S. 2292: Over-the-Counter Monograph Drug User Fee Amendments

This bill, titled the Over-the-Counter Monograph Drug User Fee Amendments, seeks to revise and extend the user fee program for over-the-counter (OTC) monograph drugs as part of the Federal Food, Drug, and Cosmetic Act. Here’s a breakdown of what the bill would do:

1. Purpose and Findings

The bill aims to establish fees that will be allocated to activities related to the regulation of OTC monograph drugs. This includes ensuring drug safety and efficacy as outlined in previous legislation. Congress believes these fees will help fund necessary activities to maintain the integrity of OTC drug standards.

2. Definitions

The legislation sets forth new definitions and clarifications related to OTC monograph drugs, including procedures for testing and compliance with recognized standards by the Secretary of Health and Human Services (HHS).

3. Fee Structure

The bill details a system for assessing and using fees from manufacturers and facilities involved in the production of OTC monograph drugs. Key points include:

• The fees will be adjusted annually based on inflation and operational costs.
• Different fiscal years will have specific periods for fee assessments, including changes in revenue between 2026 and 2030.
• For example, the total fee revenue will increase for the fiscal years 2026 through 2030 with specific amounts outlined for each year.

4. Facility Fees

New provisions will be established regarding facility fees for drug manufacturers, including:

• The due dates for fees will vary based on fiscal year timelines.
• There will be increments of fee payments for certain fiscal years, ensuring that manufacturers are able to comply without undue burden.

5. Adjustments for Fees

Annual fee settings will take into account adjustments necessary to reflect the operational needs as well as any additional costs that may arise. The Secretary of HHS will be responsible for determining and publishing these fee amounts before the start of each fiscal year.

6. Reporting Requirements

The bill amends reporting requirements to ensure ongoing assessment of the fee program's effectiveness and may require adjustments based on industry responses. Reports will need to be provided within a stipulated time frame after each fiscal year.

7. Sunset Provision

The authorization for these provisions will expire on October 1, 2030, after which the program will be reassessed for its continuation.

8. Effective Date

The amendments proposed in this bill will take effect on October 1, 2025, ensuring that the new fee structures are in place for the upcoming fiscal years without delay.

Relevant Companies

• PFE (Pfizer Inc.): With a large range of OTC drugs, any changes in user fees may affect its pricing strategies and financial planning.
• PG (Procter & Gamble Co.): As a major manufacturer of OTC personal care and health products, changes in regulatory fees could impact cost structures.
• CLX (The Clorox Company): Involved in the manufacturing of OTC products, which may be subject to new fees under this legislation.