Us Congress Senate Bill SB2292

Us Congress 2025-2026 Regular Session

• Introduced: 7/15/25
• Refer: 7/15/25

Caption

Over-the-Counter Monograph Drug User Fee Amendments

Impact

If enacted, SB2292 will have significant implications on the state laws governing drug safety and approval processes. The introduction of user fees is intended to provide the FDA with necessary resources for effective regulation of OTC monograph drugs, which could lead to faster approvals and better oversight of product quality. Additionally, the bill outlines a schedule for fee adjustments over the years and provides a mechanism for the assessment of additional costs to adapt to market changes, reflecting an evolving approach to drug regulation in the ongoing context of public health and safety.

Summary

SB2292, titled the Over-the-Counter Monograph Drug User Fee Amendments, seeks to amend the Federal Food, Drug, and Cosmetic Act by revising and extending the user fee program specifically for over-the-counter (OTC) monograph drugs. The bill aims to ensure that the fees collected will be used to support activities related to OTC monograph drugs by establishing a system that allows the Food and Drug Administration (FDA) to assess these fees annually. The proposed changes will help streamline the regulatory processes surrounding OTC drugs, making them more efficient and responsive to market needs.

Contention

Notably, the bill includes provisions that some stakeholders may view as contentious. Concerns may arise over the sustainability and fairness of implementing user fees, particularly how they may impact smaller drug manufacturers compared to larger companies. Critics could argue that such fees may create barriers to entry in the OTC drug market, potentially leading to less competition and higher prices for consumers. Additionally, ensuring that the fees collected are indeed allocated efficiently and effectively toward enhancing the FDA's regulatory capabilities for OTC drugs might be a point of scrutiny and ongoing debate.