H.R. 4273: Over-the-Counter Monograph Drug User Fee Amendments

This bill, known as the Over-the-Counter Monograph Drug User Fee Amendments, aims to revise and extend the user fee program for over-the-counter (OTC) monograph drugs as outlined in the Federal Food, Drug, and Cosmetic Act. The main features of the bill include the following:

1. Purpose of the Act

The act establishes a framework for collecting fees related to the regulation of OTC monograph drugs to support their review and oversight.

2. User Fees

The act allows the assessment and collection of fees from entities that manufacture OTC monograph drugs. These fees will be used to fund activities related to the regulation and evaluation of these drugs.

3. Fee Structure

• The bill specifies how and when the fees will be assessed for the next few fiscal years, including specific due dates and amounts for each fiscal year.
• It defines the revenue amounts that need to be generated through these fees to cover the regulatory costs associated with OTC monograph drugs.
• Additional adjustments are made to ensure that the fees reflect inflation and operating costs over time.

4. Fee Revenue Amounts

For fiscal years 2026 through 2030, the total facility fee revenue amounts will include the base revenue along with inflation adjustments and specific amounts set for each fiscal year, such as:

• $2,373,000 for fiscal year 2026
• $1,233,000 for fiscal year 2027
• $854,000 for fiscal year 2028

5. Adjustments and Annual Fee Setting

The Secretary of Health and Human Services is tasked with establishing the facility fees and publishing them annually. It includes provisions for adjusting fees based on previous years’ revenue and specific factors like inflation.

6. Reporting and Reauthorization

The bill includes requirements for reporting the results and progress of the user fee program and mandates reauthorization processes for it. The provisions of the act will be effective until October 1, 2030.

7. Effective Date

The amendments proposed in this act will take effect on October 1, 2025. However, the user fees will start to be assessed from that date regardless of the enactment of the bill.

8. Savings and Sunset Clauses

Previous regulations will continue to be effective for fee assessment for fiscal years prior to 2026, ensuring a transition from the old fee structure to the new one outlined in this bill.

Relevant Companies

• PG - Procter & Gamble: The company produces various OTC medications and health products, which may be subject to the user fees established by this bill.
• CLX - The Clorox Company: Similar to Procter & Gamble, Clorox manufactures OTC products that could be impacted by the regulation and fees under this bill.
• MDLZ - Mondelez International: While predominantly known for snacks, the company may also be involved in OTC health products that could be affected by new fees and regulations.