The FDA Lost 4,000 Staff. Now What?

Commissioner Marty Makary called Høeg "the right scientist to fully modernize CDER." Industry leaders have expressed concern about the constant leadership churn at CDER and the regulatory uncertainty it creates.

Meanwhile, over at the Center for Biologics (CBER), vaccine chief Vinay Prasad is departing for the second time by end of April, after being fired and rehired earlier. His tenure included initially rejecting Moderna's mRNA flu vaccine (later reversed) and demanding a sham-surgery trial for UniQure's Huntington's gene therapy, a move that sparked public clashes with the biotech world.

The Approval Scoreboard

So has any of this actually affected drug approvals? The honest answer: a little, and probably more than the topline numbers suggest.

CDER approved 46 novel drugs in 2025, down from 50 in 2024 and 55 in 2023. That's not catastrophic; it's still above the 37 approvals in 2022 and the long-term average of about 38 per year since 2007. But the decline looks worse when you zoom into biologics. CBER approved just 9 BLAs (biologics license applications) in 2025, a notable decline from prior years.

The bigger issue isn't the count. It's the chaos behind individual decisions. Approvals have become unpredictable, with case-by-case political interventions muddying what used to be a fairly technocratic process. In Q3 of 2025, 11% of scheduled reviews were delayed, nearly triple the historical average of 4%. Companies that once planned their fundraising and commercial launches around predictable FDA timelines now have to build extra buffer into everything.

Biotech's Great Escape

When your home airport keeps canceling flights, you start driving to the next one over. That's essentially what's happening in drug development.

Biotech companies are increasingly pivoting to ex-US clinical trials, running studies in Australia, the EU, and the UK to get faster starts and avoid FDA-related bottlenecks. Analysts warn this strategy carries risks (work may need to be repeated for eventual US filing), but for cash-strapped biotechs burning through runway, waiting months for an IND review they used to get on schedule simply isn't an option.

RBC has identified the regulatory climate as a top concern among biotech investors. For smaller biotechs without deep pockets, a delayed approval isn't an inconvenience; it's an existential threat. Every extra month of uncertainty means more dilutive financing, more cash burn, and a higher chance the company simply runs out of time.

One Bright Spot (Maybe)

Not everything coming out of the FDA is grim. In February 2026, the agency issued draft guidance for a "Plausible Mechanism Framework" aimed at individualized genetic therapies. The idea: for ultra-rare diseases where you literally can't run a traditional clinical trial (because only a handful of patients exist worldwide), sponsors can seek approval based on a single well-controlled study, sometimes treating just one patient.

The therapy has to target a specific, well-understood genetic cause. Sponsors need solid natural history data from untreated patients, proof the treatment hits its molecular target, and evidence of clinical improvement. It's a thoughtful framework that could open doors for CRISPR-based therapies and antisense oligonucleotides (custom-built RNA drugs) targeting mutations so rare they'd otherwise never justify a development program.

Comments on the draft are open until late April 2026. If finalized, it could become one of the more meaningful regulatory innovations of this era, even amid the turbulence.

The Bottom Line

The Trump FDA is trying to do two things at once: shrink the government and speed up drug approvals. One year in, the shrinking is happening fast. The speeding up? Not so much. Review timelines are stretching. Leadership keeps turning over. Companies are hedging their bets by looking overseas.

The FDA has spent decades building a reputation as the world's gold-standard drug regulator. That reputation isn't a luxury; it's what makes global pharma companies want to file in the US first, what gives American patients early access to breakthrough therapies. Reputation, once lost, is extraordinarily hard to rebuild.

Four thousand employees and five CDER directors later, the experiment is running. The results are starting to come in. And the biotech industry is watching very, very closely.

The Eye Drug That Just Can't Take a Hint

Aldeyra Therapeutics just received its third FDA rejection for dry eye drug reproxalap, with regulators once again citing inconsistent efficacy data. The stock plunged over 70%, and Wall Street is running out of patience for a drug that keeps failing the same test.