GAO Says FDA Staffing Gaps Have Cut Inspections as User Fees Near Half of Funding

The FDA's difficulty recruiting, retaining and training staff has reduced its capacity to conduct inspections, the Government Accountability Office said on February 3 in a report that tracks the agency's responsibilities, funding and workforce from fiscal year 2008 through fiscal year 2024.

The Q&A-style report, GAO-26-107779, was prepared at the initiative of the Comptroller General in consultation with congressional committees and addressed to the leaders of the Senate health committee, among others. GAO said it wanted to give Congress context for changes at the agency after a March 2025 Department of Health and Human Services fact sheet said the FDA's workforce would be reduced by about 3,500 full-time equivalent staff. Details on how far those changes had reshaped the agency's structure and workforce had not been publicly released as of December 2025, GAO said.

Funding shifts toward industry fees

FDA funding grew over the 17-year period, "largely from user fees," the report said. The agency moved from being funded mostly through discretionary appropriations to being funded in nearly equal amounts by user fees, which are paid by the manufacturers it regulates, and budget authority. Growth in user fees outpaced growth in appropriations for human drugs, medical devices and biologics, GAO found.

The fees come with limits. While prescription drug user fees can be spent on monitoring the safety of drugs already on the market, the legislation authorizing medical device user fees "does not explicitly allow their use for post-market safety activities," GAO wrote, though it permits a narrower set of monitoring work such as evaluating postmarket studies required as a condition of approval.

Staffing also rose, from 9,818 full-time equivalents in fiscal 2008 to 19,744 in fiscal 2024, according to the report. Over the same years Congress widened the agency's remit, including tobacco regulation in 2009, a new category of over-the-counter hearing aids under a 2017 law, and expanded authority over device cybersecurity in 2023. GAO said the FDA formally set up a Division of Medical Device Cybersecurity in 2024, according to agency officials.

Inspectors hard to keep and slow to train

Drawing on reports issued from January 2020 through January 2025, GAO said investigator attrition, driven by low pay and frequent travel among other issues, reduced the number of clinical research and drug manufacturing inspections the FDA could carry out compared with earlier years. FDA officials told GAO it can take two to three years to fully train a new clinical research investigator and about two years for a food investigator.

In a blog post accompanying the report, GAO said the vacancy rate among drug inspectors rose from 9% to 16% between November 2021 and June 2024 and that the FDA "has been able to conduct fewer inspections in recent years."

The report also said FDA officials told GAO in early 2025 that the agency's January 2024 Strategic Workforce Plan was no longer current. In August 2025, officials said work was under way to align the agency's workforce approach with the administration's priorities and available resources.

GAO said it had previously made recommendations to address these problems and that the FDA agreed with them. The FDA was taking steps in response, but as of December 2025 it had not fully implemented most of them, according to the report. The FDA reviewed a draft and provided technical comments, GAO said.

The blog post also pointed to a separate GAO report released in December on the FDA's oversight of medical device recalls. That report found the agency oversaw 3,934 device recalls from fiscal 2020 to 2024 and that, according to officials, insufficient staff limited its ability to conduct oversight activities.