The U.S. Food and Drug Administration has defined “small number of animals” for minor use designation under the Minor Use and Minor Species Animal Health Act of 2004.
Previously, the definition of “minor use” relied on the phrase “small number of animals” to characterize such use: “ '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.”
The FDA’s amendment, effective Nov. 9, establishes a specific “small number of animals” for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use. “Small number of animals” means equal to or less than 50,000 horses, 70,000 dogs, 120,000 cats, 310,000 cattle, 1.45 million pigs, 14 million turkeys and 72 million chickens.
“This definition establishes the number of animals eligible to be treated annually based on the number of animals that represents a drug market value that (relative to drug development costs) would not be likely to be pursued in the absence of the MUMS Act incentives,” according to the FDA.
The MUMS Act is intended to make more medications legally available to veterinarians and animal owners to treat minor animal species and uncommon diseases in the major animal species. The act provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species.
Minor species are all animals other than humans that are not one of the major species.