The Senate Committee on Health, Education, Labor, and Pensions voted to adopt a manager's amendment to reauthorize the Over-the-Counter Monograph User Fee Amendments (MUFA), a user-fee program that funds Food and Drug Administration review of nonprescription drugs.

Senator Jim Banks, sponsor of S.2292, said MUFA reauthorization is a "common sense reform" that can make FDA review of nonprescription drugs more efficient; he told the committee MUFA collected about $32,000,000 in user fees in the last year. Senator Eric Husted described the SMART OTC Act included in the manager's amendment as a provision to "make it easier for FDA to approve prescription drugs for over the counter use" by clarifying candidate drug categories and creating a framework for FDA engagement with sponsors.

Senators discussed the dual goals of faster access for patients and maintaining safety. Senator Kim noted she filed an amendment with Senator Banks to ensure the OTC monograph system continues to rely on the "generally recognized as safe and effective" standard, but said she would not force a vote immediately and looked forward to further work. The committee adopted the manager's substitute for S.2292 and advanced the bill with unanimous support recorded on the committee's roll calls.

The committee also acknowledged Senator Paul's amendment on advancing nonclinical testing methods and indicated willingness to work on that policy at a future markup. The panel authorized staff to make technical and conforming changes to prepare the bill text for committee report and floor consideration.