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House Energy and Commerce hearing urges timely reauthorization of OTC monograph user fee program
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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 with additional full‑time employees and continued emphasis on surveillance and good manufacturing practice compliance.
The nut graf: the current statutory authority for OMUFA expires in September 2025. Without reauthorization, industry witnesses warned, planned staffing, surveillance and review targets could slow, and the regulatory predictability that underpins investment in U.S. OTC manufacturing could be undermined.
Members and panelists discussed several specific reauthorization priorities. Industry requested that OMUFA 2 maintain the standard of ‘‘generally recognized as safe and effective’’ (GRAS/GRASE), fund an FDA staffing increase the industry’s goals letter proposed (roughly 11 additional FTEs to reach about 112), and give FDA tools to address a roughly 200‑facility arrears list of registered monograph facilities that have not paid fees and which witnesses said correlate with poorer quality records. Menzel told the committee that resolving arrears and targeting inspections at nonpaying or low‑quality facilities would boost program integrity and product safety.
Witnesses also urged maintaining predictable, lean fee structures and clearer FDA‑industry communications to reduce delays. Douglas Trautman of the American Cleaning Institute asked for more timely, informal agency feedback during long studies to prevent regulatory uncertainty. Several witnesses said that OMUFA’s early years were focused on building infrastructure and that the next reauthorization should focus on delivering more final determinations and fostering innovation.
Panelists described consumer and system benefits tied to the monograph system: Menzel and others repeated widely used estimates that increased OTC availability reduces health care utilization and can save health system costs by enabling self‑care for minor ailments. Members from both parties stressed rural access and supply‑chain resiliency as reasons to keep a predictable regulatory pathway.
Ending: Committee members said they planned oversight on the agency and the reauthorization timetable; multiple members asked the administration for assurances that the FDA workforce and funding streams will be preserved so OMUFA can meet its performance goals.
