House health subcommittee presses for timely reauthorization of OTC monograph user fee program; FDA warns of staffing loss if delay occurs

Chairman Griffith opened the House Energy and Commerce Subcommittee on Health by saying several bills before the panel must be reauthorized to avoid disruptions to health‑care programs, singling out the over‑the‑counter monograph user fee program that Congress created in 2020. “Many of the bills before us expire at the end of this fiscal year and must be reauthorized,” he said.

Why it matters: FDA witnesses and members said the program — enacted as part of the CARES Act to modernize how the agency regulates nonprescription drugs — enabled a shift away from a decades‑old rulemaking approach to an administrative order process, increased transparency, and created a user‑fee stream intended to staff and sustain the work. Without reauthorization, witnesses warned, progress could stall and staff hired under the user fee program could be lost.

Acting director of the FDA’s Center for Drug Evaluation and Research, Dr. Jacqueline Corrigan‑Curay, told the subcommittee the program has produced “five key guidances,” 33 final administrative orders and five proposed administrative orders, and has allowed FDA to hire 85 staff dedicated to OTC monograph work. “With congressional support and timely reauthorization, we have the opportunity to realize the full…