FDA’s parent HHS early last year set a goal of reducing staff by 3,500—it actually fell slightly more, to about 17,100, by year-end. Image: Tada Images/Shutterstock.com
By: FEDweek StaffThe FDA is facing a growing workload with a staff that was challenged to fulfill the agency’s responsibilities even before last year’s reductions by the Trump administration, the GAO has said.
The FDA’s responsibilities have grown in recent years as new types of products are brought onto the market—such as biosimilars—and its roles have expanded in areas traditionally under its purview, such as a 2023 law giving it oversight of cybersecurity standards for medical devices, it said. At the same time, “we and others reported that FDA faced staffing challenges related to recruiting, retaining, and training staff.”
“These reports have identified examples of FDA not having the capacity to meet, or facing potential challenges in meeting, its oversight responsibilities for multiple product areas,” it said, noting that FDA’s oversight of medical products and food safety are on its high-risk list.
Those reports documented impacts including reduced numbers of clinical research, drug manufacturing and food safety inspections, and delays in processing of product applications. They further documented difficulties in getting newly hired staff up to full performance level, which requires several years for positions such as clinical research investigators, food inspectors and medical technologies.
GAO noted that those findings were made even as FDA staffing grew over 2020-2024 from about 19,100 to 20,900—growth that was mostly funded from user fees, rather than from appropriated funds.
Further, FDA’s parent HHS early last year set a goal of reducing staff by 3,500—it actually fell slightly more, to about 17,100, by year-end—and reorganizing the agency.
“We don’t yet know the impact these cuts could have,” the GAO said in a related posting.
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