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 potential of OTC monograph reform,” she said. “If Congress does not reauthorize AMUFA this year, that momentum will come to a grinding halt.”

Corrigan‑Curay said program milestones include an administrative order that, if finalized, could permit new dosage forms such as chewable tablets and orally dissolving films for certain OTC products, and a proposed order related to sunscreen ingredients. She told lawmakers that without reauthorization, about 44% of the scientists and reviewers working on OTC monograph work would face termination and projects tied to the monograph forecast could be shelved.

Lawmakers pressed technical and policy issues tied to the reauthorization. Representative Diana DeGette, the subcommittee’s ranking member, said she supports a bipartisan reauthorization but warned the committee must balance access and safety. “I have concerns with the sunscreen bill. As drafted, the sunscreen bill undermines the existing bedrock safety and efficacy framework set forth in statute,” she said, adding that she hoped for continued bipartisan work.

The hearing included discussion of several bills linked to the overtime monograph program and broader FDA modernization efforts: HR 4273 (OTC monograph user fee amendments), HR 3686 (Safe Sunscreen Standards Act), and broader measures described as FDA Modernization Act 3 in the hearing record. Representatives and witnesses debated how to speed access to newer sunscreen active ingredients and how best to incorporate new testing approaches, including non‑animal methods and real‑world evidence, while preserving safety standards for systemic exposure and long‑term effects.

On sunscreen specifically, members representing states with high seasonal exposure urged faster access to newer filters and formulations. Representative John Joyce (R‑Ohio) and Representative Debbie Dingell (D‑Mich.) are co‑sponsors of HR 3686, which would direct FDA to consider certain real‑world and alternative testing methods for sunscreen active ingredient evaluation. Corrigan‑Curay said FDA is open to methods that answer safety questions but noted areas where the agency still relies on animal studies for complex toxicology questions and where more validation of non‑animal methods is needed.

Several members and FDA witnesses also raised the role of confidentiality, data expectations and predictability for sponsors. Corrigan‑Curay said AMUFA 2 (the agreement proposed for the next five years) would include steps to improve transparency on fees and exclusivity and to provide clearer guidance on the “generally recognized as safe and effective” standard applied to monograph changes.

Funding and staffing concerns were central to the discussion. Representative Debbie Dingell noted earlier public reports that FDA had reduced staff and that the agency’s ability to carry out reviews relies in part on user fees. Corrigan‑Curay told the subcommittee that lack of reauthorization would lead to immediate impacts on programs, staff, and ongoing proposed orders and guidance work.

What’s next: Committee members repeated interest in rapid, bipartisan reauthorization so FDA can continue implementation work and preserve staff. The program in question and related bills were discussed but not voted on at the hearing. Committee members said they intend to continue negotiation on technical language — particularly around sunscreen review standards, alternative testing methods and data confidentiality — before any markup or floor consideration.

Ending: The subcommittee’s witnesses and members urged reauthorization this year to avoid a lapse that the FDA said would immediately reduce staff and pause work on pending monograph orders. Officials said they will continue to work with the committee on technical changes to ensure both innovation and safety are preserved.