OMUFA Reauthorization: Fiscal Years 2026 - 2030
On March 27, 2020, “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”) (Public Law No. 116-136,) was signed into law. The CARES Act added to the FD&C Act section 505G, which reforms and modernizes the regulation of OTC monograph drugs. The CARES Act also added to the FD&C Act section 744M, authorizing FDA to assess and collect user fees dedicated to OTC monograph drug activities, and accompanying sections 744L and 744N.
The OTC Monograph Drug User Fee Program, which we refer to as “OMUFA,” is modeled after the successful Prescription Drug User Fee Act (PDUFA). Under the OMUFA program, industry-paid fees help support FDA’s regulatory activities related to OTC monograph drugs and FDA agrees to adhere to performance goals negotiated by FDA and industry, including specific time frames for conducting certain OTC monograph activities. The current legislative authority for OMUFA expires September 30, 2025. At that time, new legislation will be required to reauthorize the OMUFA program for future fiscal years.
FDA has begun the statutorily-directed negotiation process for developing recommendations to reauthorize OMUFA for fiscal years (FYs) 2026 through 2030. Minutes from each FDA meeting with industry will be posted here once they become available.
FDA held a public meeting on OMUFA reauthorization on September 28, 2023, with a docket opened for public comment. Additional details are below. A second public meeting will be announced to the public after negotiation meetings with industry have concluded.
Industry Discussions on Reauthorization
- April 9, 2024 (PDF - 184 KB)
- March 26, 2024 (PDF - 203 KB)
- March 12, 2024 (PDF - 187 KB)
- March 5, 2024 (PDF - 185 KB)
- February 27, 2024 (PDF - 181 KB)
- February 20, 2024 (PDF - 179 KB)
- February 13, 2024 (PDF - 173 KB)
- February 6, 2024 (PDF - 197 KB)
- January 30, 2024 (PDF - 155 KB)
- January 23, 2024 (PDF - 165 KB)
- January 16, 2024 (PDF - 233 KB)
- January 9, 2024 (PDF - 233 KB)
- December 19, 2023 (PDF – 177 KB)
- December 12, 2023 (PDF – 147 KB)
- December 5, 2023 (PDF – 198 KB)
- November 28, 2023 (PDF – 177 KB)
- November 14, 2023 (PDF – 128 KB)
Public Meetings on Reauthorization
- Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023