FDA cuts staffing jeopardize food and drug safety inspections

In early April 2025, the Food and Drug Administration (FDA) faced significant staffing cuts impacting its inspection capabilities, as approximately 170 employees were laid off from the Office of Inspections and Investigations. This reduction was part of a broader plan initiated by the Department of Health and Human Services, which indicated that around 10,000 workers across various health agencies would be let go. Although the HHS claimed that direct cuts to the FDA's inspections staff were not intended, meetings among FDA leadership revealed concerns regarding the management and administrative staff's absence, which traditionally supported the inspectors in the field. As a result of these layoffs, the FDA's ability to conduct routine surveillance inspections is expected to decline, necessitating a focus shift towards more urgent issues, such as inspecting firms identified with safety risks or following up on previous violations. Additionally, the loss of the travel operations division, responsible for logistics and coordinating inspections internationally, led to significant operational disruptions, as front-line inspectors would spend more time on administrative tasks rather than field inspections. The pause of a pilot program aimed at unannounced foreign inspections amplifies concerns regarding global food and drug safety, hindering timely responses to potential crises. The agency has historically struggled to meet its inspection goals, and the current layoffs compound the existing challenges triggered by a backlog from the COVID-19 pandemic. Reports from the Government Accountability Office indicated that there was already a growing list of overdue inspections. Further complicating the situation was the introduction of strict spending limitations on government-issued cards, which limited expenditures to $1, leading to considerable delays in inspection planning. Consequently, inspectors were required to schedule their inspections a month in advance. Furthermore, within the FDA, more top officials responsible for vaccine regulation vacated their positions, exacerbating issues related to the agency’s capacity to review and approve new vaccines and drugs. Notably, the departure of key personnel from the Center for Biologics Evaluation and Research, including the agency’s top vaccine regulator Dr. Peter Marks, signifies a weakening of public health infrastructure at a time when vaccine research and approvals are critical, especially given the ongoing bird flu crisis. As the FDA struggles with its workforce challenges, public health experts warn of the adverse effects these layoffs will have on the safety and efficacy of food and drug regulations that directly impact American consumers.