Event Title

Reauthorization of the Over-the-Counter Monograph Drug User Fee Program

June 4, 2025

Introduction

Chair Cassidy, Ranking Member Sanders, and Members of the Committee, thank you for the opportunity to testify today on the reauthorization of the Over-the-Counter Monograph Drug User Fee Program, commonly referred to as OMUFA.  

Over-the-Counter (OTC) drugs have long provided an effective, low-cost way for Americans to take care of everyday health needs without having to visit a doctor and obtain a prescription, saving American consumers time, effort, and money. Nonprescription drugs, including those for allergies, pain, fever, and various other ailments are widely available through online and retail outlets, providing safe and effective healthcare options to American consumers nationwide.  One powerful example of the impact of nonprescription drugs are the approvals of naloxone nasal spray, which is used to reverse opioid overdoses. Availability of this medication without a prescription allows this life-saving medication to be sold directly to American consumers in drug stores, convenience stores, grocery stores, gas stations, and online. Although regulated under an approved application rather than the OTC monograph system, this example demonstrates how critical nonprescription products can be to individuals’ lives and public health.

The work of this Committee, leading to enactment of OTC monograph reform and OMUFA in 2020 laid critical groundwork, establishing a long overdue, transformational framework for modernizing the regulation of many over-the-counter drugs.   Now, with congressional support and timely reauthorization of OMUFA, we have the opportunity to realize the full potential of the OTC monograph reform program – ensuring a more nimble regulatory process, fostering innovation to better serve patients and consumers, and enhancing transparency and accountability from FDA and industry. 

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