HR 4273: Over-the-Counter Monograph Drug User Fee Amendments

Overview

Bill Number: HR 4273

Title: Over-the-Counter Monograph Drug User Fee Amendments

Status: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.

Introduced: July 02, 2025

Purpose and Intent

The main purpose of HR 4273 is to establish a user fee program to support the Food and Drug Administration's (FDA) regulation and oversight of over-the-counter (OTC) monograph drugs. This legislation aims to provide the FDA with a stable source of funding to modernize the OTC drug review process, improve safety monitoring, and accelerate the development of innovative OTC products.

Key Provisions

• Authorizes the FDA to collect user fees from OTC monograph drug manufacturers and marketers to support the agency's OTC drug review and regulatory activities
• Establishes a new OTC Monograph Drug Review program to streamline the process for modifying existing OTC monograph orders and approving new OTC monograph drugs
• Requires the FDA to meet performance goals and timelines for reviewing OTC monograph submissions
• Provides the FDA with enhanced authorities to address safety issues with OTC monograph drugs, including mandatory recalls and post-market studies
• Extends certain regulatory exclusivities to incentivize the development of innovative OTC monograph drug products

Affected Parties and Impacts

• OTC monograph drug manufacturers and marketers will be required to pay user fees to the FDA, which may impact product pricing and availability
• Consumers of OTC monograph drugs may benefit from increased safety monitoring, faster product approvals, and more innovative OTC options
• The FDA will receive a stable source of funding to modernize its OTC drug review process and improve oversight of this $32 billion market

Procedural and Timeline Considerations

HR 4273 was reported (amended) by the House Committee on Energy and Commerce and awaits further consideration by the full House of Representatives. If passed by the House, the bill would then move to the Senate for review and potential amendments before a final vote. The user fee program authorized by this legislation would be in effect for 5 years, after which Congress would need to reauthorize it.