Over-the-Counter Monograph Drug User Fee Amendments
Over-the-Counter Drug Program: Funding and Rules Extension
This bill has been approved by the House committee and is now waiting for a vote by the full House of Representatives. It is currently moving forward as it has been placed on the official calendar for future consideration. There is no companion bill listed at this time.
Legislative Progress
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
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.
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.
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.
Committee Consideration and Mark-up Session Held
Referred to the House Committee on Energy and Commerce.
Votes
No votes have been recorded for this legislation yet.
News
No related news coverage found for this legislation yet.
Source Information
Document Type
Congressional Bill
Official Title
Over-the-Counter Monograph Drug User Fee Amendments
Data Sources
Sponsor
Cosponsors
(3)Analysis generated by AI. Always verify with official sources.