Us Congress House Bill HB4273

Us Congress 2025-2026 Regular Session

• Introduced: 7/2/25
• Refer: 7/2/25
• Report Pass: 7/23/25

Caption

Over-the-Counter Monograph Drug User Fee Amendments

Impact

The enactment of HB 4273 is expected to have significant implications for state laws governing pharmaceutical sales and distribution. By implementing a structured fee system for manufacturers and importers of OTC drugs, this bill will facilitate more rigorous oversight of these products, aiming to improve public health outcomes. Importantly, the legislation is designed to ensure that OTC drugs remain accessible while maintaining safety standards, thus balancing regulation and market accessibility for consumers.

Summary

House Bill 4273, known as the Over-the-Counter Monograph Drug User Fee Amendments, seeks to amend the Federal Food, Drug, and Cosmetic Act to enhance and extend the fee program applicable to over-the-counter (OTC) monograph drugs. Introduced on July 2, 2025, the bill aims to allow the Food and Drug Administration (FDA) to collect user fees to support the review and approval processes for OTC drugs, ensuring they meet safety and efficacy standards. This legislative effort recognizes the growing importance of OTC medications in the market and aims to provide a more sustainable funding model for their regulation.

Contention

However, the proposed changes have sparked discussions among stakeholders. Proponents argue that the fees will provide the FDA with necessary resources to effectively oversee an ever-expanding market of OTC products, which can sometimes lack comprehensive regulatory scrutiny. Critics may express concerns over the potential financial burden these fees may impose on smaller manufacturers, possibly affecting market competition. Furthermore, there may be debates regarding how effectively these funds will be allocated and monitored to ensure they directly benefit public health initiatives related to OTC drugs.