This update is the last in a multi-part series exploring the FDA’s approval of drugs for pet care.
In part one In our series, we discussed that before an animal drug can be legally marketed for use in animals, a New Animal Drug Application (NADA) for the drug must be approved by the FDA. If the proposed drug product meets certain qualifications, the FDA may offer a company the opportunity to seek conditional approval of the drug.
In second part We examined how expanded FDA conditional approval has the potential to encourage drug development and provide veterinarians with new legally marketed animal drugs to treat serious or life-threatening diseases or conditions and to fill therapeutic gaps where no treatment is currently available.
In this final article, we explore the differences between major and minor species as they apply to FDA approval of a new drug.
What are major and minor species?
According to the FDA, dogs, horses, cats, cattle, pigs, turkeys and chickens are “major species.” “Minor species” refers to all animals other than humans that are not part of the major species. Examples of minor species include zoo animals, ornamental fish, parrots, ferrets and guinea pigs. Other examples of minor animal species considered agriculturally important include, among others, sheep, goats, catfish, game birds, and honey bees.
What does a minor use mean in a major species?
“Minor use” means “the intended use of a drug in a major species for a condition that occurs rarely and in only a small number of animals or in limited geographic areas and in only a small number of animals each year “. The FDA defines a specific “small number of animals” for minor use in each of the major species. For example, a “minor use” for dogs is to treat a disease that affects at least 80,000 dogs per year in the United States.
MUMS law
“The Minor Uses and Minor Species Animal Health Act of 2004,” often referred to as the “MUMS Act,” was signed into law on August 2, 2004. According to the FDA, “the act aims to make more drugs legally available. to veterinarians and animal owners for the treatment of minor animal species and rare diseases in major animal species.
The Act amends the Federal Food, Drug, and Cosmetic Act in three primary ways to provide for conditional approval, designation, and indexing:
CONDITIONAL APPROVAL: The FDA requirements for a conditionally approved NADA are identical to those for a fully approved NADA, except that the effectiveness section of the NADA has reduced the data requirements. Although the data requirements to demonstrate effectiveness are reduced for a conditionally approved NADA. NADA requirements to establish safety and meet manufacturing and product quality standards are the same for a conditionally approved NADA and a fully approved NADA.
Pharmaceutical companies can market a conditionally approved drug after proving its safety and a reasonable expectation of effectiveness, while gathering additional effectiveness data required for full approval.
The “conditional” portion of NADA’s conditional approval states that the drug sponsor has the responsibility to generate, within five years, additional efficacy data required to meet FDA’s substantial evidence standards for full NADA approval. If the drug sponsor fails to gather this evidence within five years, NADA conditional approval status is lost and the drug product can no longer be marketed.
DESIGNATION:
Inspired by the “Orphan Drug Act” for humans, the designation encourages pharmaceutical sponsors to develop drugs for rare diseases, sponsors of new “designated” animal drugs are eligible to apply for grants to support testing of safety and efficiency. They can also request a user fee waiver.
A sponsor who obtains approval or conditional approval of a designated new animal drug receives seven years of exclusive marketing rights, without any competition from another sponsor marketing the same drug in the same dosage form for the same intended use during this period.
INDEXING:
According to the FDA, “a drug intended for a minor species is intended for use in species too rare or too varied to undergo adequate and well-controlled studies to support approval of a drug.” . When this occurs, the FDA may add the intended use to the “Index of New Unapproved Animal Drugs Legally Marketed for Minor Species” (the Index). This provision is particularly useful to veterinarians dealing with zoos or endangered animals – or classes of animals that include many different species, such as ornamental fish. Only minor species that are not used as food for humans or other animals can be included.
Conclusion
Innovative medications often mean new treatment options for veterinarians and their clients, as well as advances in health care for major and minor species. The MUMS Act revises the definition of “small number of animals” for dogs and cats to qualify drugs intended for “minor uses,” from 70,000 and 120,000 to 80,000 and 150,000, respectively. This increase opens the door to more MUMS Act-eligible treatments for these two species.