US Government Shutdown Threatens to Stress an Already Depleted FDA
The U.S. government officially shut down as of 12:
01 a.m., October 1, 2025, due to a funding impasse in Congress23.
During the shutdown, the FDA cannot accept any new drug applications because it cannot collect user fees required to process them15.
Roughly 86% of the FDA’s staff will be retained during the shutdown. Most are covered by carryover user fees or are performing essential public health activities1.
The FDA was already under strain in 2025 following massive workforce cuts earlier in the year, with some 3,500 full-time positions eliminated14.
Expected impacts include further delays in drug approvals, compounding the effects of prior staff reductions and slowing innovation and patient access to new treatments1.
This shutdown will not affect all FDA activity equally:
essential functions related to imminent threats to public health and those funded by existing user fees will continue17.
The duration of the shutdown remains uncertain, with some analysts warning it could last up to a month if no legislative compromise is reached soon1.
Sources:
1. https://www.biospace.com/policy/fda-delays-likely-as-federal-government-hurtles-toward-shutdown
2. https://abcnews.go.com/Politics/us-government-shut-midnight/story?id=126067361
3. https://tonko.house.gov/shutdown2025/
4. https://www.fiercepharma.com/pharma/fda-appears-avoid-worst-amid-government-shutdown-review-application-hurdles-remain
5. https://www.raps.org/news-and-articles/news-articles/2025/10/shutdown-fda-will-not-accept-submissions-until-fun