The 2025 FDA Shutdown: Essential Functions Continue, But Innovation Slows

2 min read

The 2025 U.S. government shutdown, which began at 12:01 a.m. ET on October 1, triggered a significant operational shift at the Food and Drug Administration (FDA). With Congress failing to pass a funding bill for fiscal year 2026, the FDA entered contingency mode, halting many routine and regulatory functions while preserving its core public health responsibilities.

What Was Paused

Due to the lapse in appropriations, the FDA suspended several non-essential activities, particularly those dependent on user fees. These include:

Acceptance of new drug, biologic, and medical device applications that require user fee payments.
Routine inspections and advisory meetings.
Non-urgent communications and stakeholder engagement.
Long-term policy development and scientific research.
Hiring and recruitment efforts.
Routine food safety oversight not deemed critical.

These pauses reflect the constraints imposed by the Anti-Deficiency Act, which prohibits federal agencies from incurring obligations without appropriated funds unless the activity is deemed essential to human life or property.

What Continued

Despite the shutdown, the FDA maintained , funded by carryover user fees and other exempt sources. These include:

Emergency response and outbreak management.
Drug shortage mitigation and safety surveillance.
Recall coordination and import screening.
"For cause" inspections where imminent threats to public health are suspected.
Ongoing review of previously submitted applications, though these may face delays due to reduced staffing.

These activities are protected under exceptions in the Anti-Deficiency Act and are vital to maintaining public trust in the safety of the U.S. food and drug supply.

Funding Realities

The FDA’s ability to operate during the shutdown hinged on —funds collected in previous fiscal years for specific programs. While this allowed some continuity, these reserves are finite. A prolonged shutdown could exhaust these funds, forcing further cutbacks or halts in even critical operations.

Industry Impact

The shutdown’s ripple effects were quickly felt across the life sciences sector:

Companies could not submit new applications for product approvals that require user fees, delaying innovation pipelines.
Ongoing reviews slowed due to limited staff availability and operational bottlenecks.
Regulatory uncertainty increased, complicating planning for product launches and compliance timelines.

While the FDA’s core safety functions remained intact, the broader regulatory ecosystem experienced a slowdown, with potential long-term implications for public health innovation and market readiness.

Conclusion

The 2025 FDA shutdown underscores the delicate balance between fiscal policy and public health infrastructure. While the agency’s contingency planning ensured that essential safety functions continued, the halt in new submissions and routine oversight introduced significant friction into the regulatory process. If prolonged, such shutdowns risk not only delaying innovation but also eroding the predictability that industry and consumers rely on.