Key Takeaways
- The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) share jurisdiction over animal biological products. The two agencies released a Charter for the Jurisdiction Determination Process of the USDA CVB/FDA CVM Jurisdiction Committee to help sponsors determine how their products will be regulated.1
- The Charter sets three criteria to determine which of the two agencies has jurisdiction over a particular animal biological product. It also establishes procedures to request or modify a jurisdictional determination.
- There is no marketing exclusivity for products regulated by the USDA unlike products regulated by the FDA, which means companies developing USDA regulated products must rely on patent exclusivity, including patent term extension (PTE) that may be available, to exclude competitors and protect their significant R&D investment.
On December 17, 2024, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) jointly released a Charter for the Jurisdiction Determination Process of the USDA CVB/FDA CVM Jurisdiction Committee.2
The FDA and USDA share jurisdiction over biologics for use in animals. The USDA Center for Veterinary Biologics (CVB) regulates veterinary biologics under the Virus-Serum-Toxin Act, while the FDA Center for Veterinary Medicine (CVM) oversees new animal drugs under the Federal Food, Drug, and Cosmetic Act (FDAC).3
The Charter provides manufacturers with a process to determine which agency has oversight of a particular biologic for use in animals. It builds on a longstanding Memorandum of Understanding (MOU 225-05-7000)4 between the two agencies but has been updated for regulatory developments since the MOU was signed in 2013.5
The FDA and USDA set three criteria6 to determine which agency has jurisdiction:
- Product type—whether the product qualifies as a “biological article,” such as a vaccine, an antibody, or an immunostimulant. An animal health product that does not qualify as a biological article is regulated by the FDA.
- Mechanism of action—biological articles that act primarily through the immune system will be regulated by the USDA, while those with non-immunological or undefined mechanisms are regulated by the FDA.
- Intended use or label claim—USDA regulates biological articles that are indicated for the treatment of disease in animals, including prevention, diagnosis, management, or cure of disease. But biological articles that do not treat an underlying disease, such as treating symptoms, or that increase fertility or production are regulated by the FDA.
Products may also be split between the agencies, for example, where a product has multiple intended uses. In these cases, a sponsor can pursue approval from both agencies, or consolidate development under a single regulatory framework.7
The Charter provides a flowchart to assist sponsors in applying the criteria and describes how to request a formal determination of jurisdiction.8 There is also a reconsideration process for situations where product changes or new scientific information may alter a prior determination. Reconsideration can be initiated at the sponsor’s request or by one of the agencies.9
A sponsor of a biological article regulated by the FDA receives regulatory exclusivity during which time no generic or modified version of the product can be approved. Under the FDAC, regulatory exclusivity is five years for a new animal drug, seven years for a minor use and minor species (MUMS) animal drug, and three years for new use of an existing active moiety based on substantial new safety or effectiveness studies.10 However, sponsors of biological articles regulated by the USDA do not receive regulatory exclusivity, even though the licensing timeline for a USDA regulated product can be the same as products regulated by the FDA. This means that sponsors of biological articles regulated by the USDA must rely on the exclusivity from patents, including any PTE that may be available, to exclude competitors and protect significant R&D investment.11
Shared jurisdiction between the FDA and USDA can be frustrating and confusing for animal health sponsors. While the Charter does not solve these problems entirely, it does create more regulatory clarity and give sponsors a set of tools they can use to better assess what requirements will apply to their products.
Sponsors developing products that may be regulated by the USDA and the FDA may consider consolidating development under the FDA to take advantage of marketing exclusivity that may be available. Although sponsors of all regulated products should implement a comprehensive patent lifecycle management strategy to protect R&D investment, this is especially important for sponsors of USDA regulated products for which no marketing exclusivity is available.
[1] U.S. Food and Drug Administration and U.S. Department of Agriculture, Charter for the Jurisdiction Determination Process of the USDA CVB/FDA CVM Jurisdiction Committee (Dec. 2024), https://www.fda.gov/media/184357/download?attachment.
[2] Id.
[3] Id.
[4] U.S. Food and Drug Administration and U.S. Department of Agriculture, Memorandum of Understanding 225-05-7000 (Aug. 2024), https://www.fda.gov/about-fda/domestic-mous/mou-225-05-7000.
[5] U.S. Food and Drug Administration and U.S. Department of Agriculture, Press Release, FDA and USDA Announce Charter to Clarify Jurisdiction for Animal Biologicals (Dec. 17, 2024), https://www.fda.gov/animal-veterinary/cvm-updates/fda-and-usda-announce-charter-clarify-jurisdiction-animal-biologicals.
[6] Charter, note 1 above, at 2-4.
[7] Id. at 4.
[8] Id. at 5.
[9] Id. at 6-7.
[10] 21 U.S.C. §§ 360b(c)(1)(F)(i), 360ccc-2(c)(2)(A), 360b(c)(2)(F)(ii).
[11] 35 U.S.C. §§ 156(g)(5)(B), (f)(2)(B).