Second FDA Senior Official Departs in Less Than a Week as Top Drug Regulator Claims She Was Fired

On Friday, May 16, 2026, Dr. Tracy Beth Høeg announced on social media that she had been fired from her position as acting director of the FDA's Center for Drug Evaluation and Research (CDER)—the division responsible for regulating every prescription and over-the-counter drug in the United States [1]. Her departure came just four days after FDA Commissioner Marty Makary resigned under pressure from the White House [2]. Together, these exits represent the latest chapter in an extraordinary period of instability at the Food and Drug Administration, where five senior leaders have departed since the start of 2025.

The Timeline of Departures

The hemorrhaging of FDA leadership began in March 2025, when Dr. Peter Marks—a nearly 10-year veteran who led the Center for Biologics Evaluation and Research (CBER)—was forced out after receiving an ultimatum from HHS Secretary Robert F. Kennedy Jr.: resign or be fired [3]. In his resignation letter, Marks wrote that "truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies" [4].

In December 2025, Dr. Richard Pazdur, a 26-year FDA veteran who had profoundly shaped the agency's approach to cancer drug development, filed retirement papers just three weeks after being elevated to CDER director. Multiple sources said Pazdur had growing concerns about the direction of the agency, including disagreements over Makary and Prasad becoming involved in individual drug decisions [5].

Dr. Vinay Prasad, who replaced Marks as CBER director, announced in March 2026 that he would step down at the end of April. His tenure was marked by a series of controversial decisions, including declining to review Moderna's mRNA flu vaccine application and issuing an unsubstantiated memo claiming COVID vaccines had killed at least 10 children [6].

Then came the rapid-fire departures of May 2026: Commissioner Makary on May 12, followed by Høeg on May 16.

Source: Compiled from news reports

Data as of May 17, 2026CSV

Who Fired Whom—and Under What Authority

The legal basis for these removals varies. Makary, a Senate-confirmed political appointee, served at the pleasure of the president—Trump reportedly signed off on his ouster after clashes over tobacco regulation and abortion drug access [7]. Høeg's case is murkier. She told reporters: "I said I didn't want to resign. They made it clear that it wasn't their decision. They said it was from someone above them, from someone way above their pay grade" [1].

The Trump administration has pursued a broader strategy to weaken civil service protections through its "Schedule Policy/Career" classification—a renamed version of the original Schedule F executive order signed January 20, 2025. This reclassification exempts tens of thousands of federal employees in "policy-influencing" positions from long-standing civil service protections that prevent firing for political reasons [8]. In February 2026, the administration moved to finalize the rule [9].

Legal challenges are underway. Public service organizations including AFSCME filed an updated legal challenge arguing the policy violates merit-based principles embedded in federal employment law [10]. The Senate's FY 2026 FDA funding bill includes a provision instructing FDA to lift hiring restrictions for scientists, product reviewers, and inspectors within 30 days—though the House version omits this language [11].

The Leadership Vacuum: Who Is Running the FDA Now

Kyle Diamantas, a 37-year-old corporate lawyer and friend of President Trump's eldest son, is now serving as acting FDA commissioner. Diamantas has no medical degree. Prior to joining the FDA as Deputy Commissioner for Food, he was a partner at Jones Day in Miami, where he advised FDA-regulated industry clients on regulatory and compliance matters [12].

At CDER, Høeg's former deputy Dr. Mike Davis has stepped into the acting director role [13]. The CBER directorship has been vacant since Prasad's April departure. All deputy center director positions are reported to be open due to layoffs and voluntary resignations [14].

Source: FDA records and news reports

Data as of May 17, 2026CSV

The Pharmaceutical Pipeline at Stake

The FDA's drug and biologics centers oversee a pipeline worth hundreds of billions of dollars. BioPharma Dive identified multiple major approval decisions pending in Q2 2026 alone [15]. The broader regulatory environment has been marked by what industry observers call "unpredictability"—biotechnology executives had hoped 2025's turbulence would subside, but layoffs, leadership changes, and surprise shifts in decision-making continued into 2026 [16].

Specific concerns include:

• The CBER vacancy leaves no permanent leader overseeing vaccine and gene therapy approvals
• The FDA's 19% workforce reduction, primarily targeting what the administration called "administrative" functions, eliminated approximately 10,000 positions at HHS including deep cuts at FDA [14]
• The agency was simultaneously involved in "multiple, unusual spats with drugmakers over controversial rejections and review delays" [16]

Diana Zuckerman, president of the National Center for Health Research, said of Pazdur's departure: "Many of us appreciate that he was willing to express his concerns about FDA's recent plans to speed up the approval process at a time when FDA had lost staff and expertise" [5].

The Case for a Shakeup

Defenders of the administration's approach argue that FDA leadership had become slow, unaccountable, and too cozy with the industries it regulates. Kennedy's "Make America Healthy Again" agenda has specifically targeted what it characterizes as conflicts of interest within the agency [17].

The FDA under previous administrations faced legitimate criticism: drug approval timelines that frustrated patients with terminal illnesses, advisory committees with industry ties, and a revolving door between the agency and pharmaceutical companies. Makary himself initially pledged to accelerate FDA decisions and implemented reforms including lowering pivotal trial requirements and establishing a new approval framework for rare diseases [16].

Some industry stakeholders view the current acting commissioner favorably. STAT News described Diamantas as a "no drama" figure who "should serve biotech well" [18]. His background in food safety regulation and regulatory compliance gives him familiarity with the agency's operations, even if he lacks medical training.

However, the administration's own record complicates the anti-capture argument. Kennedy's FDA launched a "listening tour" open only to pharmaceutical and biotech CEOs who already have products under review—excluding patients, doctors, and the general public [19]. A study found that industry-related conflicts of interest on the CDC's vaccine advisory committee had already been "virtually eliminated" before Kennedy purged its members [20].

International Comparisons

The scale of FDA leadership turnover stands in contrast to peer regulatory agencies. The European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada all maintain structural independence from direct political control over individual personnel decisions [21].

The EMA operates as an independent body within the EU framework, with its executive director appointed through a process designed to insulate the role from member-state political pressure. The MHRA functions as an executive agency with its own governance structure. Neither has experienced anything comparable to five senior leadership departures in 14 months driven by political pressure.

Canada offers a partial exception: resignations from its Patented Medicine Prices Review Board in 2023 raised questions about federal interference in an arms-length regulator. But these involved a pricing body, not the core drug safety apparatus [22].

Conflicts of Interest and Ethics Questions

Kennedy himself faces documented conflicts. He maintains an agreement with the law firm WisnerBaum under which he receives 10% of funds awarded in successful cases he refers—earning approximately $2.5 million over three years, including from anti-vaccine litigation [23]. Senator Elizabeth Warren pressed Kennedy on these arrangements during his confirmation process, and he eventually agreed to amend his ethics agreement [24].

The question of whether independent ethics review has been conducted on the decision-making chain that led to these firings remains unanswered. Kennedy's HHS oversees the FDA, and his documented financial interests in vaccine litigation create at minimum an appearance of conflict when his office pressures vaccine regulators to resign.

Congressional Response and Legislative Proposals

Congress has responded with competing proposals. The bipartisan "Saving the Civil Service Act" (H.R. 492 / S. 134), introduced in January 2025 by Representatives Connolly, Fitzpatrick, Mfume, and Bacon, would permanently prohibit the Schedule Policy/Career classification [11]. The measure has not advanced to a vote.

The Senate Appropriations Committee's FY 2026 FDA funding bill includes language directing the agency to lift hiring restrictions on scientists and reviewers [11]. The "Better FDA Act of 2025" (S. 3122) and "FDA Modernization Act 3.0" (H.R. 2821) address various aspects of FDA reform but do not specifically insulate career scientific staff from political removal [25].

A May 2026 article in Science warned of "institutionalizing politicized science," arguing that the current trajectory could permanently alter the relationship between career regulatory scientists and political leadership [26].

What Comes Next

Names reported under consideration for a permanent FDA commissioner include former Commissioner Stephen Hahn, who led the agency from 2019 to 2021, and former Acting Commissioner Brett Giroir [12]. Neither appointment would resolve the deeper structural question: whether a president can effectively hollow out scientific leadership at a regulatory agency through a combination of Schedule F reclassification, political pressure, and forced resignations.

The precedent being set extends beyond the FDA. If career regulatory scientists can be removed for disagreeing with political appointees on scientific questions—as Peter Marks was—the independence of every federal scientific agency is implicated. The FDA's credibility rests on the premise that drug approval decisions reflect scientific evidence rather than political preference. Whether that premise survives the current period will depend largely on whether Congress acts to codify protections that were previously maintained by norm rather than statute.

For now, the agency responsible for the safety of America's food, drugs, vaccines, and medical devices is led by an acting commissioner with no medical background, an acting drug center director days into the role, and no permanent biologics director—the most depleted senior leadership in the FDA's 118-year history.