A pharmaceutical manufacturer pleaded guilty on Wednesday to selling “adulterated drugs” that allegedly endangered active-duty U.S. service members and military veterans.
According to a Department of Justice press release, the Pennsylvania-based KVK Research pharmaceutical company pleaded guilty to “two misdemeanor counts of introducing adulterated drugs into interstate commerce.” The press release noted that KVK Research was fined $1.5 million for the two misdemeanors.
The Justice Department explained that as part of the guilty plea agreement, KVK Research’s corporate affiliate, KVK Tech Inc., agreed to start “a compliance program designed to prevent and detect violations of federal regulations regarding current good manufacturing processes.” KVK Tech will also be required to pay $2 million and cooperate with independent compliance monitoring for three years in order to avoid conviction.
According to the Justice Department, the drug manufacturer admitted that KVK sold at least 62 batches of adulterated hydroxyzine, which is an anti-allergy drug, between January of 2011 and October of 2013. KVK Tech allegedly used an active ingredient in the hydroxyzine tablets that was produced in a foreign facility without receiving proper authorization from the U.S. Food and Drug Administration (FDA).
U.S. Attorney Jacqueline Romero warned, “When adulterated drugs are introduced into interstate commerce, that conduct has the potential to jeopardize patient safety.”
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The Justice Department said both KVK Research and KVK Tech admitted that between February and April of 2019, KVK Tech manufactured prescription drugs without following the necessary regulations. As a result, the sale of the drugs “resulted in alleged false claims submitted” to various federal agencies, such as the TRICARE program. The TRICARE program is a health program designed for active-duty U.S. military personnel, veterans, the Veterans Administration, and families of U.S. service members.
“Protecting the welfare of our nation’s military members and their families is a priority for the Defense Criminal Investigative Service (DCIS), the law enforcement arm of the Department of Defense Office of Inspector General,” Acting Special Agent in Charge Brian J. Solecki said. “The introduction of adulterated pharmaceuticals into the TRICARE system endangers the lives of American service members and threatens our military readiness.”
Solecki noted that the Defense Criminal Investigative Service will continue to work with the Justice Department and other law enforcement agencies to hold companies accountable for engaging in “fraudulent activity, at the expense of the U.S. military.”
