The U.S. Department of Justice (DOJ) announced Wednesday that an eastern Pennsylvania-based pharmaceutical company has admitted to selling adulterated drugs that federal prosecutors say endangered the lives of active-duty military and veterans. .
According to reports, KVK Research pled guilty to “two misdemeanor charges of introducing adulterated drugs into interstate commerce” and was fined $1.5 million. Department of Justice statement. The company's affiliate company, KVK Tech Inc., has implemented a “compliance program aimed at preventing and detecting violations of federal regulations regarding current good manufacturing processes,” and is seeking a three-year period to avoid conviction. The company has agreed to submit to independent compliance oversight, the statement said. KVK Tech will also reportedly pay $2 million.
According to the Justice Department, the companies admitted that KVK Tech sold more than 62 batches of adulterated hydroxyzine, an anti-allergy drug, between January 2011 and October 2013. KVK Tech reportedly sourced the active ingredient for its hydroxyzine tablets from a foreign facility and did not seek approval from the US Food and Drug Administration (FDA).
According to the company, the de facto owner KVK Tech and its quality assurance manager were indicted on June 11, 2021. statement From the United States Attorney's Office for the Eastern District of Pennsylvania. KVK Tech said: On the same day, it claimed the allegations were “without merit.” (Related: Court upholds decision to permanently ban pharmaceutical company president)
Generic drug manufacturer pleads guilty and agrees to pay $1.5 million in criminal penalties for distributing adulterated drugs and $2 million to settle civil liability under the False Claims Act
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— Department of Justice, Civil Division (@DOJCivil) March 6, 2024
According to the statement, the companies also allege that KVK Tech manufactured prescription drugs without complying with current Good Manufacturing Practice regulations at certain manufacturing steps between February 27, 2019 and April 16, 2019. It is said that he admitted that. The sale “allegedly resulted in the filing of false claims” with some federal agencies. tricare programa health program for active duty and retired military personnel, their families, and the Department of Veterans Affairs.
According to the newspaper, Brian J. Solecki, Acting Special Agent in Charge of the Defense Criminal Investigative Service (DCIS) Northeast Field Office, said, “The introduction of adulterated drugs into the TriCare system puts the lives of U.S. military personnel at risk.'' “This threatens our nation's military readiness.” statement.
“When adulterated drugs are introduced into interstate commerce, this action can jeopardize patient safety,” Jacqueline C. Romero, U.S. Attorney for the Eastern District of Pennsylvania, said in a statement.
Solecki added, “DCIS is committed to working with the Department of Justice and our law enforcement partners to ensure that companies that engage in wrongdoing at the expense of our military are investigated and prosecuted.”
