An Overview of the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA): Policy Areas to Watch

On November 12, 2025, President Trump signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, into law (P.L. 119-37). In addition to enacting fiscal year (FY) 2026 appropriations for the Food and Drug Administration (FDA), Title V of this law, the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA), reauthorized certain provisions originally enacted in the Over-the-Counter Drug Monograph User Fee Act in 2020. As discussed in our previous client alert, reauthorization of this program through FY 2030 has been a key area of focus for Congress with the current authorization expiring at the end of FY 2025 (September 30, 2025).

Policy Provisions to Watch

In addition to reauthorizing the Over-the-Counter Drug Monograph User Fee Act, this law includes action items for the FDA with respect to the agency’s over-the-counter (OTC) drug work in both the monograph and Rx-to-nonprescription drug spaces and also calls for analysis by the Government Accountability Office (GAO) on various OTC drug issues.

• Supply Chain Assessment (Section 6505): This section requires the Government Accountability Office (GAO) to issue a report assessing the supply chain for over-the-counter monograph drugs by September 30, 2027, including the overall stability of the supply chain for these products.
• Advancing Evidence and Testing Standards for Active Ingredients for Topical Administration, Alternatives to Animal Testing (Section 6506): This section includes provisions focused on integrating the use of real-world evidence, as appropriate, when evaluating the generally recognized as safe and effective status of active ingredients used in nonprescription drugs intended for topical administration. It also requires the FDA to consider certain types of nonclinical tests or any other alternative to animal testing that the Secretary deems appropriate, in the consideration of certain drugs intended for topical administration. The FDA is required to issue guidance on these topics not later than November 12, 2026.
• Increasing the Clarity and Predictability of the Process for Developing Applications for Rx-to-Nonprescription Switches (Section 6507): This section clarifies that any person planning to submit an application for an Rx-to-Nonprescription switch may submit a written request to the FDA for a meeting to develop a plan for such an application. The plan should address potential risks to public health and the evidence necessary to support the application, including the design of any necessary studies. Within 18 months of OMUFA's enactment (May 12, 2027), the FDA is required to issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs, particularly in the case of applications for an Rx-to-Nonprescription switch, especially for prescription drugs with well-established safety profiles.
• Plan to Engage with Stakeholders on Switch (Section 6507): This section also requires the FDA to develop and make publicly available on its website a plan to engage stakeholders on the steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for Rx-to-Nonprescription switch. The GAO is required to submit an evaluation on Rx-to-Nonprescription drug switch to the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee not later than November 12, 2026.

What’s Next?

Drug pricing and affordability continue to be active areas of focus for policymakers. Rx-to-Nonprescription switch has also been an area of interest for the Trump administration in the context of their focus on drug pricing. Rx-to-Nonprescription switch was highlighted in a drug pricing Executive Order (EO) issued earlier this year, which called on the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to issue a report providing administrative and legislative recommendations to improve the switch process. The EO specifically called for recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter, an issue that also emerged as a focus for Congress this year and is reflected in OMUFA.

OMUFA’s policy provisions are areas that industry, consumers and Congress are likely to continue to watch as the FDA moves forward with OMUFA implementation. Notably, the FDA’s implementation of the guidance and stakeholder engagement plan called for in the reauthorization may present opportunities for engagement with the agency on these OTC policy fronts. Additionally, given the intersection between Rx-to-Nonprescription drug switch and the Prescription Drug User Fee Act (PDUFA), Congress could also revisit switch when it turns to considering the next PDUFA reauthorization (currently set to expire on September 30, 2027). These considerations may be further informed by the FDA’s implementation of the EO’s switch-related provisions, including any potential forthcoming administrative or legislative recommendations from the agency. Taken together, these dynamics suggest that Rx-to-Nonprescription drug switch will continue to be an active area of policy focus going forward.