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# What Happens to FDA in a Budget Shutdown?
- URL: https://www.fdaweb.com/what-happens-to-fda-in-a-budget-shutdown/
- Published: 2025-02-19T12:00:00.000Z
- Updated: 2026-09-14T14:53:30.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5158686

In a Hyman, Phelps & McNamara *FDA Law Blog* post, principal regulatory device and biologics expert **Richard Lewis**, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The [post](https://www.thefdalawblog.com/2025/02/what-to-expect-when-you-are-expectinga-government-shutdown/?ref=fdaweb.com) recognizes that the government is now funded through 3/14 and will shut down after that unless there is a new budget or continuing agreement in place.

Lewis writes that staff in positions that are exempt from appropriations may be asked to remain working even if other employees are furloughed. CBER, CDER, and CDRH are largely funded through user fees, he says, and submissions under the various user fee agreements can continue in process. He says that in 2018-2019, reviewers with active user fee files continued their jobs without interruption.

The post makes these additional points:

- a short or moderate agency shutdown should not make a meaningful change to the review of NDAs, BLAs, PMAs, 510(s), IDEs, and INDs;
- written response meetings and teleconferences should proceed, but face-to-face meetings may not be possible due to support staff furloughs;
- most normal surveillance operations are funded by congressional appropriations and thus would be shut down; and
- while submissions to FDA that have an associated user fee will not be accepted during a shutdown because the agency has no way to process the company payment, submissions not associated with a user fee will be accepted and reviewed.