FDA In Brief: FDA Revises Draft Guidance on Animal Drugs Intended for Minor Uses and Minor Species

SILVER SPRING, Md., July 14, 2020 /PRNewswire/ -- The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine.

"The FDA encourages 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. Today, we are providing revised draft guidance to help facilitate the legal marketing of safe and effective drugs for minor uses or in minor species (MUMS)."

"Many of those seeking approval for MUMS drugs are new to the new animal drug approval process. This draft guidance provides a roadmap for these sponsors to navigate the pathway to legal marketing status for MUMS drugs.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."

"The MUMS program represents our commitment to our continuing mission to help assure that safe and effective animal drugs are available to meet the health needs of a wide range of diverse species, from companion animals and livestock suffering from rare conditions, to addressing the health needs of animals as varied as elephants, honey bees, ferrets and fish."

Additional Information:

• Today, the U.S. Food and Drug issues a revised draft guidance for industry (GFI) #61, "Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,"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).
• 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.

Additional Resources:

• FDA Issues Revised Draft Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species
• Minor Use/Minor Species
• CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species 

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration