CDER, CBER Directors Removed as FDA Leadership Changes Continue

Two more executive leaders at the FDA are being replaced after the removal of Beth Høeg, MD, PhD, director of the Center for Drug Evaluation and Research (CDER)—who reports that she was fired—and Katherine Szarama, PhD, director of the Center for Biologics Evaluation and Research (CBER), according to CNBC.¹

“Changes at the top of the FDA matter far beyond Washington. The agency quietly influences daily life in ways most people never notice,” wrote Brian Castrucci for Forbes.² “It oversees prescription and over-the-counter (OTC) medicines, vaccines, medical devices, infant formula, tobacco products, and much of the nation’s food supply, as well as veterinary medicine and the safety of cosmetics.”

The dismissal of Høeg, an epidemiologist who had been elevated to the CDER role in December, adds a layer of controversy to the agency’s recent turmoil. She explicitly stated on social media that she was fired after refusing to sign a letter of resignation, noting that officials told her the directive came from “someone way above their pay grade.”^3-5

Szarama, on the other hand, is stepping aside from the acting director position at CBER after only 10 days but is expected to remain with the agency in a different capacity.^1,3

READ MORE: Makary Resigns as FDA Commissioner After 13 Months Via Screenshot

To fill these critical vacancies, the agency has named Michael Davis, previously a deputy director, as the acting head of CDER, and Karim Mikhail, a former pharmaceutical executive, takes over at CBER. These shifts are accompanied by the removal of Chief of Staff Jim Traficant, who is being replaced by acting appointee Lowell Zeta.^1,3,5

“Frequent leadership transitions at the FDA can introduce uncertainty at a time when consistency is critical for maintaining confidence among clinicians, patients, and industry,” Laura Knockel, PharmD, BCACP, director at Pharmacy Practice Laboratories; clinical associate professor at the University of Iowa College of Pharmacy; and ambulatory care clinical pharmacist at University of Iowa Health Care, told Drug Topics®. “Stable and transparent leadership processes ensure timely and efficient review of medications, vaccines, and other innovations.”

What These Changes Mean for Pharmacy

For pharmacists, this leadership churn is not merely an administrative shuffle but a potential disruption to regulatory signaling and policy stability. Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPS (AQ-Cardiology), CACP, a cardiovascular clinical pharmacist, noted that reduced policy and guidance output could lead to product delays and significant confusion regarding federal requirements.^5,6

The pharmacy profession faces a period of acute uncertainty concerning high-stakes medications and operational standards. Specifically, the pace of OTC rulemaking is expected to slow, and the future of behind-the-counter access models—which would place pharmacists at the center of expanded medication access—remains in limbo.⁶

The catalyst for this overhaul was the sudden resignation of Marty Makary, MD, MPH, following months of friction over the agency’s agenda. A major flashpoint involved presidential pressure to approve fruit-flavored e-cigarettes, a move Makary reportedly resisted before his departure.

Though Makary’s resignation report highlighted successes in reducing drug review times and advancing rare disease pathways, his exit has left many unresolved questions for stakeholders. Kyle Diamantas, JD, a lawyer with a background in food safety, is currently serving as acting commissioner, and he may hold the role for an extended period given the political climate surrounding upcoming elections.^3,6

FDA Turnover Amid Continuous Uncertainty in Federal Agencies

Amid this reported turmoil, perhaps the most pressing issue for pharmacists is the status of mifepristone. Following a 5th Circuit Court of Appeals ruling that restricted telehealth and pharmacy dispensing, a temporary Supreme Court stay has kept access intact for now. However, a formal FDA safety review scheduled for this fall could reshape the current access framework, requiring pharmacists to monitor dispensing requirements in real-time.⁶

This instability extends to the biologics sector, where repeated leadership changes at CBER, including the departure of Vinay Prasad, complicate long-term planning for vaccine manufacturers and clinical investigators.^1,5

This pattern of acting leader churn is highly unusual by historical standards, with CDER alone seeing 5 different heads in the span of a single year. Furthermore, the vacancies are mirrored in other federal health sectors, as the administration seeks to fill top roles at the CDC and the office of the Surgeon General.^1,3,5

As Forbes emphasized, the FDA’s authority ultimately rests on its credibility and the public’s belief that decisions are made based on evidence rather than political pressure.^1,2

For the practicing pharmacist, the coming months will require heightened engagement as the agency navigates these volatile transitions and determines the future of drug safety and access.⁶

“Continued attention to these areas will be important to support trust in the regulatory system and its decision-making,” Knockel concluded.

READ MORE: FDA Updates

REFERENCES

1. Peebles A. FDA shuffles top drug, biologics leaders in latest shakeup. CNBC. May 16, 2026. Accessed May 19, 2026. https://www.cnbc.com/2026/05/15/fda-shuffles-top-drug-biologics-leaders-in-latest-leadership-shakeup.html

2. Castrucci B. Why FDA leadership changes matter for every American. Forbes. May 18, 2026. Accessed May 19, 2026. https://www.forbes.com/sites/briancastrucci/2026/05/18/how-a-leadership-change-at-the-fda-could-impact-daily-lives/

3. Jacobus N. FDA makes leadership overhaul following commissioner Makary’s departure: report. PharmExec. May 18, 2026. Accessed May 19, 2026. https://www.pharmexec.com/view/fda-leadership-overhaul-commissioner-makary-departure-report

4. McGreevy R. Second FDA executive departing organization in less than a week as top drug regulator claims she was fired. Fox News. May 16, 2026. Accessed May 19, 2026. https://www.foxnews.com/politics/second-fda-executive-departing-organization-less-week-top-drug-regulator-claims-fired

5. Zubulake Z. Everything to know about FDA’s personnel shifts. PharmTech. May 18, 2026. Accessed May 19, 2026. https://www.pharmtech.com/view/everything-to-know-about-fdas-personnel-shifts

6. Halpern L. After Makary: what the FDA’s leadership shake-up means for pharmacy. Pharmacy Times. May 13, 2026. Accessed May 19, 2026. https://www.pharmacytimes.com/view/after-makary-what-fda-leadership-shake-up-means-for-pharmacy