the MAHA agenda and instead led the agency by substituting his own judgment for a clear policy mandate."
Democrats offered rare praise. Sen. Dick Durbin stated, "He resisted Trump's plan to expose millions of children to the dangers of vaping. I hope Dr. Makary will inspire others within the Trump Administration to grow a spine and put the families of America ahead of blind loyalty to this president."
The administration now faces the immediate need for a permanent nominee while continuing its battle to shift the FDA's culture from risk-aversion to market-driven innovation. Trump told reporters on the White House lawn before departing for China, "Marty is a great guy, he's a friend of mine. He's a wonderful man, and he's going to be off and the assistant, the deputy, is taking over temporarily. He was having some difficulty."