Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
December 16, 2013
United States Attorney
Eastern District of Tennessee
Contact: Sharry Dedman-Beard
Public Information Officer
Cancer Clinic Purchased Unapproved Drugs For Three Years
GREENEVILLE, Tenn. - Following a six day trial in U.S. District Court, Greeneville, Tenn. a jury convicted Anindya Kumar Sen, M.D., 65, and his wife and practice manager Patricia Posey Sen, 66, of Greeneville, Tenn., of causing the introduction of misbranded drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act.
Sentencing is set for 1:30 p.m. on Apr. 30, 2014 in U.S. District Court in Greeneville. Both face a possible sentence of up to 29 years in prison and up to $2.9 million in fines.
According to evidence presented at trial, the Sens' medical practice, East Tennessee Hematology Oncology and Internal Medicine (ETHOIM), also known as East Tennessee Cancer and Blood Center, purchased over $3 million in misbranded and unapproved chemotherapy and chemotherapy supportive medications between April 2009 and March 2012. Patricia Sen purchased the drugs through a Canadian business which obtained the drugs through a United Kingdom distributor. The drugs were not approved by the Food and Drug Administration (FDA) for distribution and use in the United States, the drugs having been distributed in Turkey, India, and Europe. Many of the drugs bore names different from the drugs approved for use in the United States, such as Altuzan, MabThera, and Bonviva. Patricia Sen told employees that she was purchasing drugs from Clinical Care because the drugs were cheaper, and records confirmed that the drugs from Clinical Care cost from eighty percent to half the cost of the FDA approved drugs. Because reimbursement by health care benefit programs such as Medicare is fixed at a percentage of the national average sale price of the drug (106% for Medicare), a provider can increase his profits by purchasing cheaper unapproved drugs.
The Food, Drug and Cosmetic Act (FDCA) establishes a "closed" system to protect the safety and efficacy of drugs used in the United States, particularly prescription drugs. Domestic and foreign drug manufacturers must register with the FDA and must list with the FDA all drugs which the manufacturer intends to distribute in the United States. Drugs go through an extensive review process before being approved for distribution to assure that they are safe and effective for their intended use. Drug manufacturers are also subject to inspection of their facilities by the FDA to insure that the drugs are manufactured properly. The FDCA's labeling requirements insure that users, particularly health care providers, have adequate information on the use of the drug, to include information on dangers and side effects. Foreign drugs not approved for use in the United States do not have on their labels and packaging the required information. The listing of FDA-approved drugs allows the FDA to quickly track drugs which may have been found to be contaminated or have some other safety risk. Purchasing unapproved drugs impedes the FDA's ability to track the drugs being used in the United States and thwarts the approval process designed to insure that drugs used in the United States are safe and effective.
Genentech, the U.S. manufacturer of the FDA-approved bevacizumab drug product Avastin®, alerted health care providers in February 2012, that counterfeit versions of the drug had been found in the United States. A nurse at ETHOIM testified that the bevacizumab drug product at the practice, a foreign product labeled Altuzan®, bore the same lot numbers as the suspected counterfeit product. Rather than alert the FDA, Patricia Sen had the drugs mailed back to the United Kingdom on Mar. 8, 2012, the day after news reports aired concerning the FDA's execution of a search warrant at McLeod Cancer and Blood Center in Johnson City, Tennessee.
Law enforcement agencies participating in the joint investigation which led to indictment and subsequent convictions of the Sens included the Federal Drug Administration Office of Criminal Investigation, Federal Bureau of Investigation, and Tennessee Bureau of Investigation. Assistant U.S. Attorney Neil Smith and Special Assistant U.S. Attorney Ben Cunningham represented the United States at trial.