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Kentucky cancer practice guilty of purchasing, selling unapproved chemotherapy drugs
The FDA today reported that a cancer group in Kentucky has pleaded guilty to federal charges of purchasing and selling unapproved and improperly labeled chemotherapy drugs.
Hematology and Oncology Center (HOC) of Somerset, Ky., and former office manager Natarajan Murugesan, pleaded guilty to violations of the Federal Food, Drug and Cosmetic Act. Charges were brought by the US Attorney’s Office for the Eastern District of Kentucky, which reported that the practice obtained the drugs from a foreign drug distributor based in Canada operating under the name Quality Specialty Products.
Agents from the FDA’s Office of Criminal Investigations led this investigation with assistance from the US Department of Health and Human Services’ Office of Inspector General.
“The FDA commends the U.S. Attorney’s Office, Eastern District of Kentucky, for pursuing these allegations and for helping protect U.S. consumers from potentially receiving counterfeit, ineffective, or contaminated medicines,” Philip Walsky, acting director of the FDA’s Office of Criminal Investigations, said in a press release. “The FDA is committed to ensuring that consumers have access to high-quality drugs that are safe and effective.”
The criminal charges relate to a civil settlement agreed to in January by HOC, Murugesan and N Mullai, MD. Under the earlier civil settlement, HOC, Murugesan and Mullai agreed to pay $2 million, 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, Ky., clinic.
The unapproved drugs were obtained from Turkey, India the European Union and other international locations. Often, the drugs arrived at HOC with labels and dosage instructions in foreign languages. In 2012, the FDA sent letters to medical practices, including HOC, alerting them that the cancer medicines they purchased from Quality Specialty Products were unapproved and potentially counterfeit.