Animal & Veterinary
Minor Use/Minor Species
“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.
“Minor species” are all animals other than humans that are not one of the major species. They include animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, game birds, and honey bees among others.
“The Minor Use and Minor Species Animal Health Act of 2004,” commonly referred to as the “MUMS act”, was signed into law on August 2, 2004. The law 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.
This law provides innovative ways to bring products for these small populations 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 such drugs to market, because the markets were too small to generate an adequate financial return.
The law modifies the Federal Food, Drug and Cosmetic Act in three key ways to provide for:
CONDITIONAL APPROVAL: A sponsor of a veterinary drug for a minor use or minor species can apply 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 in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the remaining required effectiveness data. This provision is managed by the Office of New Animal Drug Evaluation (ONADE), not by the Office of Minor Use & Minor Species Animal Drug Development (OMUMS).
DESIGNATION: This provision was modeled on the “Orphan Drug Act” for humans, which encourages pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for approval. Sponsors of “designated” new animal drugs are eligible to apply for grants to support safety and effectiveness testing. A sponsor that gains approval or conditional approval for a designated new animal drug receives seven years of exclusive marketing rights, which means the sponsor will face no competition from another sponsor marketing the same drug in the same dosage form for the same intended use for that time.
INDEXING: In some cases, a minor species drug is intended for use in species that are too rare or too varied to be the subject of adequate and well-controlled studies in support of a drug approval. In such cases, FDA may add the intended use to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). This provision is especially helpful to veterinarians treating zoo or endangered animals or classes of animals that include numerous different species, such as ornamental fish. This provision is limited to minor species that are not used as food for humans or other animals.
WAIVERS FROM USER FEES: Sponsors of minor use and minor species drug development projects are eligible to apply for waivers from user fees. Although OMUMS determines whether a particular intended use in a major species constitutes a minor use, the waiver request itself is handled by ONADE, not OMUMS.
COMPLIANCE POLICY GUIDE (CPG) FOR EXTRA-LABEL USE OF MEDICATED FEEDS FOR MINOR SPECIES: This guide directs FDA field personnel to make the use of medicated feeds for minor species a low enforcement priority under the stated conditions. Extra-label use of medicated feeds is illegal. This guide does not make extra-label use legal or allow unapproved medicated feeds to be promoted or marketed for these uses. It simply makes it less likely that action will be taken against veterinarians and producers who use medicated feeds approved for use in other species for therapeutic purposes in minor species under the conditions stated in the CPG. Such feeds are to be formulated and labeled in accordance with their approved uses.
OUTSIDE PROGRAMS: There are other government programs that support research directed toward drug approval for minor species. OMUMS works closely with these groups. Links to the websites for some of these are provided on this page under “Resources for You.” You may also find useful links on CVM’s Aquaculture page.
Questions concerning MUMS should be addressed to 240-276-9090.
Laws and Regulations
The Minor Use and Minor Species Animal Health Act of 2004 Final Rule: Designation of New Animal Drugs for Minor Uses or Minor Species 21 CFR Part 516 Subpart B Final Rule: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 21 CFR 516 Subpart C Final Rule: Defining Small Number of Animals for Minor Use Designation
CVM GFI #61 FDA Approval of New Animal Drugs for MUMS(PDF - 432KB) CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions(PDF - 140KB) CVM GFI #200 - SECG for Designation of New Animal Drugs for Minor Uses/Minor Species(PDF - 53KB) CVM GFI #201 - SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species(PDF - 59KB)
Compliance Policy Guides
Public Master File (PMF) Availability
Public Master Files contain information that sponsors can use to support new animal drug approvals. The studies in these files were conducted by public entities, so the information is available for anyone to use. Many MUMS new animal drug applications have used PMFs to support drug approvals.