The Impact Of A US Government Shutdown On The Food And Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown.

With a potential U.S. government shutdown looming in March 2024, key healthcare agencies, including the FDA, may face significant operational impacts. Congress must decide on funding by March 1 for the FDA and VA, and by March 8 for HHS. If the shutdown proceeds, nearly 20% of FDA employees will be furloughed, with around 64% retained due to exempt funding and an additional 17% working on critical health-related tasks. The reduced staffing could hinder FDA’s ability to meet standard review timelines, possibly impacting the submission of marketing applications and other regulatory communications.

FDA funding sources such as user fees may temporarily sustain certain operations like new product approvals, clinical research reviews, and guidance publication. However, the FDA cannot accept new user fees during the shutdown, affecting applications with unpaid fees. Although most user fee-funded activities may proceed near normal timelines, general correspondences and items not covered by user fees could face delays.

Effective communication remains critical for ongoing product development, and ProPharma’s regulatory experts provide valuable support to mitigate potential disruptions. With over 40 years of experience, including navigating past shutdowns, ProPharma helps sponsors maintain open communication with FDA divisions, project managers, and directors, ensuring good-standing relationships and progress during reduced FDA availability.

ProPharma’s expertise in regulatory pathways enables clients to effectively manage uncertainties during a shutdown, safeguarding program timelines and maintaining a proactive approach to FDA interactions. For personalized guidance, connect with ProPharma’s regulatory consulting team today.