Biologics

Regenerative Medicine & Animal Cell-Based Products

Most animal cell- and tissue-based products (ACTPs), including stem cells, meet the legal definition of “drug” because they are intended to treat, control, or prevent a disease or other condition - such as osteoarthritis - or to affect the structure or function of the body - such as improving fertility. Therefore, FDA regulates these products as animal drugs. Purified proteins derived from cells, such as monoclonal antibodies, and products produced by fermentation are also regulated as new animal drugs, provided they meet the definition of a new animal drug. These are not considered to be ACTPs by the FDA. However, government regulatory oversight of animal biologics is not always straightforward. Biological products that generally work through some immunological method or process may be under USDA-APHIS Center for Veterinary Biologics (CVB) jurisdiction instead of FDA-CVM jurisdiction. Depending on the intended use of a biological product, it may be necessary to request a jurisdiction determination from the two agencies. Dr. Hughes is very experienced in working with the FDA for developers seeking FDA approval for marketing their ACTPs. There are some significant differences in the FDA review process for ACTPs compared to antibodies or small-molecule drugs. For ACTPs, there may be unique regulatory considerations that may call for a developer’s interactions with CVM at an earlier stage than would normally take place with traditional products that CVM regulates. Because of this, developers may open a Type VII Veterinary Master File for research and development and risk reviews prior to opening an INAD. The Type VII file provides ways to have confidential exchanges with CVM that are not subject to user fees, earlier and more frequent contact during development, and a route to report research studies outside an investigational file. Additionally, the INAD phased review process for ACTPs starts with a Product Characterization technical section that does not exist for other types of drugs. Much attention is given to donor eligibility to assure that harvested tissues come from only healthy, disease-free animals.