Inside the Fall of FDA Commissioner Marty Makary: Flavored Vapes, Abortion Pills, and the Politics of Drug Regulation

On May 8, 2026, the Wall Street Journal reported that President Donald Trump had signed off on a plan to oust Food and Drug Administration Commissioner Marty Makary [1]. CNN confirmed the account through a senior administration official [2]. The next day, Trump told reporters outside the White House: "I've been reading about it, but I know nothing about it" [3].

That three-sentence exchange — a sourced plan to fire a top health official, followed by a presidential denial that tracks with a now-familiar pattern — encapsulates the turbulence that has defined Makary's 14-month tenure atop one of the most consequential regulatory agencies in the world.

The Flashpoints: Vapes, Abortion Pills, and Drug Rejections

Three distinct policy disputes brought Makary into direct conflict with the White House and its allies.

Flavored vapes. In early May 2026, the Wall Street Journal reported that Trump privately rebuked Makary for failing to move quickly enough on approving flavored nicotine vapes, including mango and blueberry varieties [4]. Trump sought advice from aides about the political importance of flavored vaping to younger MAGA voters, the Journal reported. Makary had attempted to block agency scientists from authorizing the products [5]. Days later, the FDA authorized several fruit-flavored vapes — a reversal that raised questions about whether political pressure had overridden the agency's scientific review process [6].

Mifepristone. Makary drew fire from anti-abortion groups and Republican lawmakers for slow-walking a safety study on mifepristone, the abortion pill [2]. The delay frustrated social conservatives who had expected the Trump FDA to take a harder line on restricting the drug's availability.

Drug approval decisions. Under Makary, the FDA denied nearly 30 percent of new drug applications — near decade highs [7]. One high-profile case involved Replimune's melanoma drug candidate, which the agency rejected despite industry expectations of approval. Makary defended the decision on CNBC, stating that "three independent teams" had arrived at the same conclusion and that the FDA had not made "corrupt sweetheart deals" [8]. In February 2026, the FDA initially refused to review Moderna's mRNA flu vaccine application before reversing course days later, with a Moderna executive calling the refusal a "complete stunner" [7].

The Numbers Behind the Turmoil

The approval rate decline is stark. From 2020 through 2024, the FDA approved roughly 85 to 88 percent of novel drug applications it considered. In the first three quarters of 2025, that rate dropped to 73 percent, while the rejection rate climbed to 15 percent — up from a historical average of about 10 percent [9].

Source: FDA / STAT News

Data as of May 8, 2026CSV

Meanwhile, per-drug approval costs have risen from approximately $30 million in 2015 to more than $50 million in 2025 [10]. A survey cited by BioSpace found that 82 percent of biopharma respondents expressed concern about the FDA's ability to function, and nearly half of investors polled called the regulatory climate the sector's "biggest issue" [11].

DOGE Cuts and the Staffing Crisis

The FDA's dysfunction predates Makary's policy disputes with the White House. In 2025, Health and Human Services Secretary Robert F. Kennedy Jr. oversaw the firing of approximately 3,500 FDA workers as part of the administration's DOGE-driven efficiency push [12]. Makary publicly defended the cuts, claiming no scientists or reviewers were let go and that the reductions targeted "administrative redundancies" [12].

But by May 2026, HHS was aiming to rehire more than 3,200 positions, including scientific reviewers and investigators — an implicit acknowledgment that the cuts had gone too far [5]. Jim Jones, the FDA's deputy commissioner for human foods, resigned in protest, citing "indiscriminate" firings [13]. Former regulators speaking to STAT described an agency struggling to rebuild institutional knowledge lost during the purge [14].

Makary's defenders, including Kennedy, argued that the cuts were overdue. "The FDA was owned by big pharma and big food, and Marty Makary has changed that now," Kennedy said [15]. Makary himself touted shorter review times and the adoption of artificial intelligence tools as evidence the streamlined agency was performing better [12].

The Case For and Against Firing Makary

The case for removal. From the White House perspective, Makary repeatedly failed to align his decisions with the president's priorities. He resisted approving flavored vapes that Trump wanted authorized. He delayed a mifepristone review that social conservatives demanded. The Taxpayers Protection Alliance, a right-leaning advocacy group, published an analysis titled "Makary Must Go," arguing that FDA costs had soared while drug rejections rose under his watch [10]. Critics on the right contend that a more compliant commissioner could accelerate approvals, reduce regulatory costs, and better align the FDA with the administration's deregulatory agenda.

The case for keeping him. Makary's supporters argue that his willingness to resist political pressure is precisely what makes him effective. His decision to ban pharmaceutical industry employees from FDA advisory panels [16] and his rejection of drugs that did not meet rigorous scientific standards represent the kind of independence the agency's credibility depends on. Rare disease advocacy groups lobbied for more regulatory flexibility, but also acknowledged the value of Makary's insistence on scientific rigor [17]. Multiple biotech CEOs, despite their frustrations, signed a letter to Makary emphasizing the need for FDA stability and warning that "volatility threatens US innovation" [11].

The Budget Pressure: User Fees and PDUFA VII

Leadership instability at the FDA arrives at a critical budgetary moment. The agency's approximately $6.7 billion annual budget is split almost evenly between industry user fees and congressional appropriations [18].

Source: FDA / Congress.gov

Data as of May 8, 2026CSV

User fees — paid by pharmaceutical companies to fund the review of their drug applications — now account for roughly 51 percent of the FDA's total program level [18]. These fees are authorized under the Prescription Drug User Fee Act (PDUFA), which must be reauthorized by Congress before it expires on September 30, 2027.

The reauthorization process is already underway. The FDA held public meetings in 2025 and has been negotiating with industry groups to develop performance goals for PDUFA VIII [19]. The HHS Secretary is required to submit the user fee agreements to Congress by January 15, 2027 [19]. A leadership vacuum — or a new commissioner unfamiliar with the ongoing negotiations — could disrupt these talks at a stage when commitments on review timelines and performance benchmarks are being locked in.

AgencyIQ, a regulatory intelligence service owned by Politico, warned that layoffs had already put "the future of FDA's user fee programs in extreme jeopardy" [20].

Who Comes Next?

The White House is reportedly considering naming Kyle Diamantas, the FDA's deputy commissioner who heads the agency's food division, as acting commissioner [21]. For the permanent role, two names have surfaced: Stephen Hahn, who served as FDA commissioner during Trump's first term, and Brett Giroir, a former acting commissioner and assistant health secretary [1].

Either choice would signal a different direction. Hahn oversaw the FDA's emergency use authorization of COVID-19 vaccines and has credibility with the pharmaceutical industry. Giroir, a retired admiral, is seen as more aligned with the administration's public health skeptics.

The FDA already operates without permanent directors at the CDC and surgeon general posts, and its two main regulatory divisions lack permanent leaders [5]. Adding the commissioner to that list would extend a period of leadership instability across the federal health apparatus.

"I Know Nothing About It": Trump's Denial and the Historical Pattern

Trump's May 9 statement — "I know nothing about it" — warrants scrutiny in light of how this administration has managed previous personnel transitions.

In March 2026, Homeland Security Secretary Kristi Noem was removed and shifted to a newly created "Special Envoy" role [22]. In April, Attorney General Pam Bondi was pushed out, with Trump framing her departure as a move to "a much needed and important new job in the private sector" [22]. National Security Adviser Mike Waltz was ousted in May 2025 after the Signal messaging scandal [22]. CDC Director Susan Monarez was fired in August 2025, weeks after her confirmation [22].

In several cases, reports of the firing preceded formal announcements by days or weeks. The administration's first-term record was even more pronounced: a Brookings Institution study found 92 percent turnover among Trump's senior "A Team" staff by January 2021 [23].

CNN reported that Trump's cabinet members themselves now worry "no one is safe" after the Bondi and Noem departures [24]. The pattern — leaked reports, presidential denials, followed by eventual removal — has repeated enough times that administration watchers treat the denial itself as a data point rather than a refutation.

What Hangs in the Balance

The FDA's drug review calendar does not pause for political drama. Upcoming decisions include an evaluation of VYVGART for seronegative myasthenia gravis (May 10, 2026) and ENHERTU for HER2-positive breast cancer (May 18, 2026) [25]. Decisions on Ozempic for peripheral artery disease and Wegovy for heart failure, originally expected in late 2025, remain pending [25].

Pharmaceutical lobbying spending surged from $391 million in 2024 to $452 million in 2025 — the largest single-year increase on record [15]. Three firms with close White House ties collected nearly $11.7 million from pharmaceutical companies in 2025 alone, up from $2.2 million the prior year [15]. These numbers reflect an industry scrambling to influence an agency whose regulatory decisions can make or break drugs worth billions.

For the patients waiting on those decisions — cancer patients, people with rare neurological disorders, those with cardiovascular disease — the question of who leads the FDA is not abstract. Leadership transitions introduce uncertainty into review timelines, and acting commissioners typically lack the political capital to make controversial approval decisions.

The Precedent Question

No FDA commissioner has been fired outright in the agency's 120-year history. Commissioners have resigned under pressure — most notably Lester Crawford, who stepped down in 2005 after just two months amid ethics investigations, and Andrew von Eschenbach, who faced calls for removal but served out his term. The position is not technically protected by the kind of for-cause removal statutes that shield some independent agency heads, but the norm of non-interference has held for over a century.

If Trump follows through, Makary's removal would set a new precedent: a president firing an FDA commissioner because the commissioner refused to approve specific products the president favored. Whether that precedent strengthens or weakens the agency depends entirely on whom you ask — and what you believe the FDA is for.