Inspections, Compliance, Enforcement, and Criminal Investigations
May 11, 2009: Doctor Found Guilty of Smuggling Foreign Cancer Drugs into the United States
An oncologist who maintained offices in Upland and Chino has been convicted of smuggling foreign misbranded cancer drugs into the United States – drugs that were administered to his patients even though they had not been approved by the Food and Drug Administration.
Vinod Chandrashekm Patwardhan, 66, of Claremont, was convicted Friday afternoon by a jury in federal court in Riverside. The jury found Patwardhan guilty of conspiracy, two counts of introducing misbranded drugs into interstate commerce with intent to defraud or mislead, and three counts of smuggling.
The evidence presented during a seven-day trial showed that Patwardhan regularly purchased unapproved cancer drugs from foreign countries including India, Honduras, Panama and the Philippines. From 2004 until his arrest last August, Patwardhan smuggled or caused to be smuggled more than $1.3 million worth of unapproved drugs from foreign countries. The investigation revealed that Patwardhan and his employees made at least 34 trips to foreign countries to obtain drugs that were smuggled into the United States.
Most of Patwardhan’s patients were receiving the unapproved and misbranded foreign drugs, a fact Patwardhan concealed from his patients. As part of his scheme, Patwardhan charged the patients, their insurance companies and Medicare for the unapproved drugs at the same rate that he would charge for FDA-approved drugs, even though he had paid significantly less for the unapproved foreign drugs.
The investigation into Patwardhan began in March 2008 when a member of his staff alerted law enforcement to his activities.
Patwardhan is scheduled to be sentenced by United States District Court Judge Virginia A. Phillips on July 20. At sentencing, Patwardhan faces a statutory maximum penalty of 71 years in federal prison.
Two of Patwardhan’s former employees have pleaded guilty to misdemeanor charges of introducing unapproved new drugs into interstate commerce and are scheduled to be sentenced later this year.
The investigation into Patwardhan was conducted by the Office of Criminal Investigation of the United States Food and Drug Administration, the Department of Health and Human Services, and U.S. Immigration and Customs Enforcement (ICE). The case was referred to these agencies by U.S. Customs and Border Protection.