H.R. 4273 · 119th Congress

Over-the-Counter Monograph Drug User Fee Amendments

Introduced on Jul 2, 2025 by Robert E. Latta (R-OH-5). 3 cosponsors, 2 of them from another party. Latest action (Sep 17, 2025): Placed on the Union Calendar, Calendar No. 254.

Stage
Reported by committee
Introduced
Jul 2, 2025
Cosponsors
3
2 from the other party
Policy area
Health
Open in the Congress explorerCongress.govAlert me

Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes.

Subjects

  • Congressional oversight
  • Drug safety, medical device, and laboratory regulation
  • User charges and fees

Summary

By the Congressional Research Service (Introduced in House, Jul 2, 2025). Public domain.

Over-the-Counter Monograph Drug User Fee Amendments

This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.

Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.

The bill makes certain changes to OMUFA, including by

  • revising the total facility fee revenue amount to be collected for FY2026-FY2030,
  • revising due dates for facility fees,
  • permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, and
  • requiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.

Finally, the bill adds as a Tier 2 OTC monograph order request a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Robert E. LattaR-OH-5Sponsor

Democrats · 2

Republicans · 1

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Jul 2, 2025Introduced in House
  2. Jul 2, 2025Introduced in House
  3. Jul 2, 2025 · HouseReferred to the House Committee on Energy and Commerce.
  4. Jul 23, 2025 · HouseCommittee Consideration and Mark-up Session Held
  5. Jul 23, 2025 · HouseOrdered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
  6. Sep 17, 2025Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
  7. Sep 17, 2025 · HouseReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
  8. Sep 17, 2025 · HousePlaced on the Union Calendar, Calendar No. 254.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. CONSUMER HEALTHCARE PRODUCTS ASSOCIATION5 reports
    $1.1M reported (all issues)
  2. PERSONAL CARE PRODUCTS COUNCIL5 reports
    $360K reported (all issues)
  3. AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION4 reports
    $2.8M reported (all issues)
  4. HALEON US HOLDINGS LLC4 reports
    $430K reported (all issues)
  5. NATIONAL TREASURY EMPLOYEES UNION4 reports
    $1.3M reported (all issues)
  6. Chattem, Inc. DBA Opella3 reports
    $190K reported (all issues)
  7. THE PROCTER & GAMBLE COMPANY3 reports
    $2.6M reported (all issues)Federal contractor: THE PROCTER & GAMBLE DISTRIBUTING LLCAI match · 100%
  8. CHATTEM, INC D/B/A OPELLA1 report
    $160K reported (all issues)
  9. NATIONAL ASSOCIATION OF MANUFACTURERS1 report
    $1.9M reported (all issues)
  10. S.C. JOHNSON & SON, INC.1 report
    $79.4K reported (all issues)

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.