On June 30, 2026, FDA’s Center for Veterinary Medicine (CVM) announced the release of the MUMS Blueprint for Success: 2026–2028, a three-year strategic plan outlining potential regulatory, policy, and legislative initiatives intended to strengthen FDA’s Minor Use and Minor Species (MUMS) program. The MUMs program, which is administered by CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS), is intended to encourage development of animal drugs for minor species and for uncommon diseases in major species through a combination of incentives and alternative regulatory pathways.
The blueprint reflects CVM’s enhanced focus in recent years on expanding animal drug availability for minor uses and minor species. As our prior client alerts discuss, CVM has undertaken a number of initiatives aimed at strengthening the MUMS framework, including updating the definition of “small number of animals” used for minor-use determinations and seeking stakeholder input regarding potential reforms to the MUMS indexing framework. The blueprint builds on these efforts by identifying additional opportunities to strengthen MUMS incentives and pathways and facilitate MUMS drug development.
Congress enacted the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) to incentivize the development of new animal drugs intended to treat minor animal species and major species afflicted with uncommon diseases or conditions. The MUMS Act was intended to encourage development of animal drugs for limited markets that historically have struggled to attract investment. The statute, which amended the Food, Drug, and Cosmetic Act, applies to both “minor species”—animals other than dogs, cats, horses, cattle, pigs, chickens, and turkeys—and “minor uses,” which generally involve diseases or conditions that occur infrequently or affect only a “small number of animals” in a major species.
To facilitate such development, the MUMS Act established several regulatory incentives for animal drugs that receive MUMS designation, including seven years of marketing exclusivity, grants to support safety and effectiveness testing, and user-fee waivers. The statute also created a conditional approval pathway that permits marketing based on a showing of safety and a reasonable expectation of effectiveness while sponsors continue generating data to support full approval, and an indexing pathway that allows certain products intended for minor species to be legally marketed without a traditional approval. Together, these incentives are intended to reduce regulatory and financial barriers to product development for limited-market animal drugs.
Since enactment of the MUMS Act, CVM and OMUMS have worked to expand the availability of treatment options for minor uses and minor species. CVM’s announcement states the program has resulted in 30 approved designated uses, 9 of which were supported by the MUMS grant program; 7 conditional approvals, 3 of which have since received full FDA approval; and 18 indexed products for minor species.
In the blueprint, CVM discussed several initiatives to address significant gaps that it states persist in the availability of drugs for minor uses and minor species, addressing four strategic goals that will guide CVM’s efforts to modernize the MUMS program through 2028:
- Goal 1: Optimize Existing MUMS Regulatory Frameworks. CVM plans to maximize the effectiveness of existing MUMS incentives and pathways by reevaluating the “small number of animals” thresholds used for minor-use determinations, developing new indexing guidance, reexamining indexing eligibility criteria for animals such as wildlife, and reviewing the MUMS Grant Program to ensure that its eligible funding categories include the full range of development costs authorized for grant support under the MUMS Act. CVM states that these initiatives can be accomplished within its existing authorities and resources.
- Goal 2: Explore New Pathways to Market for MUMS Products. CVM intends to consider seeking statutory authority for several new regulatory pathways and enhancements, including modifications to the conditional approval framework, an approval pathway that leverages regulatory decisions from trusted foreign regulators with comparable standards, and expansion of the indexing pathway to increase access to legally marketed treatments for minor species, including exploring an indexing process for food-producing minor species that maintains human food safety protections.
- Goal 3: Explore New Incentives to Encourage MUMS Product Development. CVM intends to consider seeking statutory authority to enhance MUMS incentives and introduce new ones. Potential proposals include extending marketing exclusivity, establishing a MUMS priority voucher program, revising major and minor species definitions where appropriate, and expanding eligibility for MUMS incentives to products whose development costs are unlikely to be recovered through U.S. sales within a reasonable timeframe.
- Goal 4: Enhance Partnerships and Engagement. CVM also plans to enhance its engagement with MUMS stakeholders, including academic institutions and other public and private partners, to support MUMS drug development. Proposed initiatives include establishing additional Animal and Veterinary Innovation Center partnerships, increasing the award limit on MUMS grants, exploring new research collaborations, strengthening stakeholder engagement, and increasing staffing and operational capacity within OMUMS.
CVM’s strategy was informed by stakeholder feedback, including recommendations from the Reagan-Udall Foundation’s Transforming Animal Health in the U.S. for the 21st Century report and the AVMA MUMS Roundtable convened in January 2026. We will continue to monitor developments in this space and identify opportunities for engagement with CVM on the implementation of the blueprint.
If you have any questions concerning the material discussed in this client alert, please contact members of our Animal Food and Drug practice.
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