Minor Use/Minor Species

“Minor use” drugs are for intended uses in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually. “Minor species” are all animals other than humans that are not one of the major species. They include animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, game birds, and honey bees among others. The Office of Minor Use and Minor Species Animal Drug Development was established as mandated by the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. It is the smallest Office in the Center for Veterinary Medicine and its mission is similar to the Office of Orphan Products for human drugs and devices. The Office makes “minor use” determinations for intended uses in major species (horses, cattle, pigs, dogs, cats, chickens, and turkeys). Minor use status makes a new animal drug intended for such use eligible for designation, for conditional approval, and for waivers from user fees. The Office “designates” qualified new animal drugs for specific minor uses or for specific intended uses in minor species (all species that are not major species). The incentives for designated new animal drugs include grants to support MUMS drug approval or conditional approval and seven years of exclusive marketing rights after approval or conditional approval. OMUMS is responsible for establishing and maintaining the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). Indexing is an alternative process to the FDA approval process to allow legal marketing of drugs for certain non-food minor species and non-food early life stages of food producing minor species. OMUMS also houses the FDA Liaison to the USDA’s National Research Support Project #7 (NRSP-7). NRSP-7 conducts studies that can be used by pharmaceutical sponsors to support FDA approval of new animal drugs for use in minor species of agricultural importance. Outreach to stakeholders is another important function of OMUMS.