FDA unveils 3-year blueprint to expand drug development for minor uses and minor species

The FDA's Center for Veterinary Medicine (CVM) has released its MUMS Blueprint for Success: 2026-2028, a 3-year strategic plan designed to modernize and grow the agency's Minor Use and Minor Species (MUMS) program. Announced June 30, 2026, the blueprint lays out future actions and proposals intended to improve access to safe, effective drugs for animal populations that drug sponsors have historically overlooked.

The MUMS program serves 2 groups that rarely attract commercial drug development: minor species including sheep, goats, fish, and exotic animals as well as major species such as cattle, dogs, cats, and chickens that are affected by uncommon conditions with few or no approved treatment options.¹

Two decades of progress, but gaps remain

Since Congress passed the Minor Use and Minor Species Animal Health Act in 2004, CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) has worked to lower the financial and regulatory hurdles that discourage investment in limited-market animal drugs. The results to date include 30 designated uses that have earned full FDA approval, 9 of which were supported by the MUMS grant program, 7 conditional approvals (3 of which have since converted to full approval), and 18 drugs indexed for minor species.¹

Despite that progress, the agency acknowledges that significant treatment gaps persist. Veterinarians frequently must turn to extra label drug use, and for some conditions, no options exist at all. According to the FDA, the consequences extend beyond individual patients because these gaps can compromise animal health and welfare, create vulnerabilities in domestic food security, reduce agricultural productivity, and weaken the competitiveness of US producers in global markets.

Four strategic goals

The blueprint is organized around 4 goals for 2026 through 2028:¹

1. Optimize existing MUMS regulatory frameworks. Refining the designation, conditional approval, and indexing pathways already in place.
2. Explore new pathways to market. Investigating additional routes for bringing MUMS drugs to veterinarians and producers.
3. Explore new incentives. Identifying fresh ways to attract sponsor investment in limited-market products.
4. Enhance partnerships and engagement. Deepening collaboration across the animal health community.

The goals were shaped by stakeholder input from across the profession, including findings from the Reagan-Udall Foundation's Transforming Animal Health in the US for the 21st Century report and the American Veterinary Medical Association's MUMS Roundtable, which convened in January 2026.

What comes next

The FDA cautioned that closing MUMS treatment gaps will take sustained effort and strong partnerships—and may ultimately require new authorities from Congress.¹ The agency indicated it will consider seeking additional statutory authority as it works to deliver more approved therapies across all species, and it plans to engage veterinary, industry, academic, and animal health partners throughout the blueprint's implementation.

For practitioners, the plan signals a potential long-term shift: fewer scenarios in which extralabel use is the only option, and a broader formulary for exotic, aquatic, and small ruminant patients, as well as for rare conditions in companion animals and livestock.

The full blueprint is available as a PDF on the FDA's website, along with additional resources on the MUMS program and the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.

Reference

FDA releases blueprint to expand animal drug development for minor uses and minor species. News release. FDA Center for Veterinary Medicine. June 30, 2026. Accessed July 8, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-blueprint-expand-animal-drug-development-minor-uses-and-minor-species