User fees are now more than half of the FDA budget, and 73 percent of its drug review program
The FDA's FY2026 operating plan totals $7.06 billion: $3.43 billion appropriated by Congress and $3.63 billion in user fees paid by the industries it regulates. The Human Drugs program is $2.50 billion, of which $1.81 billion is fees.
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: An operating plan is a spending plan, not an audited outturn, and the plan itself notes it will use carryover balances consistent with the fee agreements. The fee-act sums across programs are ours, not a line the plan prints. Funded by is not controlled by: the plan states amounts, and no inference about review decisions is drawn from it here.
Significant findings
The FDA publishes an operating plan that lists every program and, under each, how much is budget authority (money Congress appropriates) and how much is user fees (money paid by the regulated industries under laws Congress reauthorizes every five years). The FY2026 plan, dollars in millions, gives a total program level of 7,055.869, made up of 3,425.650 in discretionary budget authority and 3,630.219 in user fees. Fees are 51 percent of the agency. In the plan's FY2025 final column the same lines are 3,575.650 appropriated and 3,440.024 in fees, so FY2026 is the first year fees exceeded appropriations.
By program, FY2026: Human Drugs 2,497.984 (684.841 appropriated, 1,813.143 fees, 73 percent); Biologics 601.291 (259.295 and 341.996, 57 percent); Devices and Radiological Health 913.719 (454.874 and 458.845, 50 percent); Human Foods 1,184.725 (1,171.319 and 13.406, 1 percent); Animal Drugs and Feeds 279.317 (218.399 and 60.918); Center for Tobacco Products 688.038 (0 appropriated, 688.038 fees, 100 percent); National Center for Toxicological Research 71.758, all appropriated.
The plan lists each fee act under every program it funds. Adding the lines paid by drug makers is our arithmetic on the plan's figures: the Prescription Drug User Fee Act across the human drugs and biologics centers, their field operations, agency-wide activities and rent comes to about 1,556; the Generic Drug User Fee Act about 671; the Biosimilars User Fee Act about 56; over-the-counter monograph fees about 38; priority review vouchers about 13. Together about 2,333, which is 33 percent of the whole agency and 64 percent of all user fees. Tobacco fees are about 712, device fees about 478, animal drug fees about 63.
Worth asking
The center that decides whether a psychiatric drug reaches the market is paid about two dollars and sixty cents by applicants for every dollar of tax money. The fees are paid whether an application is approved or refused, and nothing in the plan shows a fee changing a decision. What the plan shows is the amount and the direction of the money, and that the food side of the agency, by contrast, is almost entirely tax funded.
Source
Food and Drug Administration Operating Plan for FY 2026 (Dollars in Millions) — US Food and Drug Administration (2025)
How this was scored
- Study design
- not recorded
- Funding
- not recorded
- Published in
- not recorded
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
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Published September 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: An operating plan is a spending plan, not an audited outturn, and the plan itself notes it will use carryover balances consistent with the fee agreements. The fee-act sums across programs are ours, not a line the plan prints. Funded by is not controlled by: the plan states amounts, and no inference about review decisions is drawn from it here. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Food and Drug Administration Operating Plan for FY 2026 (Dollars in Millions) — US Food and Drug Administration (2025). The full source is linked on this page so you can read it yourself.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.