FDA presents five-year financial plans for PDUFA, BaSUFA and GDUFA

The U.S. Food and Drug Administration on Tuesday presented five-year financial plans for its human drug user-fee programs, reporting projected fiscal year 2026 totals and carryover balances for each program.

Joshua Kirk, a financial management specialist in FDA’s Office of Finance, Budget, and Acquisition, said the agency provided actuals for fiscal years 2023–2025 and planned estimates for fiscal years 2026–2027. He said planned estimates include total budgetary resources (user-fee funds plus carryover), estimated collections and recoveries, and total obligations. "For each user fee program, we have provided actuals for fiscal year 23, 24, and 25," Kirk said, describing the presentation’s assumptions and definitions.

Kirk reported that PDUFA 7 is projected for FY26 to have about $1.99 billion in total budgetary resources, which include roughly $414 million in carryover, about $1.56 billion in estimated collections and $17.5 million in recoveries; estimated obligations for FY26 were shown at about $1.39 billion, leaving a projected net carryover of approximately $496 million. He cautioned that operating-reserve adjustments could alter future carryover figures if collections or obligations change.

On BaSUFA 3, Kirk reported FY26 projections of approximately $86 million in total budgetary resources, including $29 million in carryover, about $56 million in estimated collections, and $1.3 million in recoveries; estimated obligations were shown around $52 million with a projected net carryover of about $33 million.

For GDUFA 3, Kirk reported FY26 projections of roughly $821 million in total budgetary resources, including $140.5 million in carryover, about $671 million in estimated collections and $9.6 million in recoveries; estimated obligations were shown at about $611.6 million and a projected net carryover of about $203.8 million. He repeated that any operating-reserve adjustment made during FY27 fee setting could affect FY27 projections.

Benjamin Mons, FDA’s chief financial officer, framed the meeting as part of the agency’s commitment under the 2022 FDA user-fee reauthorization. "This annual meeting is part of FDA's commitment under PDUFA 7, BaSUFA 3, and GDUFA 3 to enhance transparency and the financial management of user fee resources," Mons said.

The FDA noted that user-fee collections are used alongside non-user-fee appropriations to hire and support staff who review human drug submissions and that, in practice, net collections can differ from target revenue if the number of fee-paying units varies from estimates made when fees are set.

The public docket for submitting comments on the meeting is FDA-2026-N-3273 and will remain open until July 23, 2026, at 11:59 p.m. Eastern; meeting materials, slides, recordings and a transcript will be posted on FDA.gov following the meeting.

No formal votes or policy changes were taken at the session; the meeting provided an informational update and a timeline for public comment.