Company admitted to introducing and causing introduction and delivery into interstate commerce of misbranded veterinary prescription drugs.

May 5, 2020

4 Min Read
Animal Health International sentenced on federal misbranding charge
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Animal Health International Inc., a Colorado corporation that obtains prescription drugs for animals from manufacturers for further distribution to veterinarians, farms, feedlots and other facilities, was sentenced, through its corporate counsel, in U.S. district court May 4 after previously pleading guilty in February 2020 to introducing misbranded drugs into interstate commerce.

At the time of the guilty plea, Patterson Companies Inc., Animal Health International’s corporate parent, entered into a non-prosecution agreement in which it committed to enhancing its compliance program and fully complying with the law, according to an announcement from the U.S. Attorney's Office in the Western District of Virginia.

Animal Health International admitted to introducing and causing the introduction and delivery into interstate commerce of veterinary prescription drugs that were misbranded. At the May 4 sentencing, pursuant to the agreements entered into by Animal Health International and Patterson, the company was ordered to pay a forfeiture money judgment of more than $46 million, $1 million to the Virginia Department of Health Professionals and a $5 million fine. All of those amounts have been paid in full pursuant to the plea agreement, which required Animal Health International to make full payment prior to pleading guilty, the announcement said. In addition, Animal Health International was placed on probation for a period of one year.

In the past 18 months, Patterson said it has fully cooperated in the investigation and implemented changes to Animal Health International’s and its compliance programs to prevent further violations of federal and state law.

U.S. attorney Thomas T. Cullen and special agent in charge Mark S. McCormack of the Food & Drug Administration Office of Criminal Investigation’s Metro Washington Field Office made the announcement.

“Manufacturers and distributors of veterinary prescription drugs must ensure that these medications are dispensed in accordance with their labels and federal law,” Cullen said. “Unauthorized distribution and off-label use of prescription medications not only endanger animals and livestock but also the general public. The Department of Justice will continue to work closely with FDA to investigate and prosecute entities and individuals who engage in these types of unlawful business practices.”

McCormack added, “FDA recognizes the importance of controlling the prescription drug supply for animals. 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 that we unknowingly consume through our food supply. We will continue to pursue and bring to justice those who distribute prescription animal drugs unlawfully.”

FDA has restrictions on veterinary prescription drugs not just to protect animals from the potential harms of prescription drugs but also to protect the human food supply from unsafe drug residues in the edible tissues of animals sold for slaughter.

Common causes of illegal residues include: (1) exceeding the drug’s approved dose, (2) using a shorter withdrawal period than what is stated on the drug’s label (if a higher-than-approved dose is given, the labeled withdrawal period may not be enough to allow the drug to deplete to levels in the edible tissues that are at or below the tolerance), (3) using a drug in an extra-label manner (for indications and dosages outside the approved labeling) without a veterinarian’s involvement, (4) giving a drug not approved for that species and (5) using an unapproved route of administration.

The announcement explained that, according to previously filed court documents, from 2012 through 2018, Animal Health International caused misbranded veterinary prescription drug shipments to be made throughout the U.S. by distributing veterinary drugs from its wholesale locations directly to end users, by distributing veterinary drugs to unlicensed individuals, by distributing veterinary drugs pursuant to prescriptions issued by a veterinarian who was not licensed in the state to which veterinary drugs were being shipped and by distributing veterinary drugs pursuant to prescriptions issued by a veterinarian who did not have a valid veterinarian/patient relationship with the animals in question.

While the company obtained no less than $46,802,203 from its illegal shipments, its profits from such shipments were a small percentage of the amount received.

The investigation of the case was conducted by the FDA Office of Criminal Investigations with the assistance of the Virginia Department of Health Professions. Assistant U.S. attorney Randy Ramseyer prosecuted the case for the U.S.

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