OMUFA Reauthorization On Deck as Congress Returns from Recess

In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph drugs, including authorizing the agency to carry out a user fee program in furtherance of this work. Enactment of OMUFA was a significant milestone in the modernization of the regulation of OTC monograph drugs and this year marks the first OMUFA reauthorization.

Congress has been working on legislation to reauthorize OMUFA before the current program is set to expire at the end of the current fiscal year (September 30, 2025). This activity has been primarily focused within the committees of jurisdiction for this issue. Leading up to the August Congressional recess, the Energy and Commerce Committee unanimously approved bipartisan legislation (H.R. 4273) to reauthorize OMUFA. This bill is considered a “clean” reauthorization as it does not include any policy riders.

The Senate Health, Education, Labor and Pensions (HELP) Committee considered and also unanimously approved bipartisan legislation (S. 2292) to reauthorize OMUFA in late July. In addition to reauthorizing OMUFA as the House bill does, the Senate bill goes further and includes additional policy as part of the reauthorization. The Senate bill includes provisions related to the evidence and testing standards for active ingredients intended for topical administration of nonprescription drugs, including requiring FDA to issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards for drugs intended for topical administration. The Senate bill also seeks to increase the clarity and predictability of the process for the development of applications for Rx-to-nonprescription switches, including by requiring FDA to issue guidance on this topic and develop, and make publicly available, a plan to engage stakeholders on steps and factors to consider in identifying approved prescription drugs that may be promising candidates for applications for an Rx-to-nonprescription switch, and a related Government Accountability Office (GAO) report.

Taking actions to spur OTC switches has also been an area of interest for the Trump administration, 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, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter, in a drug pricing Executive Order issued in April. Similarly, moving away from the use of animal testing in drug development has also been another area of focus for the Trump administration, a topic Akin explored in our previous blog post.

Ultimately, the House and Senate will need to approve the same legislation and send it to the President to ensure the continuation of OMUFA beyond its current authorization. As Congress returns from August recess, look for further action in the weeks ahead on OMUFA reauthorization as the deadline for reauthorizing the program approaches. While there are various ways in which the next legislative actions could play out in the days ahead, the bipartisan work on this policy front in both the House and Senate this year demonstrate there is momentum for not only reauthorizing the current OMUFA program but seeking to include additional policy as part of a final OMUFA reauthorization bill.