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Amends Section 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72) to: revise the applicable assessment periods for fee assessment for FY2026, FY2027, and FY2028 and subsequent years; set due dates for facility fees for FY2026, require two-installment payments for FY2027, and set due dates for FY2028 and subsequent years; specify total facility fee revenue components and specified additional dollar amounts for FY2026–FY2028 and direct cost adjustment amounts for FY2026–FY2030; add a one-time facility fee workload adjustment for FY2028–FY2030 with conditions and calculation; require the Secretary to establish and publish fees not later than 60 days before the first day of each fiscal year; and update the crediting/availability period in subsection (f) from 2021–2025 to 2026–2030.
Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act shall cease to be effective on October 1, 2030.
Section 744N of the Federal Food, Drug, and Cosmetic Act shall cease to be effective on January 31, 2031.
Modifies clauses (v) and (vi) for punctuation/wording and adds a new clause (vii) that allows addition or modification of testing procedures for OTC monograph drugs when the testing reflects a voluntary consensus standard established by a national or international standards development organization and recognized by the Secretary through FDA 'guidance for industry' (initially published July 2023) available on the FDA website.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced July 15, 2025 by James E. Banks · Last progress July 15, 2025
Creates a renewed and revised user-fee framework for over-the-counter (OTC) monograph drugs: it narrows fee revenues to OTC monograph activities, updates definitions and allowable testing standards, sets new fee formulas and annual scheduling for fiscal years 2026–2030, and requires the Secretary to publish fees on a fixed timetable. The Act also updates reporting language, preserves old fee rules for pre‑2026 fiscal years, and establishes sunset dates for the new authorities in late 2030/early 2031. Manufacturers, labelers, pharmacies/wholesalers, and the FDA are the main parties affected: industry will face revised fee amounts and timing rules, the FDA will receive user-fee funding limited to OTC monograph program work, and some regulatory flexibility is added by recognizing voluntary consensus testing standards via FDA guidance. The amendments take effect Oct. 1, 2025 (or upon enactment if later), with fees assessed beginning Oct. 1, 2025 regardless of enactment timing.
Congress finds that the fees authorized by the amendments made in this Act will be dedicated to OTC monograph drug activities.
The OTC monograph drug activities to be funded are the activities set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.).
The goals referenced are those set forth in letters from the Secretary of Health and Human Services to the Chairman of the House Committee on Energy and Commerce and to the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, as recorded in the Congressional Record.
Amend clause (v) of Section 744L(9)(A) by replacing the clause’s ending punctuation with a semicolon.
Amend clause (vi) of Section 744L(9)(A) by (A) changing the word “addition” to “the addition” and (B) replacing the clause’s ending period with a semicolon.
Who is affected and how:
Drug manufacturers and applicants: Directly affected as primary fee payers; they must budget for revised annual fees and comply with the updated assessment timeline. Changes to allowed testing procedures (recognizing voluntary consensus standards via FDA guidance) may reduce testing burden for some firms if adopted.
Pharmacies and wholesalers / dispensers: May be assessed fees depending on the statutory fee categories and could face small increases in operating costs that may, over time, affect distribution or retail pricing dynamics.
Consumers: Indirectly affected because fee-funded FDA activities fund rulemaking, review, and oversight of OTC monograph products; adequacy of funding can affect review speed, safety oversight, and availability of OTC products.
FDA and HHS: Receive a dedicated revenue stream restricted to OTC monograph activities, enabling planning for program work but with clear limits on fund use, new reporting/timetable obligations, and responsibility to recognize specified consensus testing standards when appropriate.
Small businesses and startups in the OTC market: May feel proportionally larger impact from fees; the Act does not appear to include explicit small-business fee waivers in the text summarized, so affected entities should plan accordingly.
Timeline and administrative impact: The fixed annual fee publication timetable and updated crediting/availability rules create predictable requirements for agency rulemaking and industry compliance. Sunset dates mean the program is temporary unless extended by future legislation.
Overall effect: The law refines and extends fee-raising authority to resource FDA's OTC monograph work with clearer limits on fund use, updated technical recognition of testing standards, and new schedules and formulas for fees — while preserving prior rules for pre-2026 fees and setting explicit sunset dates for the new authority.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.