Congress·Reported·H.R. 4273

Over-the-Counter Monograph Drug User Fee Amendments

Over-the-Counter Drug Program: Funding and Rules Extension

Sep 17, 2025·View on Congress.gov·Read full text

Next up: The HouseNo action in 9 months

This bill is waiting for a vote by the full House of Representatives after being approved by a committee. Nothing has happened with this bill since September 2025, which means it has been stalled for about nine months. House leadership must decide to schedule a floor vote for the bill to move forward.

Legislative Progress

House

Senate

President

Law

Very likely to pass

This is a bipartisan bill that has already cleared the committee stage. These types of user fee renewals are standard and necessary for the FDA to continue its safety operations.

Key Points

This bill extends a program where companies that make over-the-counter drugs, like aspirin or cough syrup, pay fees to the government. These fees help the Food and Drug Administration (FDA) review the safety and quality of these medicines.
The plan keeps the program running through the year 2030. It sets specific budget targets for the next five years to make sure the FDA has enough money and staff to keep up with new drug reviews and safety checks.
It changes how the government calculates these fees by looking at inflation and how much work the agency is doing. If the number of drug-making factories grows significantly, the fees can be adjusted to cover the extra oversight needed.
The bill updates rules for testing drugs. It allows companies to use internationally recognized quality standards when testing their products, which helps ensure that medicines sold in stores are safe and work as they should.

Impact Analysis

Govbase has not yet run an impact analysis on this legislation.

Milestones

3 milestones6 actions

Sep 17, 2025House

Placed on the Union Calendar, Calendar No. 254.

The bill is now on the schedule for the full chamber to consider. It's in line for debate and a vote.

Sep 17, 2025House

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.

Jul 23, 2025House

Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.

The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.

Jul 23, 2025House

Committee Consideration and Mark-up Session Held

Jul 2, 2025House

Referred to the House Committee on Energy and Commerce.

No votes or news coverage recorded for this bill yet.

Source Information

Document Type

Congressional Bill

Official Title

Over-the-Counter Monograph Drug User Fee Amendments

Bill NumberHR 4273

Congress119th Congress

ChamberHouse of Representatives

Latest ActionPlaced on the Union Calendar, Calendar No. 254.

Data Sources

Congress.gov

Official legislative information

Read Full Bill Text

Sponsor

Cosponsors

(3)

D: 2R: 1

Analysis generated by AI. Always verify with official sources.