GREENEVILLE, TN—Anindya Kumar Sen, M.D., 65, and Patricia Posey Sen, 66, of Greeneville, Tennessee, were sentenced on June 10, 2014, by the Honorable J. Ronnie Greer, U.S. District Court Judge, after their convictions at trial in December 2013 on charges of causing the introduction of misbranded drugs into interstate commerce in violation of the Food, Drug, and Cosmetic Act (FDCA). Dr. Sen was sentenced to three years of probation and was ordered to pay a fine of $100,000. Patricia Sen, his wife and practice manager, was sentenced to four years of probation and ordered to pay a fine of $200,000.

According to evidence presented at trial, the Sens’ medical practice, East Tennessee Hematology Oncology and Internal Medicine (ETHOIM), a.k.a. 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 had 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 80 percent to more than 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 percent for Medicare), a provider can increase his profits by purchasing cheaper unapproved drugs. Evidence presented showed that the Sens received approximately $1.3 million in additional profit by purchasing the unapproved drugs.

The 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 March 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.

District Judge Greer, in a written order, found that “overwhelming proof” established that Dr. Sen knew or should have known his practice was using misbranded and unapproved drugs in violation of the law and that “[t]here clearly was a risk of harm to patients from use of the unapproved drugs.” Judge Greer went on to find that “Dr. Sen abandoned his duty and responsibility to assure that his patients received the drugs prescribed and in the dosage indicated to treat their life threatening conditions” and that “Dr. Sen’s conduct was reckless.”

In finding that Mrs. Sen acted with intent to defraud, Judge Greer, in the same order, found that Mrs. Sen knew that only FDA-approved drugs could be used in the practice and that there was nothing to indicate Mrs. Sen made any effort to determine whether the foreign drugs were approved. “Mrs. Sen submitted the claims to health care benefit programs with knowledge, or at least deliberate indifference, that the practice could not be reimbursed for use of unapproved drugs.”

Judge Greer also found that Mrs. Sen had obstructed justice by withholding e-mail messages sought pursuant to a government subpoena in May 2012. Judge Greer stated “[a]n inference can easily be drawn from the e-mails that Mrs. Sen was aware of the fact that the practice had obtained counterfeit drugs, and they were returned to the United Kingdom to put them out of the reach of FDA investigators or other authorities.”

As conditions of probation, Dr. Sen must perform 100 hours of community service, and Mrs. Sen must perform 200 hours of community service. Dr. Sen must also develop protocols to ensure regulatory compliance and provide those protocols to his probation officer as well as submit his practice for inspection by his probation officer to review records of drugs purchased. Mrs. Sen was prohibited from working in any medical practice without the permission of her probation officer and was prohibited from being involved in the ordering of any prescription drugs. Finally, Mrs. Sen was ordered to serve 48 hours in jail as a condition of probation.

Agencies involved in this investigation 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.