who pays for the fda: the budget, the user fees, and the share that comes from drug companies

the agency that decides whether a psychiatric drug can be sold is paid, in part, by the companies that want to sell it. that sentence is true, and it is also incomplete. this page is the complete version: how much, from whom, spent on what, since when, and what the record says and does not say about what the money buys.

five sources, all of them government documents: the fda's own fy2026 operating plan, which lists every budget line and every fee act that funds it; the congressional research service's fact sheet, updated june 2026; the hhs planning office's 2023 brief on user fees; the commissioner's senate testimony on the fy2026 request; and the agency's budget index. every number below is one of theirs, or our addition of theirs, and says which.

two kinds of money

the fda runs on budget authority, the money congress appropriates each year, and user fees, which the industries it regulates pay under laws congress reauthorizes every five years. the hhs brief describes the split plainly: budget appropriations “are borne by the public more broadly through taxes, while user fees are directly supported by sponsors of medical product applications through reduced profit margins and indirectly borne by consumers to the extent that fees are passed through to consumers through increased prices”^[3].

in the fy2026 operating plan the totals are these, in millions of dollars^[1]:

fees are 51 percent of the agency. fy2026 is the first year that number passed fifty; the year before, the plan's fy2025 final column has $3,440 million in fees against $3,576 million appropriated^[1]. the crs series, which includes a small mandatory color-certification fee the operating plan leaves out, puts the fy2026 total at $7.069 billion and the fee share at 51.5 percent^[2].

what drug companies pay

not every fee comes from a drug company. tobacco manufacturers fund the tobacco center entirely, device makers fund half of theirs, and there are small animal-drug, food and export fees. the operating plan lists each fee act under every program it funds, so the drug industry's share can be added up^[1]. this addition is ours, in millions of dollars, fy2026:

drug, generic, biosimilar and otc makers together pay about $2.3 billion: a third of the whole agency and 64 percent of all user fees^[1]. pdufa alone, spread across the human drugs and biologics centers, their field staff, agency-wide activities and rent, is about $1.56 billion^[1]; the crs puts the fy2027 pdufa request at $1.64 billion, the largest single fee program, ahead of tobacco at $712 million and generics at $704 million^[2].

how it got this way

in fy1992 the fda's budget was “just under $1 billion” and all of it was appropriated^[3]. review of a new drug application then took 29 months on average, and the hhs brief records why the fees came: “In response, industry, with support from patient advocates, agreed to pay user fees beginning in 1992 to supplement the FDA budget in exchange for agreements to reduce review times”^[3]. the legal shape that made it permissible is in the same document: a “public health component” funded by appropriations and an “industry benefit” component funded by fees^[3]. devices followed in 2002, animal drugs in 2003, tobacco in 2009, generics and biosimilars in 2012, otc drugs in 2020^[2],[3].

the fee share has climbed almost every year since. the crs series, enacted totals unless marked^[2]:

the crs states the trend in one sentence: “Between FY2021 and FY2026, FDA's enacted annual total program level increased from $6.050 billion to $7.069 billion”, with fee revenue up more than 39 percent and appropriations up 7 percent^[2]. the fy2026 request itself asked for less tax money, not more: $6.8 billion in total, $3.2 billion appropriated and $3.6 billion in fees, an 11.5 percent cut to budget authority that the commissioner said would “enable the Agency to operate more efficiently, while addressing critical public health and safety priorities”^[4]. congress appropriated more than the request; the fees came in as forecast^[1],[4].

what the money can and cannot buy

the fees are not general revenue. the hhs brief: money from each fee program “has specific allowable and excluded costs in terms of what FDA is allowed to spend the funds on. Allowable costs are for activities that directly relate to the respective user fee program (e.g., application review, regulatory research to support the submission of high-quality applications and reduce time to approval, facility inspections, and post-market safety surveillance), while excluded costs are all FDA actions that are not specific to the user fee programs, such as agency infrastructure and other agency wide efforts”^[3]. each reauthorization comes with negotiated performance goals, “such as completing reviews within a specified timeframe”, and the current medical-product fee laws run to september 30, 2027^[3].

what the record supports is narrower and worth knowing on its own: the regulator's drug division is a fee-for-service operation whose customers are the applicants, whose service standards are review speed, and whose public funding has been shrinking as a share for thirty years^[1],[2],[3]. the money that funds a review is not the money that funds the drug's marketing afterwards; that is on how pharma makes and spends money, and the money that reaches doctors, nonprofits and newsrooms is the rest of the follow-the-money shelf.

what to ask

these are questions, not advice. they cost nothing.

• was this drug approved on the standard review clock or a priority one, and what did the approval letter say the evidence was?^[3]
• how long were the trials behind it, and how many people were in them? that is on how long psychiatric drugs were tested.
• what has the fda said about it since approval, and where is that written? the legal and safety records on this site are one place.