FDA Fires Drug Center Head Høeg Days After Commissioner Makary's Exit

The Food and Drug Administration’s acting drug center director, Tracy Beth Høeg, was fired Friday after refusing to resign — the second top-level departure from the agency in five days and the latest sign of the leadership turbulence engulfing the nation’s primary drug regulator.

Two FDA officials visited Høeg at her office Friday and told her she could either resign voluntarily or be terminated. She declined. “Today marked 6 months as head of CDER at @FDA & today I was fired,” Høeg wrote in a post on X Friday night. “I’m incredibly grateful to have had this opportunity to serve this country & proud of the work we did. FDA staff are smart, talented, supportive & don’t get enough credit. I learned so much & leave with no regrets.” She later confirmed she had been given the choice to resign and refused.

Michael Davis, the center’s deputy director, will serve as acting director of the Center for Drug Evaluation and Research, the FDA confirmed. Davis is a career agency scientist, in contrast to Høeg, whose background in epidemiology and sports medicine, and her public skepticism of certain COVID-19 vaccines during the pandemic, had drawn sustained criticism from senior career FDA staff since her December 2025 appointment.

From Makary to Høeg in Five Days

The proximate cause of both departures was intensifying White House pressure over drug and product regulatory decisions the Trump administration found either too slow or politically inconvenient.

Commissioner Marty Makary resigned May 12 after opposing a White House-backed decision to approve a line of fruit-flavored e-cigarettes from Glas Inc. — a significant reversal of the FDA’s longstanding resistance to such products, which public health advocates argue are engineered to attract minors. Makary resisted the approval; when it went through over his objections, the sequence of events that ended his tenure began. Kyle Diamantas, the FDA’s deputy commissioner for food, was named acting commissioner the same day.

Acting Commissioner Diamantas had been a relatively low-profile figure inside the FDA before his elevation. A lawyer by training with a regulatory focus on food safety rather than drug policy, he signaled in his first public statements that his priorities would include moving faster on the ongoing legal and regulatory fight over mifepristone, the most commonly used medication for abortion, which anti-abortion groups have pressured the agency to restrict or remove from the market. The timeline for any mifepristone action remains unclear.

Høeg’s firing, arriving four days after Makary’s exit, appears to represent a housecleaning under the new acting commissioner rather than a dispute over a specific regulatory decision. The FDA did not issue a public statement explaining the reason for her termination.

Høeg’s Six Months at CDER

Høeg was the fifth person to lead the Center for Drug Evaluation and Research under the Trump administration’s second term — a rate of turnover that has alarmed pharmaceutical executives and veteran regulators who depend on CDER’s leadership for predictable, consistent drug approval timelines.

She was appointed in December 2025, following the abrupt departure of Dr. Richard Pazdur — a widely respected veteran oncologist who spent more than 27 years at the FDA before serving a brief stint as acting CDER director and then leaving the agency. Pazdur’s departure had itself drawn alarm in the biopharma industry, and he has since become a vocal public critic of the FDA’s handling of its career-staff reduction-in-force operations in 2025. The Biotechnology Innovation Organization and several major pharmaceutical trade groups have since publicly called for Pazdur to return to the agency in a leadership capacity.

Høeg’s background did not fit the typical profile of a CDER director. She had spent her academic career in epidemiology and sports medicine, publishing research primarily on sports injuries and COVID-19 outcomes. During the pandemic, she became a notable public voice questioning the safety profile of mRNA vaccines, in particular their administration to children. She helped draft a memo that linked several children’s deaths to the COVID-19 vaccine without providing data to support the claim — a document that drew rebuke from established public health bodies.

At the start of 2026, Høeg led the Trump administration’s overhaul of the recommended childhood vaccination schedule, reducing the number of recommended vaccines from 17 to 11. The revision drew sharp condemnation from the American Academy of Pediatrics and other pediatric medical societies, who said the change was not grounded in clinical evidence and would leave children vulnerable to preventable diseases.

At CDER, Høeg oversaw continued approvals of new drugs and biologics — including several oncology therapies — but did so against a backdrop of senior staff attrition that had begun with the agency’s reduction-in-force operations in late 2025. The departure of experienced reviewers and medical officers created a growing backlog of drug applications that pharmaceutical trade groups lobbied both Makary and Diamantas to address. Høeg’s own departure, combined with Makary’s, leaves the agency’s two most senior positions filled on an acting basis simultaneously for the first time in the current administration.

What CDER Does and Why the Void Matters

The Center for Drug Evaluation and Research is the FDA division responsible for reviewing and approving new prescription and over-the-counter drugs before they reach patients. The center employs approximately 5,000 scientists, physicians, and regulatory specialists, and its decisions determine whether a new treatment — for cancer, heart disease, diabetes, psychiatric illness, or any other condition — clears the bar required to reach U.S. pharmacies and hospitals.

Drug companies file New Drug Applications and Biologics License Applications with CDER, which assigns review teams to assess safety and efficacy data from clinical trials. The center can approve, reject, or request additional information. Its timelines are governed by statute under the Prescription Drug User Fee Act — known as PDUFA — which requires the FDA to act on most new drug applications within ten to twelve months of submission, in exchange for user fees that fund a substantial share of CDER’s operating budget.

Senior leadership transitions at CDER create immediate practical uncertainty even when review teams continue their work uninterrupted. Decisions involving novel drug classes, appeals of prior rejections, and policy-level questions about drug classification or new indications typically require sign-off from senior leaders. When those positions are filled on an acting basis by officials new to the role, the timeline for consequential decisions can slip — and in some cases has. The pharmaceutical industry has been tracking closely whether CDER’s review calendar will remain on schedule through the summer.

The agency’s credibility with both industry and the public also depends in part on the perception of institutional stability and scientific independence. Each leadership departure tests that credibility, particularly when it arrives under circumstances that suggest political interference with regulatory processes — which is how Makary’s exit has been widely characterized by former FDA officials and congressional Democrats.

What Changes Now

Michael Davis brings career-regulator continuity that Høeg did not. As CDER’s deputy director, he has overseen many of the center’s operational functions and is familiar with the review pipelines, the staffing challenges, and the institutional machinery that continued functioning through the recent leadership churn. He is expected to maintain the existing review calendar without major disruption.

Whether Davis will serve beyond a transitional period depends on whether the White House nominates a permanent CDER director — a Senate-confirmed position. No nomination has been announced. The biopharma industry’s sustained push for Pazdur’s return, expressed through trade group statements, has not produced a visible response from the administration.

The larger challenge at the FDA remains structural. The agency lost significant numbers of experienced reviewers and senior scientists in the 2025 reduction-in-force operations, and the institutional knowledge that career staff accumulates over years of reviewing novel therapies is not easily replaced. Cycling through acting CDER directors at the pace the current administration has established makes it harder to sustain the consistent regulatory direction that drug development timelines and patient access to new treatments both depend on. Davis’s appointment as the sixth person to hold the CDER leadership position in the Trump administration’s second term does not resolve that structural deficit — but it at least ends, for now, the week’s accelerating pace of departures.