The FDA today issued a revised draft guidance for industry (GFI) #61, “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” that provides information to help facilitate the legal availability of safe and effective animal drugs for minor uses or minor species (MUMS).
“The FDA encurages the development of safe and effective products to improve the health and well-being of all animals, including those for which there are limited options available because of the relatively small market they represent,” said Steven M. Solomon, Director of the FDA’s Center for Veterinary Medicine. “Today, we are providing revised draft guidance to help facilitate the legal marketing of safe and effective drugs for minor uses or in minor species (MUMS).”
Minor uses are animal diseases and conditions that occur in major species (cattle, pigs, chickens, turkeys, dogs, cats, horses) but are relatively rare or in limited geographic areas, and in a small number of animals. Examples of minor uses include various cancers in dogs or regional occurrences of diseases.
Minor species are species other than horses, dogs, cats, cattle, pigs, turkeys and chickens. Examples of minor species are sheep, goats, bison, deer, finfish, shellfish, honey bees, rabbits, gamebirds, ferrets, laboratory rodents, pet birds, llamas, emus and zoo animals.
The revised draft guidance also explains how animal drug sponsors can qualify for incentives, such as animal drug user fee waivers or eligibility for grants. Under certain circumstances, sponsors can also receive extended exclusive marketing rights.
“Many of those seeking approval for MUMS drugs are new to the new animal drug approval process,” said Solomon. “This draft guidance provides a roadmap for these sponsors to navigate the pathway to legal marketing status for MUMS drugs. Additionally, sponsors who apply for MUMS designation status, a status similar to the ‘orphan drug’ status for human drugs, are eligible for incentives to help defray the costs associated with the approval process, which might otherwise prevent a company from pursuing a new animal drug application.”