Sponsors (4)
Want my take on what this bill would do?
This is not an official government website.
Copyright © 2026 PLEJ LC. All rights reserved.
This bill keeps the federal program that funds work on nonprescription (over‑the‑counter) medicines going for five more years and updates how companies are charged. It extends the program through 2030, sets when fees are due, and explains how yearly fee targets are calculated. The money is dedicated to activities for these drugs.
Companies that own facilities making these medicines will pay facility fees on a set schedule, with special timing in 2026 and 2027, and a regular fall due date starting in 2028. Firms that fully stop all related activities before certain cutoff dates won’t owe the fee for that year. The law also allows a one‑time fee increase later in the program if the number of facilities grows more than expected.
Who is affected
What changes
When
Referred to the House Committee on Energy and Commerce.
Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (codified at this citation) shall cease to be effective on October 1, 2030.
Section 744N of the Federal Food, Drug, and Cosmetic Act (codified at this citation) shall cease to be effective on January 31, 2031.
Amends section 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72) to modify fee assessment periods and due dates, specify fee revenue calculation for fiscal years 2026–2030 including specified dollar amounts for certain years, revise adjustment calculations and amounts for fiscal years 2026–2030, add a one-time facility fee workload adjustment for FY2028–2030 (with conditions), require annual fee setting and publication at least 60 days before each fiscal year, and update the crediting/availability period to 2026–2030.
Amends section 744L(9)(A) of the FD&C Act by (1) altering punctuation in clause (v), (2) making minor wording edits in clause (vi), and (3) adding a new clause (vii) that defines the addition or modification of a testing procedure for OTC monograph drugs when the procedure reflects a voluntary consensus standard established by a national or international standards development organization and recognized by the Secretary through a process described in guidance initially published in July 2023 or any successor guidance publicly available on the agency website.
Amends subsection (h) to expand who may receive development advice to include organizations nominated by sponsors or requestors to represent their interests in a proceeding.
Amends section 744L(9)(A) by (1) modifying clause (v) punctuation, (2) changing wording and punctuation in clause (vi), and (3) adding a new clause (vii) that covers addition or modification of testing procedures for OTC monograph drugs when those procedures reflect voluntary consensus standards established by a national or international standards development organization and recognized by the Secretary through specified FDA guidance.
Introduced July 2, 2025 by Robert E. Latta · Last progress July 2, 2025
Placed on the Union Calendar, Calendar No. 254.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Committee Consideration and Mark-up Session Held
