Oncology Practice Guilty of Purchasing Unapproved Drugs

An oncology practice in Kentucky has pleaded guilty to purchasing and selling unapproved chemotherapy drugs.

An oncology practice in Somerset, Ky. named Hematology and Oncology Center (HOC) PLLC has pleaded guilty to federal charges that the practice purchased and sold unapproved and improperly labeled chemotherapy drugs, the FDA announced. In addition, the practice's former manager, Natarajan Murugesan, pleaded guilty to assisting with the activities, which violate the Federal Food, Drug and Cosmetic Act.

The investigation into the case was led by agents from FDA's Office of Criminal Investigations and the U.S. Department of Health and Human Services' Office of Inspector General. According to FDA, HOC obtained substantial amounts of chemotherapy drugs and other cancer treatment drugs from a foreign drug distributor in Canada operating under the name Quality Specialty Products. The drugs were obtained from Turkey, India, and other locations.

FDA's release said the criminal charges "relate to a civil settlement agreed to in January 2014 by HOC, Murugesan, and N Mullai, M.D. Dr. Mullai was not charged criminally. Under the earlier civil settlement, HOC, Murugesan, and Mullai agreed to pay $2,000,000, plus interest, to resolve charges that they violated the False Claims Act. These charges included submitting false claims to the Medicare program for misbranded, unapproved chemotherapy drugs administered through HOC's Somerset, Kentucky, clinic."

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