End of a Chaotic Tenure: FDA Commissioner Steps Down After 14 Months
May 14,2026
On May 12, Marty Makary announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), ending a tenure that lasted just under 14 months. Kyle Diamantas, FDA’s Deputy Commissioner for Food Affairs, will serve as Acting Commissioner.
Marty Makary is arguably one of the most controversial commissioners in FDA history. Since his formal appointment by Trump in April 2025, drug approval policies have shifted frequently during his tenure.
He refused to accept Moderna’s flu vaccine application, triggering strong dissatisfaction in the scientific community; on the other hand, he delayed launching a safety review of the abortion drug mifepristone, alienating his traditional Republican supporters. Under his leadership, the FDA also experienced massive personnel turmoil, with frequent turnover of key executives and large-scale layoffs of review staff. These factors have led to unprecedented questions about the FDA’s review efficiency and professional reputation.
Before the resignation was confirmed, rumors emerged last week that Trump had signed a plan to fire Makary. Multiple media outlets reported the news, and Trump had increasingly openly discussed the possibility of dismissing Makary in recent weeks.
On the morning of May 12, Trump posted Makary’s resignation on Truth Social. Speaking to reporters earlier, he described Makary as a “terrific person” and said, “He’ll move on, and he’ll have a great life.”
The Resignation Mystery
In November 2024, Donald Trump announced a series of nominations for leaders of health departments via his social media platforms, including Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) and Marty Makary as Commissioner of the Food and Drug Administration (FDA). At that time, Trump claimed that "the FDA has lost the trust of the American people" and that Makary’s appointment would "correct the agency’s operations."
The appointment itself was full of drama. Robert F. Kennedy Jr. is a prominent anti-vaccine advocate in the United States who has long spread misinformation about vaccine safety. Before becoming FDA Commissioner, Makary was also known for criticizing vaccine mandate policies during the COVID-19 pandemic — as a surgeon, he publicly questioned the requirement for mandatory childhood vaccination, arguing that natural immunity was equally worthy of respect. These views earned him the favor of Trump and his allies.
On April 1, 2025, HHS launched an unprecedented large-scale layoff plan, cutting 10,000 full-time employees. As core institutions of the public health system, the FDA, CDC, and NIH were the hardest hit, with 3,500, 2,400, and 1,200 positions eliminated respectively. The FDA’s layoffs covered key roles such as new drug approval, vaccine research and development, and medical device review, including core leaders like Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER).
Makary took office amid this "bloodbath."
Less than a month after taking office, he appointed Vinay Prasad as Director of the Center for Biologics Evaluation and Research (CBER). Prasad, a hematologist-oncologist, also criticized strict COVID-19 response measures, including vaccine mandates. Another "close ally" of Makary was Tracy Beth Høeg, who shared similar views with Makary on vaccination policies. She joined the FDA as a special assistant in March 2025 and, with Makary’s support, was appointed Acting Director of CDER in December 2025.
These two personnel appointments quickly sparked controversy within the FDA. Critics even pointed out that Makary was not building a professional regulatory team, but rather a "small circle" loyal to his personal beliefs.
Almost immediately after Makary took office, the outgoing CBER Director Peter Marks announced his resignation. Marks had served as CBER Director since 2016 and played a key role in the evaluation and approval of vaccines, blood products, and certain biologics (including cell and gene therapies) in the United States.
In his resignation letter, he directly criticized HHS Secretary Robert F. Kennedy Jr. for spreading misinformation about the safety of FDA-approved vaccines, stating that he could no longer work in an environment where politics took precedence over science.
Marks’ departure was just the beginning. In fact, during Makary’s 14-month tenure, the FDA experienced unprecedented personnel turnover. Coupled with the impact of large-scale layoffs, morale across the agency was extremely low, and internal employees lived in constant fear.
As one of the FDA’s most powerful divisions, CDER is responsible for the approval of new drugs (NDAs), generic drugs (ANDAs), and over-the-counter drugs, and also leads key functions such as post-marketing safety monitoring, label updates, product recalls, and even mandatory market withdrawals. Historically, this position has usually been held by senior officials for long periods of time.
However, during Makary’s more than one-year tenure, CDER changed leaders several times. At the end of 2025, Richard Pazdur, who had long served as the FDA’s oncology chief, resigned just one month after being appointed CDER Director. He lamented the loss of expert voices within the agency and warned that political interference had "seeped into regulatory decisions."
It is reported that Pazdur’s hasty resignation was related to his opposition to the "Commissioner’s National Priority Voucher (CNPV)" program vigorously promoted by Makary — he believed the program was prone to fostering corruption and favoritism.
Another typical example is Vinay Prasad’s two resignations during his tenure. The first was in July 2025, when he publicly resigned after being involved in a high-risk regulatory controversy over Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys, but returned to his post less than two weeks later; the second was at the end of April this year, when he officially stepped down.
In short, within just over a year, the FDA’s original management team was almost completely purged. Frequent personnel changes filled the FDA with unease and uncertainty. And now, this turmoil has finally reached Makary himself.
Caught in the Crossfire
Looking back at Makary’s 14-month tenure, he was caught in the crossfire—pleasing no one and riddled with contradictions. This has sparked profound questions about the FDA’s regulatory professionalism.
One of his most controversial scientific policies was reforming clinical trial requirements. Instead of the standard two trials, he proposed that only one clinical study be required for medical product approval.
One of his most controversial scientific policies was reforming clinical trial requirements. Instead of the standard two trials, he proposed that only one clinical study be required for medical product approval.
Makary stated that while the FDA might still demand two trials in some cases, the default would shift to one. “If well-designed and controlled, a single trial can deliver the same statistical power as two.”
This claim ignited fierce debate in regulatory science. Many experts argue that single trials are prone to chance findings and bias, posing extreme risks—especially for rare diseases or drugs with marginal treatment effects.
Another flashpoint was the Commissioner’s National Priority Voucher (CNPV) program. It slashed review times from the standard 10–12 months to just 1–2 months, but with vague eligibility criteria and a lack of transparency. Who qualified for this “fast-track pass”? What was the decision-making basis? Makary never provided clear answers. Lawmakers and industry observers warned it could become a channel for political interference and favoritism.
During Makary’s tenure, the industry grew weary of constant leadership turnover, inconsistent regulatory standards, and repeated overrides of career scientists’ input.
Discontent extended far beyond the scientific and industrial circles. Though elevated for his conservative health views, Makary was a surgeon with no prior experience in pharmaceutical regulation or public health administration.
Before taking office, he had pledged to restart the safety review of mifepristone (the abortion pill) to restrict its use. Yet once in power, he delayed action—triggering fierce backlash from conservatives and anti-abortion Republicans.
In recent months, Republicans including Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy (R-LA) and Senator Josh Hawley (R-MO) repeatedly urged him to act.
Earlier this month, Marjorie Dannenfelser, president of the prominent anti-abortion group SBA Pro-Life America, called for Makary’s immediate firing. She argued he had failed to prioritize mifepristone’s safety review—a process that could have underpinned efforts to reverse Biden-era rules expanding access to the drug.
Josh Hawley even posted on X: “Dr. Makary has inflicted unique damage on the pro-life movement.”
This resentment simmered until a clash over vaping products likely triggered White House ire.
Trump had campaigned on restoring flavored vape sales. Reports say he sharply criticized Makary for delaying approvals for flavored vapes and nicotine products.
After Trump met directly with R.J. Reynolds representatives and intervened, Makary capitulated. On May 5, the FDA approved the first batch of flavored vapes—but his prior hesitation irked the White House.
While the vaping dispute may have been the immediate trigger for Makary’s resignation, insiders see it as the cumulative result of multiple conflicts.
According to Politico, his boss—HHS Secretary Robert F. Kennedy Jr.—ultimately pushed him out. Kennedy had long been frustrated with Makary and considered curbing his authority.
Makary also reportedly clashed fiercely with HHS Chief Advisor and Medicare Director Chris Klomp over personnel decisions. When patience ran out, Makary’s departure became inevitable.
Handoff in Haste, Unfilled Gaps
While rumors of Marty Makary’s ouster swirled last week, he maintained a full schedule of public events through Tuesday morning and was still cited in FDA press releases.
FDA staff described business as usual for the leadership team, as if nothing was amiss in the commissioner’s office. Yet this veneer of calm masked intense internal turmoil—a stark contrast that underscores how the FDA has become a frontline of White House political warfare over the past year.
Makary was set to testify before the Senate Appropriations Committee on Wednesday regarding the FDA’s fiscal year 2027 budget request. His proposal included legislative initiatives such as creating a fast-track pathway for first-in-human clinical trials for drug developers. These policies, along with the CNPV and the “Trusted Framework,” enjoyed Trump administration support and are likely to persist regardless of his successor—the White House remains committed to accelerating approvals and reducing so-called bureaucratic barriers.
Following Makary’s abrupt resignation, Kyle Diamantas, FDA’s Deputy Commissioner for Food, will serve as acting commissioner.
Diamantas joined the FDA in February 2025 to head the food division. Previously, he worked as a corporate attorney at Jones Day and Baker Donelson. Notably, he lacks a medical background, with expertise spanning regulatory compliance, investigations, enforcement, rulemaking, and legislation. He also represented Abbott Laboratories in infant formula recall litigation.
Given that FDA commissioners typically hold medical degrees, Diamantas is unlikely to be appointed permanently; he will most likely serve as a caretaker during the transition.
Sources indicate the White House is considering potential nominees, including former FDA Commissioner and MD Anderson Cancer Center Chief Medical Officer Stephen Hahn, and former Acting FDA Commissioner and Assistant Secretary for Health Brett Giroir. Both are traditional regulatory candidates with extensive medical and public health management experience.
However, some analysts argue that if Trump pursues disruptive changes at the FDA, he may still select a candidate aligned with Makary’s ideology but with stronger execution and greater obedience.
Makary’s departure leaves a deep leadership vacuum extending far beyond the commissioner’s office.
Vinay Prasad’s exit left the CBER director role vacant, now filled by Katherine Szarama on an acting basis. At CDER, Tracy Beth Høeg—an ally of Makary—took over after Richard Pazdur’s resignation. Whether these Makary-appointed officials will remain is now uncertain.
Key roles, including FDA’s vaccine regulation chief, also remain unfilled, as do the CDC director and Surgeon General positions, which have been vacant for some time.
Further shakeups or restructurings at the FDA are expected in the coming weeks and months. The agency, once the global gold standard for drug review, now stands at an uncertain crossroads.
Whoever becomes the next commissioner must answer a fundamental question: Should FDA regulatory decisions be based on scientific evidence or political ideology? Over the past 14 months, the line has blurred. For pharmaceutical companies, physicians, and patients, the only option is to wait and see amid the turmoil, hoping for clarity.
参考文章：
1、Makary’s time atop FDA over, Diamantas named acting commissioner；politico
2、FDA Commissioner Marty Makary to resign, capping turbulent tenure；Fierce Pharma
3、FDA局长，危矣
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