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Senate HELP hearing presses for reauthorization of OTC monograph user fee program
Summary
Acting CDER director Jacqueline Corrigan urged reauthorization of the OTC Monograph User Fee Program (AMUFA), saying the program modernized review of over‑the‑counter drugs but must be renewed to preserve staff and momentum.
The Senate Committee on Health, Education, Labor, and Pensions heard testimony urging Congress to reauthorize the Over‑the‑Counter (OTC) Monograph User Fee Program, commonly referred to in testimony as AMUFA, before it expires at the end of the fiscal year.
Acting director Jacqueline Corrigan of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) told the committee the program has helped modernize OTC review and bring new tools to consumers. "These are the products that millions rely on every day," Corrigan said, and argued that AMUFA'funded staff and processes are needed to maintain safety and continue innovation.
Why it matters: Senators from both parties framed AMUFA as a public‑health and consumer‑protection tool that also affects drug cost and availability. Supporters said the reauthorization would preserve staffing and the new…
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