What is the MUMS Act?

The Minor Use and Minor Species (MUMS) Act is a law that aims to help make more medications legally available for treating uncommon diseases in minor animal and major animal species.

What are Minor Use and Minor Species (MUMS) drugs?

According to the US FDA, “Minor Use” drugs are medicinal products that are intended to treat diseases that occur less commonly in “major species” such as dogs, cats, cattle, horses, pigs, chickens, and turkeys. “Minor Species” are all other animals that do not fall under the “major species” categories. These could be sheep, goats, parrots, guinea pigs, ferrets, zoo animals, etc.

What is the importance of the MUMS Act in animal product regulation?

The MUMS Act enables innovative ways to help bring drugs to the US market to treat small populations of animals and helps manufacturers tackle potential roadblocks (i.e., financial) that they experience when trying to provide “limited demand” animal medicinal products. Before the Act was signed into law on August 2nd, 2004, pharmaceutical companies would hardly try to bring these products to the market as the market size was too small and would not generate enough financial return.

The MUMS Act modifies the Federal Food, Drug, and Cosmetic Act in the following 3 aspects:

• Conditional Approval :Animal drug sponsors can apply for “conditional approval” which would enable them to market the drug before collecting all effectiveness data, provided the drug has met safety standards and shows reasonable efficacy. This conditional approval, which can be renewed annually, allows the drug to remain on the market for 5 years while additional efficacy data is collected.”
• Designation :Modeled after the Orphan Drug Act, this provision encourages drug development for rare animal diseases by offering various incentives. Sponsors of the designated new animal drugs can apply for grants for safety and efficacy testing, and if they achieve approval or conditional approval, they receive 7 years of exclusive marketing rights
• Indexing : When a minor species drug is intended for a rare or diverse animal species that cannot undergo the standard drug approval studies, the US FDA can list the drug’s use in the “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species”. This provision aids veterinarians in treating zoo or endangered animals or various species groups.

DDReg’s Capabilities

Navigating the FDA’s MUMS Act requires regulatory expertise and agility – both of which are DDReg’s forte. With a thorough understanding of the MUMS framework, DDReg supports its clients through designation, approval, or conditional approval processes for animal drugs that target rare diseases/conditions or minor species. The team’s experience ensures that animal drug sponsors meet the US FDA’s regulatory criteria thereby facilitating timely access to essential treatments for underserved animal health needs.