In the fast-growing field of veterinary regenerative medicine, cellular material — such as living cells, serum, or other products derived from cells — are used in animals with the hope of repairing diseased or damaged tissues or organs. For example, in a horse with tendonitis, the damaged tendon may heal with scar tissue that isn’t as strong or elastic as the original tendon before it was damaged. The goal is to transplant living cells into the injured tendon, hopefully stimulating it to regenerate and heal. Veterinary regenerative medicine is an active area of research for developing new therapies for animals.
Products containing cellular material for use in animals are called animal cell-based products. Animal stem cells are a subset of cell-based products.
Most Animal Cell-Based Products are Animal Drugs
Most animal cell-based products 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. The same laws and regulations that apply to other animal drugs also apply to animal cell-based drugs. FDA must review and approve cell-based drugs before companies can legally market them.
The pre-market review is integral to FDA’s ability to protect animal and public health. During the review, the agency evaluates information submitted by the drug sponsor to make sure the animal drug is safe and effective for its intended use and that the drug is properly manufactured and adequately labeled and packaged. (A drug sponsor is the person, company, university, or other entity working to get a drug approved.) If FDA determines that the data show the animal drug is safe, effective, and high-quality, the agency approves the drug for the uses listed on the label.
Unapproved Animal Drugs
An animal cell-based drug that is marketed without FDA approval is an unapproved animal drug. It is illegal to market an unapproved cell-based drug because it hasn’t gone through the required FDA pre-market review and approval process. Unapproved cell-based drugs may not be safe, effective, properly manufactured, or adequately labeled or packaged. Currently, no animal cell-based drugs are FDA-approved.
In June 2015, FDA issued a guidance for industry (GFI #218), which discusses the approval requirements for animal cell-based products that meet the legal definition of a “drug” and how the agency intends to regulate them.
FDA also sent a letter to all U.S. veterinary schools informing them of the June 2015 guidance. As FDA stated in the letter, veterinary schools that manufacture, market, or investigate animal cell-based products should be aware of the regulatory requirements and their responsibilities regarding these products.
Great Promise but Proof Needed
In recent years, the scientific community has made significant advances in developing cell-based products for use in animals, and scientists continue to research innovative cellular therapies. Veterinary regenerative medicine holds great promise for future safe and effective treatments for many animal diseases and other conditions. However, the ultimate proof rests in obtaining high quality data from well-conducted, well-controlled, and well-designed scientific studies.
To help drug sponsors do this, FDA started the Veterinary Innovation Program, or VIP. VIP is open to sponsors of innovative animal drugs, including certain animal cell-based drugs. The program’s goals are to encourage sponsors to research and develop innovative animal drugs and to help them address the challenges of moving such a drug through the approval process.
To help animal owners, veterinarians, researchers, and the public with access to information on clinical field studies investigating the use of these products in veterinary patients, FDA maintains a listing of Clinical Field Studies for Animal Cells, Tissues, and Cell- and Tissue-Based Products.
Because of the novelty and complexity of animal cell-based products, FDA encourages individuals, universities, and drug companies interested in developing these products to contact the agency at 240-402-7002 or AskCVM@fda.hhs.gov.
- Legal definition of the term “drug:” Section 201(g)(1)(B) & (C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)(1)(B) & (C)]
- Presentation on FDA Guidance 218: Cell-Based Products for Animal Use
FDA issued the following Warning Letters to companies that were illegally marketing animal cell-based products without FDA approval: