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# Industry Sounds the Alarm on FDA Staff Cuts
- URL: https://www.fdaweb.com/industry-sounds-the-alarm-on-fda-staff-cuts/
- Published: 2025-04-02T12:00:00.000Z
- Updated: 2026-09-14T14:56:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158939

In the wake of dramatic [layoffs](https://www.fdaweb.com/fda-in-upheaval-as-staff-layoffs-begin/) at FDA this week, industry associations are busy sounding alarms as they weigh how the staff cuts will impact product development, FDA reviews and approvals.

The Pharmaceutical Research and Manufacturers of America questioned the cuts and their impact on the agency’s ability to maintain its gold standard regulatory reviews. “The rapid and substantial changes at FDA this week raise questions about the agency’s ability to fulfill its mission to bring new innovative medicines to patients,” the group said in a statement.

Generic drug maker lobbying group Association for Accessible Medicines (AAM) said it was “deeply concerned by reports that key officials within the FDA’s generic drug and biosimilar programs and officials responsible for administering the industry user fee programs were let go from the agency.” AAM said that while it supports improving FDA’s efficiency to help bring generic and biosimilar products to patients faster, many of the layoffs appear to do the opposite.”

Medical device lobbying arm AdvaMed reacted positively to reports that medical device reviewers and inspectors haven’t been affected by the staff cuts. However, the group said that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”

Meanwhile, the law firm Hyman, Phelps & McNamara’s drug regulatory expert **Naomi Lowy** prepared industry for missed user fee goals due to the layoffs. “Although reviews teams’ workload has not decreased, resources have,” she noted in an FDA Law Blog [post](https://www.thefdalawblog.com/2025/04/more-uncertainty-and-less-advice-from-fda-means-companies-will-need-to-even-more-carefully-chart-their-own-course-to-achieve-their-goals/?ref=fdaweb.com). “FDA leadership will inevitably need to make some difficult choices, including internal guidance on which assignments teams should prioritize and which can be temporarily or indefinitely delayed, or completely shelved.”

Additionally, Lowy predicted that industry will see a “less robust schedule of external meetings and slower pace of publications of guidance to industry” which can slow down advice to sponsors awaiting “information critical to inform their development programs.”