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FDA reviews veterinary regenerative medicine and animal cell-based products
Currently, no animal cell-based products are FDA-approved, the agency says.
In the fast-growing field of veterinary regenerative medicine, says the U.S. Food and Drug Administration (FDA), 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, the FDA says. The goal is to transplant living cells into the injured tendon, stimulating it to regenerate and heal. 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, according to the FDA. Animal stem cells are a subset of cell-based products.
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, the FDA says. Therefore the agency regulates these products as animal drugs.
Before cell-based drugs can be legally marketed, they must be reviewed and approved by the FDA.
An animal cell-based product that is marketed without FDA approval is an unapproved animal drug. The agency emphasizes that it is illegal to market an unapproved cell-based product because it hasn't gone through the required review process and may not be safe, effective, properly manufactured or properly labeled. Currently, no animal cell-based products are FDA-approved, the agency says.
In June 2015, FDA issued Guidance for Industry (GFI) No. 218, which discusses the approval requirements for animal cell-based products that meet the legal definition of “drug” and how the agency intends to regulate them.
The FDA also sent a letter to all U.S. veterinary schools informing them of the June 2015 guidance. The FDA stated in the letter that veterinary schools that manufacture, market or investigate animal cell-based products should be aware of the regulatory requirements and their responsibilities regarding these products.
In recent years, the scientific community has made significant advances in developing cell-based products for use in animals, the FDA states, but the ultimate proof rests in obtaining high-quality data from well-conducted, well-controlled and well-designed scientific studies.
Because of the complex nature of these products, the FDA is encouraging individuals, universities and drug companies interested in these products to contact the agency at 240-402-7002 or AskCVM@fda.hhs.gov.