FDA's drug fees tripled. Its inspectors kept leaving.

Every time a drug company files an application, it pays the FDA a fee.▸ Those fees — set by law, negotiated with industry every five years — exist for a specific reason: to fund the reviewers who approve new drugs and the investigators who inspect the plants making them. The FDA now oversees products worth more than $3.9 trillion — about 21 cents of every dollar Americans spent in 2024. Congress and industry have let the fee revenue supporting that job climb for nearly two decades. The workforce that actually walks the factory floors has not kept pace.

Under the Prescription Drug User Fee Act (PDUFA), FDA sets a base revenue target each year for the fees it collects from drug manufacturers to fund application review and inspection work.▸ Per the U.S. Government Accountability Office's review of FDA's funding from fiscal years 2008 through 2024, that base revenue grew from about $459 million in FY2008 to about $1.4 billion in FY2024. The FY2026 rate, published by FDA in the Federal Register, sets the exact figure at $1,434,377,467 — confirming the fee has more or less plateaued at roughly triple its 2008 level.

Over the same 2008–2024 window, GAO found FDA's total staffing more than doubled — from 9,818 full-time-equivalent employees in FY2008 to 19,744 in FY2024, with most of that growth funded by user fees like PDUFA's. On paper, the agency responsible for drug safety got a great deal bigger and a great deal better funded.▸ The part of the job that can't be done from a desk didn't share in it.

FDA's roughly 230 U.S.-based general-pool investigators conduct the majority of both domestic and foreign drug manufacturing inspections — the visits that catch contamination, mislabeling, and the kind of manufacturing failures that have caused vision loss and death in patients.▸ GAO's November 2024 review of that workforce found the vacancy rate in this pool rose from 9% in November 2021 (20 open positions) to 16% in June 2024 (37 open positions) — investigators leaving faster than FDA, with all its added fee revenue, could replace them.

The consequence shows up directly in inspection counts.▸ FDA conducted 621 foreign and 444 domestic drug manufacturing inspections in fiscal year 2023 — 1,065 total, but 36% fewer than in fiscal year 2019, before the pandemic disrupted travel and staffing recovered only partway. GAO's recommendation — that FDA address the "root causes of investigator attrition," including travel burden, pay, and work-life balance — dates to that same report. HHS agreed with it. As of December 2025, GAO reported it still hadn't been implemented.

Meanwhile the workforce is about to get smaller on purpose.▸ A March 2025 HHS reorganization fact sheet, cited in GAO's February 2026 review, put FDA's planned staffing reduction at roughly 3,500 full-time-equivalent positions — details on which offices absorb the cut were still unreleased as of December 2025. The fee that pays for inspectors keeps growing. The agency's own plan is to have fewer people on the payroll to spend it on.

Fee and staffing figures span slightly different vintages — FY2008–FY2026 for PDUFA revenue, November 2021–June 2024 for investigator vacancies, fiscal years 2019–2023 for inspection counts — because those are the most recent periods each cited report covers.