On May 12, 2026, FDA Commissioner Dr. Marty Makary resigned. Within days, the acting heads of both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research were also out the door, along with the agency’s chief of staff. The FDA now enters its most consequential leadership vacuum in decades, without a permanent commissioner, without permanent leadership at either of its two most critical drug-review centers, and with a career workforce that spent the past 13 months watching senior expertise walk out the building.
Every pharmacist who interacts with the FDA pipeline, biosimilar pathways, compounding regulations, vaccine policy, or OTC reclassification processes needs to understand what just happened and what it means for the months ahead.
How It Ended
Makary’s 13-month tenure ended after escalating clashes with the Trump administration over flavored vape approvals, mifepristone policy, and broader agency management. His resignation was confirmed May 12, 2026, with President Trump speaking to reporters on the White House lawn and Kyle Diamantas, the FDA’s deputy commissioner for food, named as acting commissioner.
The proximate cause was the FDA’s authorization of fruit-flavored e-cigarettes. Makary opposed the approval. The White House pressed him to support it. Rather than testify before Congress the following day defending a decision he did not support, he stepped down.
Diana Zuckerman, president of the National Center for Health Research, captured the broader dynamic plainly: “He has offended almost everyone involved in FDA issues, which is not easy to do.”
The resignation capped 13 months that analysts at Capital Alpha described as “the most damaging period in FDA history.”
The Depth of the Institutional Damage
The headline is the resignation. The story is what was already depleted before it.
Since Makary was confirmed in March 2025, the FDA shed approximately 3,500 employees, driven out by cuts imposed through HHS. The damage extended to the highest levels of leadership. The Center for Drug Evaluation and Research cycled through four directors in a single year. Richard Pazdur, a respected career regulator, retired in December after citing political interference as his reason for leaving.
The Center for Drug Evaluation and Research had five different directors in 2025 alone. Leaders at lower levels were pushed out or voluntarily departed at a steady clip throughout the year.
With the ink barely dry on Makary’s resignation, the acting heads of both CDER and CBER also departed. Tracy Beth Høeg, acting CDER director, was fired. Katherine Szarama, acting CBER director for only three weeks, also left. The chief of staff was removed. Lowell Zeta was named acting chief of staff. One expert in FDA regulatory law stated: “I don’t know that we’re going to see the desired predictability for quite some time.”
CBER has now had six leaders since January 2025. Karim Mikhail, a former Merck and Amarin executive, was named acting CBER director. Michael Davis, CDER’s deputy director for roughly a year, took over CDER in an acting capacity. A senior administration official indicated a permanent commissioner nominee could be named within weeks, though Senate confirmation would add further uncertainty to the timeline.
Career FDA officials told multiple outlets there was widespread relief among rank-and-file staff inside the agency when Makary’s resignation was confirmed. The acting CDER director’s replacement was described by one official as “an outstanding person and great leader, with high integrity and sound judgment.” But the relief inside the building does not erase the institutional knowledge that left with the 3,500 staff who are no longer there.
What This Means for the Pharmacy Pipeline
The FDA regulates approximately one-fifth of all consumer spending in the United States. The consequences of leadership instability are not abstract. They are concrete, clinical, and arriving at pharmacy counters with timeline uncertainty attached.
Volatility at CBER, including repeated leadership changes, complicates biologics and vaccine sponsors’ long-horizon regulatory planning and investment assumptions. Leadership changes are not occurring in isolation. They follow sustained personnel losses across career scientific staff, which directly affects the agency’s review capacity. Persistent vacancies at the CDC and surgeon general positions mirror the instability and create broader public health governance gaps that may affect interagency alignment and policy coherence.
For pharmacists, the disruption touches five specific areas:
Drug approvals and NDA timelines. When career reviewers depart and institutional knowledge leaves with them, review timelines for new drug applications and supplemental NDAs become less predictable. This affects when new therapies, including the GLP-1 approvals and retatrutide program covered in prior issues of this newsletter, move from pipeline to shelf.
Biosimilar pathways. CDER oversees small molecule and chemically synthesized drugs. CBER oversees biological products, vaccines, and many biosimilars. Both centers now have acting leadership with no permanent director. The streamlined interchangeability guidance released in late 2025 came from a functioning CDER. Regulatory continuity on biosimilar substitution policy requires stability in that same center.
Compounding regulations. FDA oversight of 503A and 503B compounding pharmacies flows through CDER. During leadership transitions, the agency’s enforcement posture and guidance interpretation can shift without formal rulemaking, creating compliance uncertainty for pharmacies operating compounding programs.
Vaccine policy and scheduling. CBER manages the biologics license applications for all vaccines. The center has had six leaders since January 2025. Combined with the vaccine study suppression story covered in a prior issue, CBER’s instability creates direct uncertainty for pharmacists administering vaccines and counseling patients about coverage and scheduling decisions.
OTC reclassification decisions. The behind-the-counter and nonprescription pathways that expand pharmacist prescribing authority flow through FDA rulemaking. Leadership instability slows rulemaking. The scope expansion pharmacists are advocating for depends on an FDA that can execute regulatory decisions consistently.
What the Pharmacist Action Plan Looks Like
The administration has indicated a permanent commissioner nominee could emerge within weeks, but Senate confirmation adds further uncertainty to any timeline. The FDA is currently operating with acting leadership at its commissioner’s office, both major drug review centers, and its chief of staff position simultaneously.
In a stable regulatory environment, pharmacists can rely on regular FDA guidance updates to arrive on predictable schedules. In the environment that exists right now, important regulatory updates, guidance withdrawals, enforcement discretion decisions, and policy reversals are more likely to arrive without announcement or advance notice.
The three actions that matter most in this environment:
Set up FDA Federal Register and MedWatch alerts. Go to fda.gov and subscribe to email alerts for your practice areas: drug safety communications, new drug approvals, biosimilar approvals, compounding guidance updates, and vaccine-related communications. These updates have historically arrived as quiet regulatory notices before they became mainstream news. In an unstable leadership environment, the gap between quiet notice and mainstream news can be significant. The pharmacist who reads the Federal Register notice at publication is the one who can act before competitors do.
Subscribe to ASHP regulatory news updates. ASHP maintains active surveillance of FDA activity as it affects hospital and health-system pharmacy practice. Their regulatory alerts arrive faster than most state pharmacy association communications and provide practice-specific context that a raw Federal Register notice does not.
Contact your state pharmacy association today if you have compounding operations. Compounding regulations are specifically vulnerable during FDA leadership transitions because enforcement posture is discretionary, not solely rulemaking-based. Your state board of pharmacy and your state association are monitoring this situation and need to know which pharmacies in their membership have active compounding programs and what their current compliance posture looks like.
The Longer View
The FDA’s authority over drug safety, efficacy, and access is not permanently diminished by a leadership change. The career staff who remain, the statutory authority the agency holds, and the scientific infrastructure that has been built over decades are not gone. They have been damaged, depleted, and destabilized. The difference matters.
Under Makary, the FDA became an unexpected source of drama and a lightning rod for HHS Secretary Robert F. Kennedy Jr.’s broader efforts to overhaul health policy. His departure means the administration must now fill three Senate-confirmed health positions simultaneously: FDA commissioner, CDC director, and surgeon general.
The pharmacists who track these developments closely, maintain active regulatory surveillance, and keep their compliance and clinical protocols current during the transition will be the ones who adapt fastest when the next guidance drops. The ones who wait for a new commissioner to settle in before paying attention may find themselves reacting to decisions that were made six months earlier.
In an uncertain regulatory environment, proximity to information is a clinical and business advantage. Build that proximity now.
Sources: Pharmacy Times (Breaking: Amid Mounting Pressure, FDA Commissioner Marty Makary to Resign, May 12, 2026), CNBC (Marty Makary Resigns as FDA Commissioner Following Industry and White House Backlash, May 12, 2026), NPR (FDA Commissioner Makary Resigns After Tumultuous Tenure, May 12, 2026), CBS News (Marty Makary Resigns as FDA Commissioner After Internal Tensions, May 12, 2026), Axios (Marty Makary Out as FDA Chief, May 12, 2026), Time (FDA Commissioner Marty Makary Resigns, May 12, 2026), PhillyVoice (FDA Commissioner Resigns After Dispute Over Fruit-Flavored Vapes), Newsweek (FDA Commissioner Marty Makary Resigns: Who Is Acting Chief Kyle Diamantas?), BioSpace (After Most Damaging Period in FDA History, Makary Will Be Hard to Replace, May 12, 2026), Fierce Pharma (After Makary Departure, CDER Chief Høeg and CBER’s Szarama Exit Top FDA Posts, May 2026), PharmExec (FDA Makes Leadership Overhaul Following Commissioner Makary’s Departure, May 2026), Pharmaceutical Technology (Everything to Know About FDA’s Personnel Shifts, May 2026), The FDA Group Insider (A Quick Explainer on FDA’s Leadership Shakeups, May 2026), STAT News (Vinay Prasad Leaves FDA, March 2026)
