Animals Need Drugs Too, But Not Without CVM Approval

January 3, 2024By Sara W. Koblitz & Karla L. Palmer & Riëtte van Laack

Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.  With the growth in pet ownership, the pet health product market has also exploded; a Bloomberg article from March 2023 noting that the growth in the pet industry market “is driven by an increase in spending on pet-related healthcare—including veterinary care, diagnostics, and pharmaceuticals—that has created longer pet lifespans that require more expensive elderly care.”  So, much like humans, pets are living longer and facing the ailments so common to old age.  Enter the FDA’s Center for Veterinary Medicine (“CVM”).

A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984.  Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective.  Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.  CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

To carry out its mission, CVM has the same enforcement tools that the rest of FDA, like CDER and CDRH, have, including the authority to conduct inspections, issue warning letters, seize products, add manufacturers to import alerts, and impose penalties on bad actors.  And CVM certainly exercises that authority.  In late2023, CVM issued nine Warning Letters to distributors of veterinary products for use in aquarium fish and birds.  In all of these letters, CVM alleges that the distributors who “take orders” are selling unapproved drug products—typically for infection control—for use in fish and, in some cases birds.  The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.  The way FDA has explained the risks, which is presumably the reason CVM is taking action at this point, is also interesting: the drugs marketed contain antimicrobials used to treat human disease, and given the development of resistance to antimicrobials in human medicines, FDA has decided “to promote more judicious use of animal drugs containing medically important antimicrobials, including working toward ensuring that these drugs can be used in animals only under the supervision of a licensed veterinarian.”  If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

CVM may not be the flashiest part of FDA, but it’s important to stay abreast of the trends in animal drug enforcement, which are, as evidenced by the language quoted above, related strongly to the use of similar drugs in human patients.  Those of you with pandemic pups (or other pets) should be aware that FDA—specifically CVM—is working hard to keep your furry (or scaly or feathery) friends safe.