FDA Releases Blueprint to Expand Animal Drug Development for Minor Uses and Minor Species
June 30, 2026
The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) today released its MUMS Blueprint for Success: 2026-2028 , a three-year strategic plan to modernize and expand the Minor Use and Minor Species (MUMS) program. The Blueprint outlines future FDA actions and proposals to improve the availability of safe and effective drugs for underserved animal populations – minor animal species, such as sheep, goats, fish, and exotic species, as well as major animal species like cattle, dogs, cats, and chickens, affected with uncommon diseases for which few or no drugs currently exist.
Since the enactment of The Minor Use & Minor Species Animal Health Act of 2004 (MUMS Act), CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) has worked to reduce the financial and regulatory barriers that historically have discouraged investment in limited-market animal drugs. Progress has been meaningful: 30 designated uses have received full FDA approval (9 supported by the MUMS grant program), 7 conditional approvals have been granted (3 of which have since received full approval), and 18 drugs have been indexed for minor species.
These achievements illustrate what the MUMS framework can deliver, yet significant treatment gaps persist. Veterinarians often rely on extralabel drug use, and for some conditions, no treatment options exist. These gaps can carry real consequences: compromised animal health and welfare, vulnerabilities in domestic food security, reduced agricultural productivity, and diminished U.S. competitiveness in global markets.
The MUMS Blueprint systematically addresses these gaps and identifies opportunities for further growth and development for the MUMS program. The Blueprint’s four strategic goals are shaped by input from across the animal health community, including findings 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.
MUMS Blueprint Strategic Goals for 2026-2028
- Goal 1 - Optimize Existing MUMS Regulatory Frameworks
- Goal 2 - Explore New Pathways to Market
- Goal 3 - Explore New Incentives
- Goal 4 - Enhance Partnerships and Engagement
Closing MUMS treatment gaps will require sustained effort, strong partnerships, and potentially, new authorities from Congress. The MUMS Blueprint for Success: 2026–2028 reflects FDA's commitment to fulfilling its public health mission for all animal species — not only those with the largest commercial markets. FDA looks forward to engaging veterinary, animal health, industry, and academic partners, and will consider seeking new statutory authorities from Congress to deliver more cures for all species of animals.