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Committee reauthorizes FDA OTC monograph user‑fee program in bipartisan vote, members warn about FDA staffing shortfalls
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Summary
The Energy and Commerce Committee voted unanimously to reauthorize the OTC monograph user‑fee program (H.R. 4273). Sponsors said the program speeds review and modernizes the monograph process; several Democrats warned the FDA's recent staffing reductions could hinder implementation.
The House Energy and Commerce Committee on Thursday voted unanimously to report H.R. 4273, the Over‑the‑Counter Monograph User Fee Amendments (AMUFA reauthorization), which funds and sets performance expectations for the FDA’s reformed OTC monograph review process.
Representative Bob Latta and Representative Diana DeGette, co‑leads on the measure, described the bill as essential to modernizing how over‑the‑counter (OTC) drugs are reviewed and shepherded to market. Latta said the program helps ‘‘ensure consumers can access safe, effective, affordable OTC products’’ and that reauthorization is needed before the program’s user‑fee authority expires.
Why it matters
Sponsors said AMUFA’s fees fund critical FDA staff who run the administrative order procedures established after 2020 reforms and allow the agency to work through monograph orders electronically rather than on a paper‑by‑paper basis. Supporters argued reauthorization will help bring product updates and innovations to U.S. consumers faster and reduce burdens on the health‑care system.
Staffing concerns
Several Democrats, including Representative Diana DeGette, applauded the reauthorization but warned that the Trump Administration’s staff reductions at FDA have eroded the agency’s ability to deliver on the program. DeGette and others cited analyses saying layoffs and proposed budget cuts could delay reviews and reduce the number of new drugs reaching patients. Representative Frank Pallone and others urged continued oversight to ensure the agency can hire and retain the personnel required to implement AMUFA performance goals.
Key facts and timeline
- The bill would reauthorize the AMUFA program for another multi‑year period to fund FDA review work tied to OTC monograph orders.
- Sponsors said FDA has begun operating under the new administrative order process and that industry has an initial submission due in early 2026.
- Committee passage was unanimous in the markup; recorded committee vote: 51‑0 in favor of reporting the bill to the House.
What’s next
Sponsors asked for quick floor consideration and for continued bipartisan work on technical improvements. Lawmakers on both sides said they will continue working with FDA to make sure staffing and operational issues do not delay consumer access to safe OTC products.
Representative Latta said the program ‘‘helped modernize an old, inefficient system’’ and urged the committee to move the bill to the House floor for prompt action.
