Biotech's Most Wanted Man Doesn't Even Want the Job

He joined the FDA in 1999 after a career in academic oncology at MD Anderson Cancer Center. Over the next quarter century, he transformed how the U.S. reviews and approves cancer drugs. He became the first director of the Oncology Center of Excellence in 2017, a unit that broke down the agency's internal silos by unifying the review of cancer drugs, biologics, and certain devices under one roof.

Under his watch, the FDA launched Project Orbis (letting multiple countries review cancer drugs simultaneously), Project Facilitate (a hotline to help doctors navigate compassionate use), and Project Renewal (updating dusty old drug labels to reflect modern evidence). He's authored or co-authored more than 800 scientific publications.

The man is, by any measure, one of the most accomplished regulatory officials alive.

But he left in December 2025, reportedly frustrated by growing political interference in scientific decisions and the chaos swirling through the agency. He'd briefly taken over as head of CDER (the Center for Drug Evaluation and Research, which oversees all drug approvals) at Makary's request, only to file retirement papers weeks later.

Now the industry wants him back.

300 Signatures and a Simple Message

The open letter, organized through the patient advocacy group No Patient Left Behind, has drawn more than 100 signatories. The list reads like a who's who of biotech: CEOs from companies like Ultragenyx, Tyra Biosciences, and Synthekine; investment firms including Deerfield Management and RA Capital Management; oncologists; clinical researchers; and patient groups.

Their core argument is straightforward. Drug development takes a decade or more. Companies and investors make billion-dollar bets based on the assumption that regulatory standards will stay consistent. When the FDA starts changing the rules mid-game (rejecting applications that would have been approved six months earlier, reversing guidance without public comment), the entire system seizes up.

The letter doesn't mince words, describing "staff exodus," "missed deadlines," and "eroding scientific predictability."

But the signatories are also careful to frame this as more than a fan letter. They say they're endorsing a set of criteria for any FDA leader: deep regulatory experience, a track record of reform, and the spine to resist political pressure without sacrificing efficiency. They just happen to think Pazdur is the only person who checks every box.

The Money Is Already Moving

This isn't just philosophical hand-wringing. Investor behavior is shifting in real, measurable ways.

Surveys of biotech investors show that the "vast majority" have already changed how they allocate capital because of FDA instability. Some are pulling back from categories most exposed to regulatory whiplash, particularly gene therapy and vaccines. Others are looking at drug development opportunities outside the U.S., in countries where the regulatory environment feels more predictable.

That last point should alarm anyone who cares about American competitiveness in biotech. For decades, the U.S. has been the world's premier destination for drug development, largely because the FDA was seen as rigorous, fair, and stable. If that reputation erodes, the capital follows, and so do the jobs, the clinical trials, and eventually the cures.

The Pazdur campaign is, at its core, a bet that one appointment could reverse the confidence spiral.

The Catch: Does He Even Want It?

This is where the story gets complicated. Multiple reports note uncertainty about whether Pazdur is actually interested in the job. He's declined senior roles before (he initially turned down the CDER directorship in 2025). He retired from an agency he clearly loved because the political environment became unbearable.

Asking him to walk back into that same environment, now arguably worse, is a big ask. The FDA commissioner doesn't just deal with science; the role requires navigating White House politics, congressional hearings, and industry lobbying on everything from drug pricing to artificial intelligence in clinical trials. It's a confirmation process that runs through the Senate HELP Committee, and senators will grill any nominee on hot-button issues from reproductive health to tobacco regulation.

For a scientist who spent 26 years focused on getting cancer drugs to patients, the political theater might be a dealbreaker.

What Happens Next

The acting commissioner's clock is ticking. The FDA has no permanent head.

Whether or not Pazdur says yes, the campaign itself sends an unmistakable signal: the biotech industry is scared. Not of tough regulation, but of unpredictable regulation. The sector can work with strict standards; what it can't work with is standards that shift depending on who's in charge this month.

The names on that letter aren't just asking for a new commissioner. They're asking for the FDA to be the FDA again.

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