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House Energy and Commerce hearing urges timely reauthorization of OTC monograph user fee program
Summary
Members and industry witnesses at an Energy and Commerce subcommittee hearing urged Congress to reauthorize the over‑the‑counter monograph drug user fee program (OMUFA/MUFA) before expiration in September 2025, citing predictable funding, improved FDA capacity and industry priorities such as staffing, arrears enforcement and non‑animal testing.
The House Energy and Commerce subcommittee heard broad support from industry, patient advocates and scientists on the need to reauthorize the over‑the‑counter monograph drug user fee program, commonly called OMUFA or MUFA, which the witnesses said strengthened the FDA’s ability to modernize regulation of OTC medicines.
Witnesses, including Kevin Menzel, president of Focus Consumer Healthcare and a board member of the Consumer Healthcare Products Association (CHPA), told the panel that reauthorization is critical to preserve predictability and sustain investments in manufacturing and safety oversight. Menzel said OMUFA ‘‘provided FDA with dedicated resources to implement critical reforms’’ and supported a second five‑year cycle…
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