A Colorado corporation that distributes prescription drugs for animals to veterinarians, farms, feedlots, and other facilities has been sentenced on charges of introducing a misbranded drug into interstate commerce.
Animal Health International (AHI) was sentenced through its corporate counsel after pleading guilty to charges this past February. Additionally, AHI's corporate parent, Patterson Companies, entered into a non-prosecution agreement in which it committed to enhance its compliance program and fully comply with the law, the U.S. Food and Drug Administration (FDA) says.
Court documents state that, between 2012 and 2018, AHI distributed prescription veterinary drugs from its wholesale locations to unlicensed individuals. Two of them previously pled guilty to criminal charges for their conduct in United States District Court in Abingdon, Va.
AHI has been ordered to pay a forfeiture of more than $46 million, along with $1 million to the Virginia Department of Health Professionals (DHP) and a $5-million fine.
All amounts have been paid in full pursuant to February's plea agreement, the U.S. States Attorney's Office says, adding AHI was required to make full payment prior to pleading guilty.
Additionally, the company has been placed on probation for one year.
FDA says its restrictions on veterinary prescription drugs are not primarily to protect animals from the potential harms of prescription drugs, but to protect the human food supply from unsafe drug residues in the edible tissues of animals sold for slaughter.
"FDA recognizes the importance of controlling the prescription drug supply for animals," says Mark S. McCormack, a special agent at the FDA Office of Criminal Investigations' Metro Washington Field Office. "The careless or uncontrolled distribution of prescription animal drugs poses a danger, not only to the medicated animals, but to the U.S. public health by increasing the risk that humans will become resistant to antibiotics we unknowingly consume through our food supply."
FDA says Patterson has cooperated in the investigation, adding it has implemented changes to its compliance programs to prevent further violations of federal and state law.
"Manufacturers and distributors of veterinary prescription drugs must ensure these medications are dispensed in accordance with their labels and federal law," says U.S. Attorney, Thomas T. Cullen.
"The Department of Justice (DOJ) will continue to work closely with FDA to investigate and prosecute entities and individuals who engage in these types of unlawful business practices."
