The FDA Is Running Out of People Who Know How to Approve Your Drugs

Today, both major drug review centers (CDER and CBER) are led by acting directors. There is no confirmed commissioner. No confirmed deputy commissioner. The agency responsible for evaluating every new drug in America is, in a very real sense, running on autopilot.

The DOGE Effect

Much of this traces back to the Department of Government Efficiency (DOGE) and broader HHS restructuring. The FDA lost roughly 3,500 positions, about 17% of its total workforce. HHS as a whole planned to cut 20,000 roles, around 25% of the department.

A hiring freeze compounds the problem: agencies can bring on only one new employee for every four who leave. So even if CDER wanted to rebuild, the math works against it. Workforce analysts estimate that with combined CDER/CBER headcount dropping from about 7,400 to 6,100, the remaining staff would need to be 20% more productive just to maintain prior output. Experts describe that expectation as unrealistic.

FDA leadership has pushed back on the darkest interpretations, with Makary (before his resignation) stating that cuts targeted administrative and support roles, not scientists or reviewers. But industry lawyers note that those "support roles" include project managers, policy staff, and compliance officers: the people who keep reviews moving on schedule. Cutting them is like firing the offensive line and telling your quarterback he should be fine.

Why This Matters for Every Drug in the Pipeline

CDER received more than 3,000 new investigational drug applications in 2025, along with roughly 12,300 clinical trial protocols (600 more than the year before) and over 4,500 meeting requests. Volume is going up while capacity is going down. That's a traffic jam waiting to happen.

The most complex applications are especially vulnerable. Cell and gene therapies, which require deep scientific expertise to evaluate, have already shown signs of strain. An Alliance for Regenerative Medicine snapshot found that the rejection rate for cell and gene therapies rose from 18% to 38%. Multiple approvals have been delayed into 2026 as the FDA requested more data or extended review timelines.

CDER's own track record was already wobbling before the exodus: in 2023, a record 11% of applications missed their PDUFA goal dates, the deadlines Congress sets for the agency to act on drug applications. That was before the workforce fell off a cliff.

Polsinelli attorney Chad Landmon noted that Pazdur's abrupt retirement roughly seven weeks into his director role "didn't give folks in the drug industry a lot of comfort." Hogan Lovells has urged sponsors to run scenario planning around CDER staffing impacts. Capital Alpha called the preceding 13 months "the most damaging period in FDA history."

Small Biotechs Have the Most to Lose

For a Pfizer or a Roche, a six-month delay is expensive but survivable. For a small biotech burning $10 million a quarter with a single drug in the pipeline, an unpredictable FDA timeline can be existential.

DelveInsight analyst Aparna Thakur identified the "massive workforce reduction" as the most disruptive trend facing the industry, emphasizing that reliable, timely FDA action is critical for smaller companies that can't absorb long delays. When your stock price is pinned to a PDUFA date and that date becomes a question mark, investors get nervous. And nervous investors close their wallets.

A Glimmer of Regulatory Pragmatism

To its credit, the FDA hasn't been entirely passive. In May 2026, CBER finalized guidance loosening manufacturing requirements for cell and gene therapy applications, including flexibility around how many validation batches sponsors need to produce. In June, a draft guidance proposed letting gene therapy developers reuse existing scientific data from similar products, potentially reducing duplicative review work.

These are smart moves that could ease some of the pressure. But streamlined paperwork only helps if there are enough people to read it.

The Bottom Line

The FDA is trying to review more drugs, with fewer people, less experienced leadership, and a hiring system that replaces one person for every four it loses. The agency issued new guidances to speed things up for complex therapies. That's encouraging. But policy documents don't review applications; people do.

Rebuilding the kind of institutional knowledge that just walked out the door will take years, not quarters. And every month of uncertainty adds risk for patients waiting on new treatments, for companies planning around regulatory milestones, and for an industry that depends on a credible, functioning FDA.

The lights are still on at CDER. The question is whether anyone's left to answer the door.