Over-the-Counter Monograph Drug User Fee Amendments

Bill Number: H.R. 4273
Origin Chamber: House
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-09-17: Placed on the Union Calendar, Calendar No. 254.
Last Updated: 2026-06-16T13:57:23Z

AI-Generated Summary

Purpose of the Legislation

This bill, titled the "Over-the-Counter Monograph Drug User Fee Amendments," amends the Federal Food, Drug, and Cosmetic Act to revise and extend a user fee program for over-the-counter (OTC) monograph drugs. OTC monograph drugs are non-prescription medications, such as pain relievers or sunscreens, that meet pre-established federal standards (called monographs) for safety, effectiveness, and labeling, without requiring individual approval from the Food and Drug Administration (FDA). The program's goal is to fund FDA activities related to developing, updating, and enforcing these standards through fees paid by industry, ensuring efficient regulation of these widely used products.

Key Provisions

Short Title and Findings: Names the Act and states that collected fees will support specific FDA goals for OTC drug activities, as outlined in prior letters from the Secretary of Health and Human Services to congressional committees.
Definitions: Expands the definition of an "OTC monograph order request" (a formal industry submission to change monograph standards) to include additions or modifications to testing procedures for OTC drugs, but only if these reflect voluntary consensus standards (widely accepted industry guidelines) from recognized national or international organizations, as detailed in FDA guidance.
Authority to Assess and Use Fees:
Establishes facility fees on OTC drug manufacturing sites, with adjusted assessment periods (e.g., 12 months ending December 31, 2025, for fiscal year 2026).
Sets due dates for fees, including installments for fiscal year 2027 and ties them to the enactment of annual appropriations laws.
Exempts facilities that stop OTC activities before specified dates.
Fee Revenue Amounts: Targets total revenue for fiscal years 2026–2030, including:
An annual base amount (starting from fiscal year 2025 levels).
Inflation adjustments.
Operating reserve adjustments (limited to 10 weeks of FDA operations).
Additional direct costs (e.g., $2.373 million in 2026, decreasing over time).
A one-time workload adjustment in 2028–2030 if the number of fee-paying facilities averages over 1,625 in the prior three years and arrears (unpaid fees) are below 30%.
Adjustments and Annual Fee Setting: Updates inflation calculations using the Consumer Price Index for the Washington-Arlington-Alexandria area; requires the FDA to publish fees in the Federal Register 60 days before each fiscal year starts.
Crediting and Availability of Fees: Fees collected are credited to the FDA and available until spent, extending coverage through fiscal year 2030.
Reauthorization and Reporting Requirements: Extends annual FDA performance reports on OTC activities through fiscal year 2030; requires reports on fee usage and goals.
Regulation of Certain Nonprescription Drugs: Allows FDA to provide development advice to sponsors, requestors, or their nominated representatives; includes a minor technical fix to related language.
Sunset Dates: The fee authority ends October 1, 2030; reporting ends January 31, 2031.
Effective Date and Savings Clause: Takes effect October 1, 2025, or upon enactment (whichever is later), with fees starting October 1, 2025; prior-year fees under the old law remain unaffected.

Significant Changes to Existing Law

Extension: Reauthorizes the program for five more years (2026–2030), preventing its expiration after 2025.
Fee Structure Revisions: Shifts assessment periods and due dates for facility fees to align with the federal fiscal year (October–September); introduces installment payments for 2027 and specific additional revenue targets (e.g., $854,000 in 2028).
Adjustment Mechanisms: Simplifies inflation adjustments to apply annually from 2026; caps operating reserves at 10 weeks (down from variable prior limits); adds fixed direct cost amounts that taper off by 2030; introduces a new one-time adjustment for facility growth.
Expanded Scope: Broadens what qualifies as an order request to include consensus-based testing changes, potentially streamlining industry submissions.
Reporting: Makes annual reports ongoing without a start-year reference and extends the deadline to 2030.

Potential Impacts

Government Agencies: Provides the FDA with dedicated, predictable funding (via industry fees) to review OTC drug standards, reducing reliance on general appropriations and enabling faster updates to monographs. This could improve efficiency in handling submissions but requires annual appropriations to activate fee collection.
Citizens: Enhances safety and availability of OTC drugs by supporting FDA oversight, potentially leading to quicker innovations in non-prescription products like allergy remedies or antiseptics, benefiting public health without increasing taxpayer costs.
International Relations: No direct impacts; the bill focuses on domestic FDA operations and U.S.-based facilities, though consensus standards may indirectly align with global pharmaceutical norms.

Main Stakeholders Affected

FDA: Primary beneficiary, gaining resources for OTC drug regulation.
OTC Drug Manufacturers and Facilities: Required to pay facility fees (based on the number of sites), which could raise costs but offer benefits like faster regulatory processes.
Consumers and Healthcare Providers: Indirectly affected through improved access to safe, effective OTC products.
Industry Associations: Involved in nominating representatives for FDA advice and developing consensus standards.

Notable Legal, Constitutional, or Political Implications

Legal: Reinforces the user fee model (where industry pays for specific FDA services), which is authorized under the Federal Food, Drug, and Cosmetic Act; the savings clause ensures continuity, avoiding disruptions in fee collection. The emphasis on voluntary consensus standards promotes consistency without mandating new regulations.
Constitutional: Aligns with Congress's power to regulate commerce and appropriate funds, as fees are tied to appropriations acts, preventing unauthorized spending.
Political: Bipartisan sponsorship (e.g., by Reps. Latta, DeGette, Crenshaw, and Dingell) reflects routine reauthorization of FDA user fee programs, fostering industry-FDA collaboration; no major controversies noted, but fee increases could spark debate over industry burdens.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Latta, Robert E. [R-OH-5]

Cosponsors (3)

Rep. DeGette, Diana [D-CO-1], Rep. Crenshaw, Dan [R-TX-2], Rep. Dingell, Debbie [D-MI-6]

Recent Actions

2025-09-17: Placed on the Union Calendar, Calendar No. 254.
2025-09-17: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
2025-09-17: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
2025-07-23: Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
2025-07-23: Committee Consideration and Mark-up Session Held
2025-07-02: Referred to the House Committee on Energy and Commerce.
2025-07-02: Introduced in House
2025-07-02: Introduced in House

Bill Versions

Over-the-Counter Monograph Drug User Fee Amendments — issued 2025-07-02 — PDF (16 pages)
Over-the-Counter Monograph Drug User Fee Amendments — issued 2025-09-17 — PDF (20 pages)