The U.S. Food and Drug Administration (FDA) announced it will not accept regulatory submissions that require user fees during the ongoing government shutdown, which began October 1 after Congress failed to reach a funding agreement. While the agency will continue to conduct mission-critical activities, the pause underscores the vulnerability of regulatory operations during federal funding lapses.
What Continues During the Shutdown
According to FDA, essential public health activities will remain operational. These include responding to emergencies such as foodborne illness outbreaks, supporting high-risk food and medical product recalls, monitoring imports, and conducting surveillance of medical devices and other products with significant safety concerns. Civil and criminal investigations tied to product safety will also continue.
FDA’s contingency plan, released September 25, indicated that 86% of staff—approximately 13,872 employees—will remain on duty. Of these, two-thirds are funded through alternative mechanisms and nearly one-fifth are excepted due to roles deemed necessary to protect human life. Routine activities, however, such as food inspections, guidance development, database analysis, and administrative support functions, will be curtailed.
Regulatory Submissions on Hold
The most significant operational impact is the halt of submissions that require user fees, including new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). Under federal law, FDA does not have the authority to accept user fees during a funding lapse. This restriction will remain in place until either an appropriations bill or a continuing resolution restores funding.
For sponsors, the implications are serious: timelines for approvals, labeling changes, and other regulatory actions could be delayed. This is particularly challenging for companies with critical therapies in development or pending review, as even short delays can disrupt launch planning and market access.
Broader Government Impact
The Department of Health and Human Services (HHS), FDA’s parent agency, will also see a major impact. Of its nearly 80,000 employees, more than 32,000 will be furloughed. While agencies like FDA are structured to retain a larger proportion of their workforce, the disruption to routine operations will be felt across the healthcare system.
Regulatory experts note that compared to agencies providing direct patient care—such as the Veterans Affairs healthcare system or the NIH Clinical Center—FDA is less acutely impacted. However, the loss of momentum in non-critical functions, like guidance development and long-term research, can have lasting effects even after operations resume.
EMMA International’s Perspective
At EMMA International, we recognize that funding lapses and shutdowns create uncertainty not only for regulators but also for the life science companies that depend on timely FDA interactions. Delays in submissions, reviews, or guidance updates can ripple through development programs and supply chains.
Our team helps clients prepare for these risks by strengthening regulatory strategies, ensuring submission readiness, and planning contingencies for potential disruptions. With a proactive approach, companies can minimize the impact of regulatory slowdowns and remain aligned with long-term compliance and product goals.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
Reference
Eglovitch, J. S. (2025, October 1). Shutdown: FDA will not accept submissions until funding resumes. Regulatory Affairs Professionals Society.m to learn more.
