false claims to Medicare program for misbranded, unapproved chemotherapy
drugs; drugs came from Turkey and India through Canada
26, 2014 – The FDA’s Office of Criminal Investigations announced today
that an oncology center in Kentucky has pleaded guilty to selling
unapproved and improperly labeled chemotherapy drugs. The charges
included submitting false claims to the Medicare program for misbranded,
unapproved chemotherapy drugs administered through the clinic. The
successful investigation also serves as a warning to seniors – the most
frequent patients at oncology centers – to investigate carefully before
choosing healthcare providers.
The Hematology and Oncology Center
(HOC) PLLC of Somerset, Kentucky has pleaded guilty to the federal
charges brought by the U.S. Attorney’s Office for the Eastern District
of Kentucky.. 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.
Agents from the FDA’s Office of
Criminal Investigations led this investigation with assistance from the
U.S. Department of Health and Human Services’ Office of Inspector
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
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
These 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 QSP were unapproved and potentially counterfeit.
“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,” said
Philip Walsky, acting director of the FDA’s Office of Criminal
“The FDA is committed to ensuring
that consumers have access to high-quality drugs that are safe and
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for regulating our nation’s food, cosmetics, dietary
supplements, products that give off electronic radiation, and tobacco
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