What percentage of the FDA's budget comes from pharmaceutical companies in 2025?

Checked on November 29, 2025
Disclaimer: Factually can make mistakes. Please verify important information or breaking news. Learn more.

Executive summary

The FDA’s total FY2025 program level is $7.2 billion, of which user fees — payments from regulated industries including pharmaceutical companies — total $3.5 billion, meaning user fees make up roughly 49% of the FY2025 program level [1] [2]. Sources describe user fees as payments “by the regulated industry (e.g., drug manufacturers)” and note that user fees historically comprise a large and growing share of FDA funding [3] [4].

1. How the math is commonly presented — nearly half the budget

Reporting and FDA budget documents show FY2025 program funding at $7.2 billion and list $3.5 billion in existing user fees; simple division — $3.5B ÷ $7.2B — yields about 49% of the program level coming from user fees [1] [2]. Multiple outlets and watchdog groups have long summarized FDA funding this way to highlight the scale of industry payments to the agency [3] [5].

2. Who pays those user fees — not only “big pharma” but many regulated actors

The phrase “user fees” covers fees paid by various regulated industries, including drug and biologic manufacturers, generic and biosimilar sponsors, medical device makers, and other product makers. Budget documents and policy analyses frame these fees as collected from “the regulated industry (e.g., drug manufacturers)” rather than solely large pharmaceutical corporations [3] [6]. Available sources do not list a precise breakdown of the $3.5 billion by company type in FY2025.

3. Why these fees exist — speed and resources, by design

User fees were created to fund the staff and activities needed to review products and conduct inspections more quickly; the FY2025 materials explicitly link user fees to resourcing review and oversight functions [2] [1]. Policy briefs trace the origin of this model to the early 1990s and show that, over decades, user fees have grown to be a substantial portion of FDA funding [4] [6].

4. Limits of the simple percentage — “program level” vs. appropriations

Congressional and FDA documents stress that “total program level” mixes two funding streams: annual appropriations (taxpayer-funded budget authority) and user fees. The program level figure is the amount FDA can spend; it is not identical to line-item appropriations alone [3]. Therefore, saying “X% of the FDA budget comes from pharmaceutical companies” simplifies a more complex accounting structure that groups diverse user fees and appropriations into one program total [3] [4].

5. Disagreements and political context — contested framing

Advocates and critics disagree over what the percentage signifies. Critics argue that when nearly half the FDA’s program funding derives from industry user fees, regulated companies gain leverage over priorities and timelines; proponents emphasize that user fees are intended to supplement not replace taxpayer funding and to speed reviews [7] [4]. Congressional budget fights over FY2025 and FY2026 make user-fee levels a live political issue, with appropriations and user fees negotiated separately [8] [9].

6. What the sources explicitly say — careful wording

The FDA’s FY2025 materials list $3.5 billion from existing user fees within a $7.2 billion program level [1]. Reuters reported the same FY2025 totals and explained that user fees are “payments made by pharmaceutical and medical device manufacturers to fund the staff resources needed to review their products quickly” [2]. Congressional Research Service and HHS analyses reiterate that the program level combines appropriations and user fees [3] [4].

7. What I cannot verify from these documents

Available sources do not provide a precise FY2025 breakdown isolating only “pharmaceutical companies” (as opposed to all user-fee payers), nor do they report a definitive percentage of FDA funding coming exclusively from pharmaceutical firms versus device or other industries; the $3.5 billion figure groups multiple user-fee categories [1] [6]. Available sources do not mention any alternate calculations that subtract certain user-fee categories to produce a different percentage for “pharmaceuticals only” [1] [2].

8. Bottom line for readers

Using the FY2025 program totals in the FDA documents and media reporting, about 49% of the FDA’s program-level funding comes from user fees — the payments that industry (including drugmakers and device firms) makes to fund product review and related activities [1] [2]. That headline number reflects how funding is counted in federal budget documents; it does not, by itself, resolve policy debates about influence, safeguards, or whether user fees should be increased or reduced [3] [7].

Want to dive deeper?
How much of the FDA's prescription drug review budget is industry-funded in 2025?
What user-fee programs do pharmaceutical companies pay to the FDA and how have they changed since 2012?
How does industry funding affect FDA approval times and decisions in 2025?
What reforms have been proposed or passed in 2023–2025 to reduce FDA dependence on drug company fees?
Which other federal health agencies receive industry funding and how do their shares compare to the FDA?