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# FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO
- URL: https://www.fdaweb.com/fdas-expanding-role-staff-cuts-challenge-oversight-gao/
- Published: 2026-02-03T12:00:00.000Z
- Updated: 2026-09-14T15:32:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160590

FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, even as the agency now faces workforce reductions and organizational restructuring that could further strain its oversight capacity, according to a new report from the Government Accountability Office. The just-released [GAO report](https://www.gao.gov/products/gao-26-107779?utm%5Fcampaign=usgao%5Femail&utm%5Fcontent=topic%5Fhealth&utm%5Fmedium=email&utm%5Fsource=govdelivery) examines how FDA’s authority, funding, and staffing evolved over a 17-year period and assesses whether the agency is positioned to meet its growing regulatory obligations. The review was initiated by the Comptroller General in consultation with congressional committees to provide lawmakers with context as HHS undertakes government-wide downsizing and reorganization.

FDA regulates over $3.9 trillion in economic activity annually, GAO notes, and overseeing the medical products, food, and tobacco portfolio has become increasingly complex due to advances in underlying science and the globalization of manufacturing and supply chains.

Concerns about FDA’s oversight capacity are longstanding, GAO says. The government watchdog added the agency’s medical product oversight to its High-Risk List in 2009 and food safety oversight in 2007, citing persistent challenges that could impair the agency’s ability to protect public health. FDA oversight issues also contribute to two additional high-risk areas: HHS’s leadership and coordination of public health emergencies, and skills gaps across the federal workforce, it says

Against this backdrop, GAO notes that Congress repeatedly expanded FDA’s authority over the past two decades. Major additions included regulation of tobacco products under the 2009 Tobacco Control Act, oversight of biosimilars through the Affordable Care Act, expanded food safety authority under the Food Safety Modernization Act, creation of an over-the-counter hearing aid category in 2017, strengthened cosmetics oversight in 2022, and new authority in 2023 to impose cybersecurity requirements on medical devices.

During the same period, FDA’s funding and staffing roughly doubled. Total funding growth was driven largely by expanded industry user fee programs, GAO says. In fiscal year 2008, FDA relied primarily on congressional appropriations; by fiscal year 2024, its budget was funded almost evenly by appropriations and user fees. Prescription drug user fees alone grew from about $459 million in 2008 to roughly $1.4 billion in 2024.

GAO reports that staffing increased from approximately 9,800 full-time equivalents in 2008 to nearly 19,800 in 2024\. However, many of those gains were tied to user fee-funded medical product programs, while inspection-intensive areas such as food safety continued to face resource constraints. GAO and the HHS Office of Inspector General have repeatedly cited investigator attrition, lengthy training timelines, and workforce instability as limiting FDA’s inspection and oversight capacity.

Those pressures may intensify, according to GAO. In 2025, government-wide directives required federal agencies to downsize and reorganize. A 3/2025 HHS fact sheet indicated that FDA’s workforce would be reduced by about 3,500 full-time equivalent staff. FDA commissioner **Marty Makary**’s testimony in 5/2025 outlined plans to centralize and streamline shared functions that had previously been duplicated across the agency, but GAO says details on the final structure and workforce impact had not been publicly released as of 12/2025.

GAO emphasizes that its review focuses on challenges identified prior to the proposed staff reductions, suggesting that unresolved issues — such as recruitment and retention difficulties, fragmented IT systems, and delays in implementing prior GAO recommendations — could be exacerbated by further workforce cuts.

As of 12/2025, GAO says FDA had not fully implemented most of the previous key recommendations related to workforce planning, inspection capacity, and infrastructure modernization. GAO concludes that while FDA has taken steps to address some concerns, persistent staffing and management challenges continue to pose risks to the agency’s ability to meet its expanding oversight responsibilities amid ongoing organizational change.