Over-the-Counter Monograph Drug User Fee Amendments
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA), which provides funding for the FDA’s review of topical, nonprescription drugs. It revises how fees are collected and calculated, extending the program through fiscal year 2030. The bill also directs the FDA to clarify the process for switching prescription drugs to nonprescription status, including using real-world evidence and engaging with stakeholders, and requires a GAO report on the OTC monograph drug supply chain and the FDA’s handling of drug switching applications.
Key provisions
- Reauthorizes the OMUFA program through FY2030.
- Revises the calculation of OTC monograph drug fees.
- Requires the FDA to allow the use of real-world evidence in evaluating topical, nonprescription drugs.
- Mandates the FDA to clarify the process for switching prescription drugs to nonprescription status.
- Directs the FDA to engage stakeholders in identifying drugs suitable for switching.
- Requires the FDA to issue guidance on nonprescription drug applications.
- Calls for a GAO report on the OTC monograph drug supply chain and drug switching applications.
- Establishes specific fee due dates based on fiscal year.
Who is affected
- Food and Drug Administration (FDA)
- Over-the-Counter (OTC) drug manufacturers
- Consumers of OTC drugs
- Pharmaceutical industry
- Healthcare providers
Bill text
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