The FDA's Drug Review Machine Is Running Out of People

And here's the part that should worry anyone waiting on a drug approval: user-fee hiring under PDUFA VII and BsUFA III stood at zero percent completion through the third quarter of fiscal 2026. These are the positions specifically funded by industry fees to review drug and biosimilar applications. Zero. Not slow. Not behind schedule. Zero.

Five Directors in a Year (No, Really)

Staff departures are one thing. Leadership chaos is another.

CDER has cycled through five directors since January 2025. Patrizia Cavazzoni stepped down that month after nearly four years. Her replacement, Jacqueline Corrigan-Curay, served in an acting capacity until July. George Tidmarsh lasted from July to November. Richard Pazdur, the legendary oncology chief, took over on November 11 and retired by the end of December, barely three weeks later.

Tracy Beth Høeg was appointed acting director in early December 2025, only to be fired in May 2026. Career official Michael Davis now holds the role on an acting basis.

At the commissioner level, Marty Makary resigned on May 12, 2026, replaced by Acting Commissioner Kyle Diamantas.

Biopharma strategist Graig Suvannavejh called CDER "the single most important agency that exists at FDA" and described five directors in one year as "not acceptable." Attorney Chad Landmon noted that Pazdur's ultra-short tenure "didn't give folks in the drug industry a lot of comfort."

The Work Isn't Getting Simpler

All of this is happening while the FDA's inbox gets heavier and harder.

The pipeline for the second half of 2026 includes multiple gene therapy applications, novel biologics, and complex oncology drugs; products that demand deep, specialized expertise from the exact kind of experienced reviewers the agency keeps losing.

The cumulative portfolio of 347 accelerated approvals also requires ongoing monitoring, confirmatory trials, and potential withdrawal decisions. Think of it like a restaurant that not only has to cook new dishes but also keep checking on every table it's ever served.

Somehow, CDER has managed to keep the lights on. In 2025, the center approved 46 novel drugs and met its review deadlines for 96% of them. But analysts at Raymond James warn that one-for-one replacement of departed reviewers doesn't restore lost institutional knowledge. Chris Meekins wrote that new hires are likely to review applications more cautiously as they learn the ropes, slowing practical timelines even when official deadlines are technically met.

Why This Matters Beyond Washington

A congressional letter from Representative Kevin Mullin laid it out plainly: losing seasoned staff with "highly specific expertise and institutional knowledge" could set the agency "back a decade plus." Companies are reportedly struggling to anticipate what the FDA will ask of them during the review process, creating what the letter described as "a culture of inconsistent leadership seemingly driven by politics."

The downstream effects are already showing up in boardrooms and investor models. Smaller biotechs, the ones that can't absorb months of regulatory uncertainty, face the biggest squeeze. DelveInsight analyst Aparna Thakur called the workforce reduction "the most disruptive trend by far" for biopharma stakeholders, adding that she "would love to see the FDA return to full staffing levels," especially for "smaller companies who can't afford long delays or ambiguity."

Some members of Congress have warned that the instability could push drug development investment out of the United States entirely. Representative Pallone cautioned that upheaval in user-fee programs "will further hasten the movement of investment in medical product development out of the United States."

The Bottom Line

CDER isn't collapsing tomorrow. Drugs are still getting approved. Deadlines are mostly being met. But the agency is running on fumes and institutional muscle memory, staffed well below where it was just 18 months ago, led by acting officials, and facing an application pipeline that's getting more complex by the quarter.

The question isn't whether the FDA can survive one bad year. It's whether it can survive several in a row without something breaking. For every biotech founder waiting on a PDUFA date, every patient counting on a new therapy, and every investor pricing in a regulatory timeline, the answer to that question is worth a lot more than a headline.

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