FDA Commissioner Marty Makary Resigns After Year of Turmoil

Food and Drug Administration Commissioner Marty Makary resigned Tuesday, ending a 13-month tenure marked by mass staff departures, clashes with the White House over flavored e-cigarettes, and sustained pressure from anti-abortion groups over the agency’s handling of the prescription abortion pill mifepristone. Kyle Diamantas, the FDA’s deputy commissioner for food, was immediately named acting head of the agency.

Makary — a Johns Hopkins surgeon and longtime critic of the FDA’s pace of innovation before joining the administration — was the fourth high-profile Trump administration official to resign this year. His departure came days after White House staff signed off on a plan to replace him, according to multiple people familiar with the decision. Health and Human Services Secretary Robert F. Kennedy Jr. ultimately made the call.

The Vaping Dispute That Ended His Tenure

The immediate trigger for Makary’s exit was a fight over flavored e-cigarettes. On May 6, the FDA approved a line of fruit-flavored e-cigarettes from the company Glas Inc. — a significant reversal of the agency’s longstanding resistance to such products, which public health advocates argue are designed to attract teenagers.

Multiple sources familiar with the situation told CBS News that Makary opposed the approval but was pressured by the White House and other administration officials to authorize it. The Wall Street Journal reported that President Donald Trump personally pushed Makary on the decision. When the approval went through over Makary’s objections, it set in motion the sequence of events that ended his tenure.

The White House had grown increasingly impatient with what it viewed as Makary’s slow movement on Trump’s regulatory priorities. His resistance to the vaping approval proved to be the final pressure point. The e-cigarette industry — which had long lobbied for expanded flavored-product authorizations — had complained about the FDA’s review pace under Makary, while health groups argued the agency was moving in the wrong direction.

Caught Between Abortion Pill Factions

Mifepristone — the most commonly used method of medication abortion in the United States, approved by the FDA in 2000 — became a second and politically charged front in the pressures on Makary, this time from the right. Susan B. Anthony Pro-Life America, among the most influential anti-abortion organizations in Washington, publicly called for Makary’s removal over the FDA’s handling of the drug.

The group’s complaint centered on Makary’s failure to impose tighter restrictions on mifepristone. HHS Secretary Kennedy had requested a complete safety review of the pill, and Makary launched that review in September 2025. But despite pressure from within HHS to accelerate, the review moved slowly. Administration officials told the New York Times that completion would be pushed to late 2026 — after the midterm elections — a timeline that pro-life groups took as evidence of deliberate delay.

The FDA’s regulatory posture on mifepristone was already under external legal pressure. A federal appeals court blocked mail-order dispensing of mifepristone in all 50 states as recently as early May, with drugmakers filing emergency Supreme Court appeals the following day. The safety review’s fate under Diamantas now adds another layer of uncertainty for the patients, providers, and advocacy groups tracking the drug’s regulatory future.

A Staff Stripped to the Foundation

Beyond the specific policy fights, Makary’s tenure produced a broader collapse of FDA institutional capacity that the biomedical industry had warned about since shortly after he took office.

Senior career officials at every level of the agency left in waves throughout 2025 and into 2026 — through a combination of administration-directed layoffs, early retirements, and resignations driven by disagreements with leadership. The most visible and consequential departure was Dr. Richard Pazdur, the longtime director of the FDA’s Oncology Center of Excellence and one of the most respected cancer drug regulators in the world.

Pazdur, who oversaw the approval of hundreds of cancer therapies over more than two decades at the agency, announced his retirement just three weeks after Makary took office in late March 2025. He cited Makary’s plans to radically accelerate drug review timelines as incompatible with the rigorous evaluation process he had built over his career. After Pazdur’s exit, reporting from BioSpace found that only three veterans remained in the FDA’s senior ranks — a hollowing out that specialists warned would reduce both the speed and quality of the agency’s work.

The pharmaceutical industry’s public complaints about Makary’s FDA were, paradoxically, the opposite of what might be expected from a looser regulatory posture. Specialty drugmakers focused on therapies for rare and hard-to-treat diseases reported receiving rejection letters — or demands to run additional clinical studies — for drugs that had previously received the go-ahead from FDA scientific staff. The inconsistency, they said, made clinical development planning effectively impossible.

That instability makes continuity in specific programs consequential. The FDA’s recent move to open early access to a promising pancreatic cancer drug that nearly doubled survival time in trials came despite the broader institutional churn, but the drug approval pipeline depends heavily on stable expert leadership that Makary’s tenure failed to provide.

Who Is Kyle Diamantas?

Kyle Diamantas brings a legal and regulatory background to the acting commissioner role rather than a clinical or scientific one — a distinction that will matter as the agency faces decisions on drug approvals, the mifepristone review, and the aftermath of the flavored-vape authorization.

Diamantas holds a law degree from the University of Florida Levin College of Law and has spent much of his career working at the intersection of the FDA, HHS, and the White House. He previously served as the FDA’s liaison to both the White House and foreign governments, and has represented the agency in dealings with international regulatory bodies. His immediate background is as deputy commissioner for food, where he led the Human Foods Program overseeing the agency’s nutrition policy and food safety operations — a program that became central to the MAHA (Make America Healthy Again) policy priorities championed by Kennedy.

His elevation immediately prompted public signaling from the groups that had pressured Makary. Pro-life advocates said Tuesday they hoped Diamantas would move more aggressively than his predecessor on mifepristone restrictions. The National Catholic Register noted that Diamantas had previously held a role at Planned Parenthood — a detail circulating quickly in anti-abortion circles as a potential concern, though the specifics of that role were not immediately confirmed.

The FDA’s capacity for landmark science decisions is not contingent solely on leadership. Earlier this year, the agency approved the first gene therapy for genetic deafness — a milestone that demonstrated the agency’s scientific staff can produce significant work even through administrative turbulence. But the pace and consistency of that work depends on the stability that has been in short supply.

What Changes Now

Trump will need to nominate and win Senate confirmation for a permanent FDA commissioner — a process that, under standard conditions, takes several months and requires a formal confirmation hearing before the Senate HELP Committee. Makary himself waited months between nomination and confirmation, and the current state of FDA staffing and policy controversy will guarantee close Senate scrutiny of any nominee.

In the meantime, Diamantas serves as acting commissioner with no fixed end date. Acting commissioners historically have less authority to drive major policy changes than confirmed ones — both because of institutional norms and because major rulemaking often requires a presidentially confirmed official to sign off. The practical question of how far Diamantas will move on the issues that defined Makary’s tenure — vaping, mifepristone, drug approval standards — will become clearer in the weeks ahead.

What is certain is the structural weight of the position. The FDA regulates products that account for roughly one-quarter of every consumer dollar spent in the United States — prescription drugs, medical devices, food safety, cosmetics, dietary supplements, and tobacco products. The agency’s decisions affect every American, and sustained leadership instability at an agency of that scope carries consequences well beyond Washington. The drug development timelines that were disrupted during Makary’s tenure will not be recovered quickly, and the career scientists who left may not return.