Medical Practice Pleads Guilty to Unapproved Cancer Drugs

A medical practice in KY has pleaded guilty to federal charges regarding the purchasing and selling of unapproved and improperly labeled chemotherapy drugs. The charges were brought by the U.S. Attorney's Office for the Eastern District of KY.

Hematology and Oncology Center (HOC) PLLC of Somerset, KY has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC's former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. HOC acquired extensive amounts of chemotherapy drugs and other cancer treatment drugs that were obtained from Turkey, India, the European Union, and other international locations via a foreign drug distributor in Canada. The FDA sent letters in 2012 to medical practices, including HOC, informing them that the cancer medicines purchased from this distributor were unapproved and potentially counterfeit.

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A civil settlement was agreed to in January 2014 by HOC, Murugesan, and N. Mullai, MD, in which they 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 and unapproved chemotherapy drugs administered through HOC's Somerset, KY clinic. The criminal charges relate to this settlement.

For more information visit FDA.gov.

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