(Washington, D.C.) – The Consumer Healthcare Products Association (CHPA) released the below statement today following a House Energy and Commerce Subcommittee on Health hearing featuring testimony from Kevin Menzel, President of Focus Consumer Healthcare, a CHPA member company, and other industry experts, to discuss the importance of reauthorizing the OTC Monograph Drug User Fee Program (OMUFA).
During his opening remarks, Menzel highlighted the importance of OMUFA reauthorization, and why CHPA and its members are committed to working with Congress, FDA, and the Administration to ensure the program’s continued success, stating that its 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.”
Click here or on the video above to view Mr. Menzel’s opening
remarks and here for a full transcript of his testimony.
"CHPA commends the Health Subcommittee for prioritizing OMUFA reauthorization and was pleased to see strong bipartisan support for the program’s continued success 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."
Background:
The Over-the-Counter (OTC) Monograph User Fee Program (OMUFA) modernized how FDA regulates most over-the-counter (OTC) medicines – making the 40-year-old system more efficient, transparent, and responsive to innovation. OMUFA was first authorized in 2020 through the bipartisan CARES Act, providing FDA critical resources to update safety information, reduce backlogs, and streamline the approval process for well-established ingredients. With OMUFA set to expire at the end of September 2025, timely reauthorization – OMUFA II – will continue this important progress and ensure Americans have access to safe, effective, and innovative OTC medicines.
Today’s hearing featured testimony from: Mr. Kevin Menzel, Member, Board of Directors, Consumer Healthcare Products Association, President, Focus Consumer Healthcare; Mr. Douglas M. Troutman, Interim Co-Chief Executive Officer, American Cleaning Institute; Ms. Kim Wezik, MPH, Director of Advocacy, Melanoma Research Foundation; Mr. Carl D’Ruiz, MPH, Senior Science, Advocacy, and Business Development Manager for Beauty and Care, North America, dsm-firmenich; and Mr. Scott Faber, Senior Vice President, Government Affairs, Environmental Working Group. Click here to view today’s full hearing and witness testimony.
