(Washington, D.C.) – Consumer Healthcare Products Association (CHPA) Senior Vice President of Regulatory and Scientific Affairs Lisa Parks released the following statement today regarding the U.S. Food and Drug Administration’s (FDA) public meeting addressing suggested recommendations for the reauthorization of the Over-the-Counter Monograph Drug User Fee program (OMUFA) for fiscal years (FYs) 2026 through 2030. Signed into law on March 27, 2020, as a component of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the existing legislative authority for OMUFA will expire on September 30, 2025.
During her remarks, Parks expressed CHPA's appreciation for the opportunity to engage with FDA, while also highlighting the steps the Agency has already undertaken in the pursuit of monograph reform and the fulfillment of its OMUFA I commitments.
“These efforts encompass the release of draft guidance on crucial subjects, serving as a vital tool for the industry during the OMOR review process,” Parks said. “Additionally, the FDA's issuance of deemed final orders for drugs previously categorized as Category I will free up resources for evaluating future changes and submissions. Lastly, CHPA applauds the FDA's efforts in establishing new OTC IT infrastructure and meeting its hiring goals.”
“As we prepare to move into the OMUFA II cycle, CHPA believes we can build upon these accomplishments by focusing on five key points that will play a critical role in ensuring the success of monograph reform. These include:
- Reaffirming that the standard for GRASE determinations is unchanged and should primarily rely on published studies, potentially supplemented by unpublished research, data, and significant market experience;
- Recognizing that GRASE determinations should not resemble NDA-style submissions and review;
- Encouraging FDA to initiate orders where it possesses sufficient data to support GRASE determinations or changes to monographs;
- Enhancing OMUFA meeting efficiencies by granting in-person meetings, providing timely responses, and offering comprehensive guidance based on legal principles, with consideration of the full record, including any relevant OTC panel reviews; and lastly,
- Prioritizing development of administrative orders and guidances for minor changes to dosage forms.”
“CHPA thanks FDA for organizing this public meeting and providing us with the opportunity to share these insights. We anticipate collaborating closely with Congress, FDA, industry, and other key stakeholders throughout the reauthorization process, as we jointly strive to ensure the continued success of the OTC user fee program.”
Background:
Signed into law in March 2020, the CARES Act added sections 744L and 744M of the Federal Food, Drug, and Cosmetic (FD&C) Act, authorizing a new user fee program – known as the Over-the-Counter Monograph Drug User Fee Act (OMUFA) – which reformed and modernized the way OTC monograph drugs are regulated in the United States. CHPA and public health stakeholders supported these reforms, which have provided FDA with additional resources and tools to streamline the monograph process to increase access to quality self-care products for the American consumer.
The current legislative authority for OTC monograph user fee collections expires September 30, 2025, at which point, new legislation will be required to reauthorize the OMUFA program for another five-year term (FY2026 - FY2030).
