AHI Welcomes FDA Action on Unapproved Drugs

(December 14, 2023) AHI welcomes the announcement of the Food and Drug Administration’s (FDA) action to issue warning letters to nine manufacturers and distributors who were marketing unapproved and misbranded antimicrobial animal drugs. This action is consistent with the work done by animal drug companies and FDA’s Center for Veterinary Medicine (CVM) to advance antimicrobial stewardship by ensuring all medically important antimicrobials for use in animals are under veterinary oversight.


FDA-CVM approved pioneer and generic animal drugs are under stringent federal oversight, which gives veterinarians, farmers, and pet owners confidence that the medicine they receive are safe, effective, and properly manufactured, unlike unapproved drugs that carry none of these assurances.  As a result, AHI believes these approved products should be used whenever possible.


In addition, decisions about the use of antimicrobials should be made by a veterinarian with a valid client-patient relationship. Animal caretakers should consult a licensed veterinarian to obtain a diagnosis and determine the best treatment. AHI members are committed to providing veterinarians with the tools they need to protect public health by keeping animals healthy.