New legislation, officially named “The Minor Use and Minor Species Animal Health Act of 2004,” dubbed the “MUMS act” for Minor Use/Minor Species, was signed into law on August 2, 2004. The law helps make more medications legally available to veterinarians and animal owners to treat minor animal species and uncommon diseases in the major animal species.
The legislation is expected to benefit people who own small or unusual pets such as guinea pigs or ornamental fish, and it will likely be a great help to zoo veterinarians. The new law provides innovative ways to bring such products to market and is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs. Before this legislation, pharmaceutical companies could rarely afford to bring to market drugs for novel pets and zoo animals, because the markets were too small to generate an adequate financial return.
Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur infrequently or in limited geographic areas and, therefore, affect a relatively small number of animals. Minor species are all animals other than the major species, which includes zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, and honeybees.
The law modifies provisions of the Federal Food, Drug and Cosmetic Act in three key ways.
Conditional Approval: A sponsor of a veterinary drug can ask CVM for “conditional approval,” which allows the sponsor to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the required effectiveness data.
Indexing: In some cases, the potential market for a minor species drug is just too small to ever support the costs of the drug approval process, even under a conditional approval. In such cases, FDA now may add the drug to an index of legally marketed unapproved new animal drugs. This provision will be especially helpful to veterinarians treating zoo or endangered animals or classes of animals that include numerous different species, such as ornamental fish.
Designation: Similar to the “Orphan Drug Act” for humans, which helps pharmaceutical firms develop drugs for limited human uses, this provides incentives for approval. Grants to support safety and effectiveness testing will be available. Companies who gain approval for designated new animal drugs will be granted seven years of marketing exclusivity, which means the sponsor will face no competition in the marketplace for the approved use of the drug for that time.
Questions concerning MUMS should be addressed to:
Dr. Andrew Beaulieu
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7519 Standish Place
Rockville, MD 20855
240-276-9090
mailto:abeaulie@cvm.fda.gov
or
Dr. Meg Oeller,
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7519 Standish Place
Rockville, MD 20855
240-276-9005
mailto:moeller@cvm.fda.gov
