The FDA's Brain Drain Is Biotech's Talent Gold Rush
The FDA has lost roughly 3,500 employees in six months, and biotech companies are racing to scoop up the regulatory talent walking out the door. Former FDA leader Stephen Hahn's jump to Turn Therapeutics is just the latest sign of a brain drain reshaping both the agency and the industry.
The Regulator Becomes the Regulated
Imagine your favorite restaurant's head chef quits and walks across the street to open a rival spot. That's basically what's happening at the FDA right now, except the "chef" knows every health code violation you could possibly commit, and the "rival restaurant" is willing to pay handsomely for that knowledge.
The latest example: Stephen Hahn, M.D., a former senior FDA leader, just joined Turn Therapeutics as executive clinical and regulatory lead. His job? Steering the regulatory strategy for GX-03, the company's topical eczema treatment currently in a phase 2 trial. It's a move that would barely register in normal times. But these are not normal times.
The FDA is hemorrhaging talent at a pace that would make even the most cynical Beltway observers do a double take. And biotech companies are lining up to catch every person who walks out the door.
A Revolving Door Spinning at Record Speed
The so-called "revolving door" between the FDA and industry has always existed. Regulators leave government, take their expertise to private companies, and everyone pretends to be surprised. But 2025 and 2026 have turned that revolving door into something closer to a centrifuge.
Consider the scale. Roughly 3,500 employees have left the FDA over the past six months alone. That includes drug reviewers, senior scientists, and career officials who collectively represent decades of institutional knowledge about how drugs get approved.
Former commissioner Scott Gottlieb estimated that as many as 600 drug reviewers have had to recuse themselves from approval decisions because they're actively interviewing with pharmaceutical companies. Six hundred. That's not a trickle; it's a talent exodus.
Why Everyone Is Leaving at Once
The FDA's leadership chart looks like a game of musical chairs where someone keeps removing seats. In the past year, the agency has cycled through commissioners, lost its CDER (drug review) director multiple times, and watched the head of CBER (the biologics and gene therapy center) depart alongside other senior figures.
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The current lineup is heavy on "acting" titles: acting commissioner Kyle Diamantas, acting CDER director Michael Davis, acting CBER director Karim Mikhail. In government, "acting" is often code for "temporary and uncertain." These roles carry a 210-day legal limit on authority, which means more turnover could be right around the corner.
Budget cuts and reorganizations have made the situation worse. Staff workloads are heavier. Morale, by most accounts, is in the basement. And the private sector is waving around significantly bigger paychecks. It's the regulatory equivalent of a star player demanding a trade from a losing team.
Why Biotech Companies Are Thrilled (Quietly)
No biotech CEO is going to publicly celebrate the FDA falling apart. That would be terrible PR, and also, they need the agency to actually function so their drugs can get approved. But behind closed doors? The hiring frenzy tells the story.
Former FDA officials are landing in three main buckets:
C-suite and leadership roles. Think chief medical officer, chief scientific officer, or (like Hahn at Turn Therapeutics) executive regulatory leads. These hires bring an intimate understanding of how FDA review teams think, what evidence they find persuasive, and which red flags trigger delays.
Board and advisory positions. Senior FDA alumni are getting invited onto corporate boards and scientific advisory panels. It's lucrative, strategic, and lets them influence multiple companies at once.
Consulting and lobbying. Some officials launch boutique regulatory firms or join established ones. Their clients: biotech companies approaching major milestones who need someone to whisper, "The FDA will hate this; do it differently."
For a company like Turn Therapeutics, bringing in Hahn isn't just about prestige. A phase 2 eczema program needs to eventually convince FDA reviewers that its data package is solid enough for approval. Having someone who used to sit on the other side of that table is like having a former opposing coach join your team right before the playoffs.
The Bigger Picture: Uncertainty Is the New Normal
Wall Street is paying close attention. Analysts at firms like RBC have noted that biotech investing requires long-term regulatory visibility, and the current leadership churn is actively undermining it. When you can't predict who will be reviewing your drug, or what standards they'll apply, it gets harder to model approval odds. That uncertainty can depress valuations and delay financings for early-stage companies.
The irony is thick. The FDA under former commissioner Makary introduced several biotech-friendly initiatives: compressed review timelines, openness to approving drugs based on a single pivotal trial instead of two, and new pathways for ultra-rare diseases. Some of those reforms were genuinely forward-thinking. But with Makary gone and his successors still finding their footing, nobody knows which of those policies will survive.
The result is a strange paradox. The FDA's instability is bad for the industry overall (slower reviews, less predictable feedback, weaker guidance on novel therapies). But for individual companies that can recruit former insiders, it's a competitive advantage. The institutional knowledge walking out the FDA's front door is walking into biotech's back door.
What Smart Companies Are Doing Right Now
Biotechs approaching key regulatory milestones in 2026 and 2027 aren't just hoping for the best. The sharpest ones are adapting their playbooks:
They're building their evidence packages to over-deliver, anticipating that reviewers with less experience or bandwidth may default to "we need more data" rather than engaging with nuanced arguments.
They're leaning hard on precedent, identifying 10 or 20 similar drugs that have already been approved and framing their submissions as natural extensions of decisions the FDA has already made. When the agency is in flux, familiar patterns feel safer to reviewers.
And they're adding timeline buffers of three to nine months on critical milestones, because the days of predictable review clocks may be on pause.
Gene and cell therapy companies are the most exposed. The loss of champions like former CBER director Peter Marks, who aggressively pushed novel pathways for rare diseases, means those programs face a more cautious, less experienced review environment. For small-molecule drugs with extensive precedent, the disruption is milder.
The Talent War Nobody Talks About
The FDA revolving door has always raised ethical questions. Stanford Law School researchers have called it a "persistent source of undue influence," pointing to controversial approvals like Aduhelm (Biogen's Alzheimer's drug) and Exondys 51 (for Duchenne muscular dystrophy) as cases where the line between regulator and industry blurred uncomfortably.
Those concerns haven't gone away. If anything, the sheer volume of departures in 2025 and 2026 has amplified them. Watchdog groups are calling for longer cooling-off periods and tighter disclosure rules. Reform proposals exist on paper, but in the current political environment, enforcement is another story.
Meanwhile, Hahn settles into his new office at Turn Therapeutics, GX-03 moves through its phase 2 trial, and the FDA tries to figure out who's left to review it. The revolving door keeps spinning. The only question is how fast.
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