On December 17, 2024, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) and the U.S. Department of Agriculture’s (USDA) Center for Veterinary Biologics (CVB) (collectively, the Agencies) published a Charter for the Jurisdiction Determination Process of the USDA CVB/FDA CVM Jurisdiction Committee (the Charter). The Charter clarifies how FDA and USDA work together, through the USDA CVB/FDA CVM Jurisdiction Committee (the Committee), to determine the appropriate agency to regulate certain animal biologicals for which jurisdiction is unclear. The Charter also establishes a reconsideration process whereby the Committee may assess the impact of new circumstances—such as scientifically valid information or substantial changes in the proposed intended uses/ label claims—on the Committee’s initial jurisdiction determination for a specific product. The Agencies intend for the Charter to be used in conjunction with their 2013 Memorandum of Understanding (MOU) establishing which animal biologicals each Agency regulates.
Background
The regulations implementing the Virus-Serum-Toxin Act (VSTA) define veterinary “biological products” as all viruses, serums, toxins, or analogous products at any stage of production, distribution, or sale which are intended for use in the treatment of animals and that act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response.[1] Under the Federal Food, Drug, and Cosmetic Act (FDCA), “drugs” include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, as well as articles (other than food) intended to affect the structure or any function of the body or man or animals.[2] Veterinary biological products are “drugs” within the meaning of the FDCA, but are not subject to FDA’s new animal drug approval requirements so long as they fully conform with the VSTA and its implementing regulations.[3]
On February 4, 2013, FDA and USDA executed a Memorandum of Understanding (MOU) regarding procedures and responsibilities for resolving jurisdictional issues and questions concerning the regulation of certain veterinary biological products. The MOU established a mechanism by which the Agencies could exchange information regarding a particular product or issue, and a standing committee to address the status of new products that raise a jurisdictional or definitional question.
Under the MOU, USDA regulates through its licensing process those articles which meet the regulatory definition of biological products, are intended to diagnose, cure, mitigate, treat, or prevent disease in animals, and work primarily through the immune system. By contrast, FDA regulates as drugs those articles that are intended to diagnose, cure, mitigate, treat, or prevent disease in animals and do not work primarily through the immune system.
Since the Agencies signed the MOU in 2013, the nature of veterinary biological products has evolved. FDA and USDA therefore published a formal Charter on December 17, 2024 which explains the Agencies’ joint approach to making jurisdictional determinations on the regulation of products as either drugs under the FDCA or biological products under the VSTA.
Key Elements of the Charter
The Charter introduces a flow chart detailing the Committee’s general jurisdictional determination process and identifies jurisdictional options when a biological article has multiple intended uses or label claims. It also establishes a reconsideration process whereby the Committee may assess the impact of new circumstances—such as new scientifically valid information or substantial changes in the proposed intended uses/label claims—on a product’s jurisdiction.
Jurisdiction Determination Process
The Charter provides a flowchart depicting the Committee’s general jurisdictional determination process. After receiving a request, the Committee conducts an initial review to determine whether the request contains sufficient and scientifically valid information to make a jurisdictional determination. The Committee considers four criteria: (1) whether the product is a “biological article”; (2) whether the MOU adequately addresses the biological article; (3) the biological article’s mechanism of action; and (4) the biological article’s intended use/label claim.
To be USDA-regulated, a product must be a biological article, i.e., a large, complex molecule or mixtures of molecules that may be of synthetic or natural origin. The Committee then considers whether the MOU adequately addresses that article. If the MOU is silent on the biological article in question, the Committee determines the article’s mechanism of action. To be USDA-regulated, a biological article must act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. FDA regulates biological products having all other mechanisms of action.
The Committee then considers the biological article’s intended use(s) or label claim(s). To be USDA-regulated, a biological article must be indicated for the treatment of disease and not solely the clinical signs associated with a disease or effects on the structure or function of the animal (e.g., fertility, productions claims) that are not consistent with a USDA-regulated biological product. If a biological article has multiple intended uses or label claims—one or more of which will be USDA-regulated and one or more of which will be FDA-regulated—the requester has two options. The requestor can seek licensure from USDA for the biological product claim(s) and approval from FDA for the new animal drug intended use(s) concurrently. Or, it can develop a single product with an intended use or label claim regulated by the appropriate agency. The requestor may later seek additional licensure/approval from the other agency. The Charter does not specify how products making both USDA- and FDA-regulated claims will be regulated with regard to each regulatory agency’s distinct requirements, such as with respect to required labeling and manufacturing controls.
Reconsideration Process
The Charter establishes a reconsideration process that the Committee may use to reconsider a previous decision for unlicensed/unapproved products. Either a requester or the Committee may initiate the reconsideration process when there is new and substantial information that could change the initial jurisdictional determination. The Committee reviews data the requester submits to assess whether there are significant new circumstances, such as a change in available scientifically valid information or substantial changes in intended uses or label claims, and makes a determination based on the data. The Charter is silent with respect to options to appeal the Committee’s decisions.
Requesting a Jurisdiction Determination
Parties interested in obtaining jurisdiction determinations should submit a request to either FDA or USDA. Submitters should provide the names and addresses of all legal entities involved in the manufacture of the product, submit detailed information describing the product and manufacturing principles, the proposed mechanism of action with scientifically valid summary data, and the proposed intended use/label claims plus supporting data, and should include referenced scientific literature, other pertinent information, and permission to share information across Agencies.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
[2] 21 U.S.C. § 321(g)(1).
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