The FDA's Gene Therapy Brain Drain Is Getting Worse

These aren't simple pills. Gene therapies involve viral vectors, genetic editing, and manufacturing processes so intricate that a single misstep can derail a product. Reviewing them requires deep scientific expertise, and that expertise takes years to build.

Which brings us to the real problem: CBER lost 224 employees in fiscal year 2025, after posting a net gain the year before. More than half of those departures came in the final quarter alone, suggesting a concentrated exodus rather than normal turnover. Reports describe "many losses at the branch chief, division director, even office director positions" within OTP's clinical review teams.

Across the entire FDA, the damage was even broader. Reuters reported in June 2026 that the agency had cut more than 3,000 employees the prior year and was authorized to hire back 2,200. But hiring authorization and actually filling seats with experienced gene therapy reviewers are very different things. You can't replace 15 years of institutional knowledge with a job posting.

The Approval Bottleneck Is Already Showing

The strain is visible in the numbers. Total CBER biologics approvals dropped to 21 in 2025, down from 24 the year before. The rate of rejections (complete response letters) for gene therapy applications has also climbed steeply: roughly 38% of FDA decisions on cell and gene therapy products resulted in a rejection over a recent 15-month period, compared to about 18% over 2020–2024.

That doesn't necessarily mean the FDA is being hostile to gene therapies. It could mean reviewers are stretched thin, or that less experienced staff are defaulting to caution. Think of it like a restaurant that lost its head chef and sous chef on the same night: the food still comes out, but it takes longer, and more dishes get sent back.

Sponsors are already feeling it. Industry insiders describe meetings with FDA staff as "more cursory," reflecting limited bandwidth. Clinical review teams are dealing with high workloads and fewer experienced leaders. And for combination products (therapies that include both a biological component and a medical device), staffing cuts at the device review center, CDRH, are adding another layer of friction.

Not All Doom and Gloom

Before you panic: some analysts actually see reasons for cautious optimism.

In June 2026, the FDA issued a draft guidance encouraging sponsors to reuse "prior scientific knowledge" in their manufacturing submissions, a move widely interpreted as industry-friendly. Barclays analyst Eliana Merle pointed to recent decisions, like the FDA reversing a prior rejection to support an accelerated approval pathway for a Hunter syndrome gene therapy, as evidence of "increased flexibility." Raymond James' Sean McCutcheon called the revised stance "significantly more flexible."

The agency also removed certain post-market safety restrictions (called REMS) from six CAR-T products in 2025, signaling a willingness to reduce bureaucratic barriers for approved therapies. And on the manufacturing side, OTP's CMC (chemistry, manufacturing, and controls) leadership has remained relatively stable, providing at least one pocket of continuity.

The expert consensus, as much as one exists, is that the leadership vacuum creates uncertainty and friction, not an outright freeze. Well-prepared programs with robust data will still get through. Marginal ones will face more hurdles.

What's at Stake in the Next 18 Months

The pipeline coming at the FDA doesn't care about staffing charts. Multiple gene therapies have PDUFA dates (the deadlines by which the FDA must make a decision) scheduled throughout 2026, covering conditions from Hunter syndrome to glycogen storage disease to retinitis pigmentosa. Looking further ahead, 2027 could bring the first-ever CAR-T approval for an autoimmune disease, and possibly the first in vivo gene editing therapy to cross the finish line.

One estimate suggests around 40 cell and gene therapies could receive FDA approval in 2026–2027 combined, though historically the actual pace has been closer to 5–7 per year. The gap between pipeline potential and regulatory capacity is the whole story right now.

The FDA built OTP as a "super office" specifically to handle this surge. It was supposed to have six sub-offices, new supervisory positions, and a hiring pipeline fueled by PDUFA fees that would add more than 100 new staff. That was the plan.

Instead, the office is running on fumes, led by acting officials, and hemorrhaging the very people who know how to evaluate whether a gene therapy is safe enough to inject into a patient's brain or bloodstream. The science keeps advancing. The question is whether the FDA can keep up.

The FDA Fired Thousands of People. Now It's Hiring 2,200 Back.

The FDA slashed 3,000 workers last year. Now it's scrambling to hire 2,200 back, but the math still doesn't add up. Here's what it means for drug approvals, biotech timelines, and whether the regulatory engine can survive the whiplash.