The FDA Just Lost Its Third Commissioner in Three Years
The White House just approved plans to oust FDA Commissioner Marty Makary after only 14 months on the job, marking the third leadership change at the agency in three years. For biotech investors and companies waiting on drug approvals, the turbulence is just getting started.
Fourteen Months and Out
Most people don't last 14 months at a startup before updating their LinkedIn. Marty Makary just got that same timeline at the FDA.
The White House approved a plan on May 8, 2026, to remove Makary as FDA Commissioner, making him one of the shortest-tenured agency chiefs in modern history. He'd been confirmed by the Senate just 13 months earlier, in March 2025, on a 56-44 vote. Now the administration is shopping for his replacement while the biotech industry watches with a mix of exhaustion and dread.
This isn't just a personnel shakeup. It's the third FDA leadership change in three years: Robert Califf stepped down in early 2025, Makary took over, and now he's being shown the door. For an agency that reviews life-or-death medical products, that kind of turnover is like changing pilots mid-flight. Repeatedly.
The Guy Who Tried to Remake the FDA in a Year
Makary wasn't a wallflower. The Johns Hopkins surgeon came in with a mandate from the Trump administration: cut bureaucracy, speed up approvals, align with HHS Secretary Robert F. Kennedy Jr.'s "Make America Healthy Again" agenda. And he moved fast.
His signature proposal? Making a single pivotal trial the default for drug approvals, down from the traditional two. One analyst called it "the biggest jailbreak in biotech history." He launched pathways for ultrarare diseases, eased biosimilar requirements, ended certain animal testing mandates, and started publishing FDA rejection letters publicly for the first time.
On food safety, he went after petroleum-based dyes, phthalates, and BHA/BHT. He requested a $6.8 billion budget for fiscal year 2026 during his final Senate testimony on May 22 (the ouster news broke just days earlier).
By the numbers, Makary pushed through roughly 30 policy shifts in 13 months. That's an aggressive pace by any standard.
So Why Is He Getting Fired?
The short answer: he frustrated everyone who mattered, often simultaneously.
Makary's FDA issued a refuse-to-file letter for Moderna's mRNA flu vaccine application. That decision came from CBER (the biologics review center) and escalated into a broader controversy aligned with RFK Jr.'s vaccine skepticism.
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Anti-abortion Republicans grew irritated over what they saw as slow-walking on mifepristone restrictions. Vaping companies and their allies pushed back when Makary resisted authorizing flavored vapes. And rare disease drugmakers complained about inconsistent reviews, pointing to surprising rejections of therapies from Replimune and Capricor.
Meanwhile, the internal situation was chaos. Richard Pazdur, the Director of CDER (the Center for Drug Evaluation and Research), resigned in December 2025, accusing Makary of breaching the traditional "wall" between leadership and scientific reviewers. CBER cycled through five leaders in 18 months. Staff morale cratered after 3,500 FDA employees were cut in HHS layoffs.
When you're alienating Congress, industry, and your own staff, the clock is ticking.
The Revolving Door Problem
Historically, FDA Commissioner turnovers create measurable damage. The pattern is remarkably consistent: every leadership vacuum costs the industry 2-4 months of delays on pending applications.
Now apply that to 2026. Several major drugs are in the approval pipeline. The biologics center has no permanent leader. And the agency is about to lose its top official with no confirmed successor in place.
Brian Abrahams of RBC Capital Markets put it bluntly: "Volatility in leadership and uncertainty around development adds risk to the drug development process and these investments." MassBio CEO Kendalle Burlin O'Connell said the instability has made "long-term planning and investment decisions increasingly difficult."
Who's Next?
The administration is reportedly considering former FDA leaders for an interim role. Three names have surfaced: Stephen Hahn (Trump's previous FDA Commissioner), Brett Giroir (former Acting Commissioner), and Sara Brenner (former Principal Deputy Commissioner).
No permanent successor has been named. And if history is any guide, the interim period will last 4-8 months before a confirmed replacement takes the chair.
That's 4-8 months of an agency running on autopilot during one of the most complex regulatory periods in its history. The single-trial approval pathway is still being finalized. Biosimilar guidance remains in draft form. The adverse event reporting system overhaul (AEMS) was supposed to go fully real-time by the end of May 2026. All of these now face uncertain futures.
The Bigger Picture: Can the FDA Function Like This?
There's a deeper question beneath the personnel drama. The FDA was designed to operate with some insulation from political winds. Commissioners serve at the President's pleasure, yes, but the expectation has always been that scientific review processes remain independent of whoever occupies the corner office.
Makary's tenure tested that boundary in both directions. He pushed top-down policy changes (like the acetaminophen-autism labeling, the HRT boxed warning removal) that critics said bypassed normal scientific channels. But he also got fired, in part, for not bending enough to political pressure on specific products.
The lesson for biotech companies is uncomfortable: the FDA has become a political football, and no amount of good data guarantees a predictable path to market. You can design a perfect trial, hit every endpoint, and still find yourself caught between a commissioner's ideology and a president's frustration.
What This Means for Your Portfolio
If you're invested in biotech (or thinking about it), here's the practical calculus:
Near-term pain is likely. Leadership transitions historically add 10-20% to approval timelines. Companies with PDUFA dates in the next six months face elevated uncertainty, particularly in biologics and rare diseases where the review apparatus is already understaffed.
Makary's reforms aren't dead, but they're on life support. The single pivotal trial framework, the plausible mechanism pathway for ultrarare diseases, the biosimilar simplification: all were announced but not all were finalized through formal rulemaking. An interim commissioner may lack the mandate (or interest) to push them across the finish line.
Watch the interim appointment closely. If it's someone like Stephen Hahn, who ran the agency during COVID-19's early days and has credibility with career staff, the transition could be smoother. If it's someone more politically aligned with RFK Jr.'s views, expect continued volatility.
The biotech sector has survived FDA leadership drama before. It always does. But "surviving" and "thriving" are different things, and right now, the industry is stuck wondering which version of the FDA it'll be dealing with next quarter. That uncertainty alone is expensive.
The Bottom Line
Marty Makary tried to do ten years of FDA reform in one year. He made real changes: transparency improvements, faster pathways, modernized processes. He also made real enemies: inside the building, on Capitol Hill, and at 1600 Pennsylvania Avenue.
Now the biotech industry gets to experience its third FDA leadership transition since 2024, with all the delays, confusion, and risk repricing that entails. For companies waiting on approvals, for patients waiting on treatments, and for investors waiting on catalysts, the message is clear: buckle up for another bumpy stretch at the intersection of science and politics.
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