FDA’s Oversight and Funding Expand, But Staffing Challenges Persist

A recent report from the U.S. Government Accountability Office (GAO) indicates that the Food and Drug Administration (FDA) has seen a significant increase in its oversight responsibilities and funding from fiscal year 2008 through fiscal year 2024. This expansion has encompassed a growing range of consumer products, from food and medical items to tobacco and cosmetics, with the FDA’s purview accounting for a substantial portion of consumer spending.

During the period under review, the FDA’s mandate broadened considerably. In 2009, the agency gained the authority to regulate new product categories, including cigarettes and other tobacco products. Subsequently, in 2011, federal law mandated an increase in the number of required food safety inspections. More recently, in 2022, the FDA’s regulatory powers over cosmetics were enhanced to include recall capabilities for specific products. These evolving responsibilities reflect a dynamic regulatory landscape designed to protect public health and safety.

The report also highlights a notable shift in the FDA’s funding structure. Over the 17-year span from fiscal year 2008 to fiscal year 2024, the agency’s overall funding experienced growth, driven significantly by user fees. These fees are collected from the manufacturers and other entities that the FDA regulates. Consequently, the agency’s financial reliance has transitioned from being primarily funded by discretionary appropriations, referred to by the FDA as budget authority, to a nearly equal balance between these appropriations and user fees. This increase in user fee revenue stems from both the authorization of new user fees, such as those for tobacco products, and the growth of existing user fees, like those associated with human drugs.

Despite these increases in funding and expanded responsibilities, the FDA has encountered persistent challenges related to its workforce. The GAO report indicates that the agency has struggled with the recruitment, retention, and training of its staff. These human capital issues have, in turn, impacted the FDA’s capacity to conduct necessary inspections. For instance, in 2024, staffing shortages meant the agency was unable to complete as many drug manufacturing facility inspections as it had in previous years. Beyond inspection capacity, the FDA has also faced difficulties in managing other critical resources, including its information technology systems used for collecting data on safety and quality complaints, according to reports issued between January 2020 and January 2025. The GAO has previously issued recommendations to address these challenges, and while the FDA has acknowledged these recommendations and is taking some steps, most have not been fully implemented as of December 2025.

Article by Mel Anara, based upon information from the U.S. Government Accountability Office

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