Late last week, the FDA Center for Veterinary Medicine (CVM) published a Federal Register Notice seeking comments on its policy regarding eligibility for “indexing” of certain drugs under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). Comments are due by September 22, 2021. Animal health companies that make, or whose pipeline contains, drugs intended for minor species should consider submitting written comments.
Indexing under the MUMS Act is a mechanism by which animal drugs intended for minor species (those other than cattle, horses, swine, chickens, turkeys, dogs, and cats) can be recognized as lawful for use without having to undergo the full animal drug approval process. This mechanism exists because certain drugs for minor species or for minor uses (MUMS drugs) do not justify the cost of obtaining a full approval.
The MUMS Index is a list CVM has established that includes those MUMS drugs that have met the indexing criteria. The regulations governing indexing of MUMS drugs are in 21 C.F.R. part 516, subpart C. There are currently 14 drugs on the MUMS Index. Adding a new drug to the Index requires review by both FDA and a qualified expert panel review, wherein FDA reviews information on environmental safety, human user safety, manufacturing processes, and human food safety. The expert panel then evaluates target animal safety and effectiveness for the intended use. If CVM agrees with the expert panel’s conclusions, the drug is added to the MUMS Index.
Section 572(a)(1) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 360ccc-1(a)(1)) states that the MUMS Index is limited to (1) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals and (2) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species. CVM explains in its Guidance for Industry 210, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” that it deems a minor species to be a food-producing minor species when some of its members are bred, cultured, farmed, ranched, hunted, caught, trapped, or otherwise harvested for the purpose of having the animals or edible products of the animals commercially distributed for consumption by humans or food-producing animals in the U.S. CVM considers an animal to be food-producing if any member of that species is raised to be food for humans.
CVM has received requests from stakeholder groups to establish criteria that, if met, could determine that MUMS drugs intended for a subset of animals within a food-producing minor species are eligible for indexing because animals within the subset are not consumed by humans or by food-producing animals. Such a policy change would allow more MUMS drugs for minor species to be indexed. In response to this stakeholder request, CVM is considering changing its current policy on eligibility for indexing, and therefore promulgated a request for comments on the following questions:
1. What are the reasons we should or should not expand eligibility for indexing to certain discrete subsets of food-producing minor species?
2. If you support the expansion of indexing, please describe the information we should evaluate when determining which discrete subsets of food-producing minor species should be eligible.
3. Are there any discrete subsets of food-producing minor species that you believe should be eligible for indexing because they are not intended for consumption by humans or food-producing animals?
We believe that animal health companies that make or develop drugs for minor species should consider submitting written comments.
If the Covington Animal Food and Drug regulatory practice can be of assistance, please do not hesitate to reach out to the team contacts.
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