Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Committee reauthorizes FDA OTC monograph user‑fee program in bipartisan vote, members warn about FDA staffing shortfalls
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…
Already have an account? Log in
Subscribe to keep reading
Unlock the rest of this article — and every article on Citizen Portal.
- Unlimited articles
- AI-powered breakdowns of topics, speakers, decisions, and budgets
- Instant alerts when your location has a new meeting
- Follow topics and more locations
- 1,000 AI Insights / month, plus AI Chat
