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WASHINGTON – The Consumer Healthcare Products Association issued a statement following yesterday’s House Energy and Commerce Subcommittee on Health hearing. Industry experts, including Kevin Menzel, President of Focus Consumer Healthcare and a CHPA member, underscored the importance of reauthorizing the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
During his opening remarks, Menzel emphasized the critical role of OMUFA reauthorization, highlighting CHPA’s commitment to collaborating with Congress, the FDA, and the Administration. He said the reauthorization “will provide FDA with the resources to sustain and evolve the system, while ensuring industry and other stakeholders receive the timely feedback, guidance, and regulatory clarity needed to support innovation and consumer access.”
“CHPA commends the Health Subcommittee for prioritizing OMUFA reauthorization and was pleased to see strong bipartisan support for the program’s continued success from several lawmakers at today’s hearing,” said CHPA President and CEO Scott Melville. “OMUFA has been instrumental in ensuring timely FDA review of OTC medicines, driving innovation, and enhancing consumer safety. It provides the stability, predictability, and certainty needed to ensure an efficient OTC regulatory system, and reauthorization is essential to maintaining a modern framework that empowers American consumers to manage their health with confidence. We look forward to working with Congress to ensure a smooth reauthorization and continued progress for public health.”
The OTC Monograph User Fee Program (OMUFA) modernized the regulation of most OTC medicines, making the previous 40-year-old system more efficient, transparent, and responsive to innovation. Initially authorized in 2020 through the bipartisan CARES Act, OMUFA has provided the FDA with critical resources to update safety information, reduce backlogs, and streamline the approval process for well-established ingredients. With OMUFA set to expire in September 2025, timely reauthorization—OMUFA II—will ensure continued progress and maintain consumer access to safe and innovative OTC medicines.
Yesterday’s hearing featured testimony from:
- Kevin Menzel, Member, Board of Directors, CHPA; President, Focus Consumer Healthcare
- Douglas M. Troutman, Interim Co-Chief Executive Officer, American Cleaning Institute
- Kim Wezik, MPH, Director of Advocacy, Melanoma Research Foundation
- Carl D’Ruiz, MPH, Senior Science, Advocacy, and Business Development Manager, Beauty and Care, North America, dsm-firmenich
- Scott Faber, Senior Vice President, Government Affairs, Environmental Working Group
Click here to view Mr. Menzel’s opening remarks and here for a full transcript of his testimony.
