The short version
FDA is issuing more Warning Letters than it did a year ago. At the same time, FDA itself has fewer people to write and follow up on them, and the pharma/biotech companies receiving them have fewer people watching for them. That combination — rising enforcement volume, shrinking headcount on both sides — is why manual FDA monitoring (a bookmarked fda.gov tab, a Friday scrape, an intern's Google Alert) is getting harder to sustain in 2026, not easier.
Enforcement volume is up, and it isn't a blip
FDA issued 303 Warning Letters to drug and biologics firms in fiscal year 2025, up from 190 in FY2024 — a 59% increase. A senior FDA official told regulatory trade press that the Center for Drug Evaluation and Research's (CDER) own letter count rose roughly 50% over the same period, with data-integrity and unapproved-drug citations driving much of the increase (RAPS, Dec 2025).
The pace didn't slow going into 2026. CDER added roughly 30 more Warning Letters by early March and another 25-letter tranche by mid-June, according to trade coverage tracking the agency's public Warning Letters database. Notably, this continued after FDA Commissioner Marty Makary resigned in May 2026 amid internal tensions with the White House, with Kyle Diamantas serving as acting commissioner (NPR, CBS News) — a sign the enforcement surge is structural, tied to agency posture rather than one commissioner's personal agenda.
FDA has fewer people to run that enforcement
The increase in Warning Letters is happening as FDA's own workforce has shrunk. Reporting tied to the Department of Government Efficiency (DOGE) restructuring at HHS puts FDA's 2025 staff reductions at roughly 3,859 employees, with hundreds more departures in early 2026 (FedScoop). Law-firm client alerts tracking the cuts note that separated FDA inspectors averaged 19 years of experience, and that the agency remains meaningfully understaffed against its own inspection targets even after some positions were later reinstated (Morgan Lewis; Skadden; ProPublica). Fewer experienced staff generally means slower routine work and a sharper bias toward the highest-signal enforcement action FDA has — the Warning Letter — which is exactly the document volume that's climbing.
Compliance teams inside pharma and biotech are shrinking too
The squeeze isn't limited to the regulator. Pharma and biotech companies cut more than 14,180 jobs across 25-plus companies in just the first half of 2026, driven by trial failures, patent-cliff pressure, and cost restructuring (layoff tracking, H1 2026; PharmaVoice). Quality and compliance functions haven't been walled off from that — Novo Nordisk's broader workforce reduction, for example, included cuts to quality-control and technical staff at a U.S. plant. Industry commentary has flagged the resulting risk directly: cutting a QMS manager or compliance lead removes the paycheck, not the regulatory obligation the role existed to cover (pharmaphorum).
What this means for how you monitor FDA enforcement
Put the three trends together and the conclusion is arithmetic, not opinion: more Warning Letters, a leaner FDA writing and following up on them, and leaner compliance teams reading them on the receiving end. A once-a-week manual scrape of fda.gov's Warning Letters listing was a reasonable process when volume was lower and teams were fuller. At FY2025-2026 volume, with fewer analyst-hours available on both sides of the transaction, that same process means a longer lag between publication and your team actually reading a letter that touches your watchlist — a CDMO, a competitor, a therapeutic area.
Argus exists for that gap. It reads every Warning Letter FDA publishes and delivers the ones matching your watchlist by 6am ET the next business day, with severity, citations, and a verbatim link back to fda.gov on every item — so a leaner team still reaches Monday's standup informed instead of catching up.
Sources
- RAPS — "FDA official: CDER warning letters up 50% in FY 2025" (Dec 2025)
- NPR — "FDA Commissioner Marty Makary resigns after tumultuous tenure" (May 2026)
- FedScoop — "FDA tech officials complied with DOGE's requests for data. The staff reductions still came."
- Morgan Lewis — "FDA Drug Inspections Post-Workforce Reductions"
- ProPublica — "FDA Cuts Will Limit Scrutiny of Troubled Foreign Drug Factories, Inspectors Say"
- PharmaVoice — "Biopharma layoffs surged last year, but 2026 is a chance to turn the page"
- pharmaphorum — "The hidden risks of biotech layoffs"
Figures above are as reported by the cited outlets at time of publication and may be revised as FDA and HHS release updated workforce and enforcement data.