The company has agreed to pay more than $10m in criminal fines and forfeiture.
The office of criminal investigations of the US Food and Drug Administration (FDA) investigated the case, in tandem with the Virginia State Police, assisted by the Virginia Department of Health Professions.
“The Department of Justice will continue to ensure that all companies follow federal laws regarding distribution of prescription drugs,” said Christopher R Kavanaugh, the US attorney for the Western District of Virginia. “In this case, millions of dollars were obtained from the illegal distribution of veterinary medicine and, just like pharmaceuticals intended for human-use, my office will continue to hold accountable those companies and corporations that violate federal law.”
According to court documents, from 2011-2021, Midwest shipped prescription drugs from their non-pharmacy locations throughout the US to end-users that were not authorized to receive prescription drugs.
Shipments from non-pharmacy locations to end-users and shipments to non-authorized locations are deemed misbranded.
Midwest shipped at least $10,150,014 worth of misbranded drugs to end-users between 2011-2021. The law violated is designed, in part, to ensure that prescription drugs are kept within a controlled chain of distribution to prevent diversion and inappropriate use.
As part of the plea agreement, Midwest will forfeit $10,150,014 and serve between one- and three-years’ probation. Midwest will also pay $1m to the Virginia Department of Health Professions, and a $500K fine.
The company is scheduled to be sentenced on June 12, 2022, in the US District Court in Abingdon.
In another veterinary drug related case, Otilio Rodriguez Toledo and Alicia Aispuro Hernandez, a couple from California, pleaded guilty in federal court last week to conspiring to smuggle and distribute $2m worth of Mexican pesticides and veterinary drugs that are not approved for use in the US.
In pleading guilty, the defendants acknowledged that since at least December of 2018, they had been engaged in smuggling pesticides and veterinary drugs from Mexico into the US and then distributing them within the country.
The pesticides involved were primarily Taktic and Bovitraz, which are not registered with the US Environmental Protection Agency (EPA) for use in the US. The smuggled veterinary drugs included Tetragent Aves, Metabolase, Terramicina, Cipio Vet, Baytril Max, Tylovet, Caterrol, Penicilina, and Tylosma – again none of those are authorized by the FDA.
In pleading guilty, the defendants admitted that the smuggled pesticides and veterinary drugs were brought in through the Calexico Port of Entry in Imperial County and placed in storage units near the border. The smugglers would send photographs of the products at the storage units as proof of delivery.
The defendants admitted they later picked up the products from the storage units and distributed them to other parties within the US. As part of their plea agreement, the defendants agreed that the value of the smuggled goods was more than $1m but less than $2.2m; they further agreed that the government could seek the forfeiture of up to $2.2m in proceeds obtained from the sale of the smuggled goods.
Public health concerns
According to experts at the EPA and elsewhere, the active ingredient in the pesticides Taktic and Bovitraz is amitraz, which is toxic to bees and humans if it is released into hives and ends up in honey, honeycomb, and beeswax.
Misuse of amitraz-containing products in beehives can result in exposures that could cause neurological effects and reproductive effects in humans, through eating contaminated honey. Signs of neurotoxicity from exposure to amitraz has been documented in multiple animal species, including central nervous system depression, decrease in pulse rate, and hypothermia.
“The FDA regulates animal drugs as part of its mission to protect the public health, which includes ensuring that prescription animal drugs are lawfully distributed and dispensed pursuant to a valid prescription,” said acting special agent in charge, Brian G McClune, FDA office of criminal investigations, Kansas City field office. “We will continue to pursue and bring to justice those who attempt to evade the law.”