Two individuals were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.
The FDA led a joint international law enforcement operation that culminated in the arrest of two Turkish citizens in Puerto Rico. Along with the FDA and Europol, the international operation involved several German government offices: the Bonn prosecutor, the Federal Criminal Police, the Dusseldorf Police, and the German State Criminal Police. Special agents of the U.S. Department of State’s Diplomatic Security Service assigned to the U.S. Embassy’s Regional Security Office in Ankara, Turkey and the U.S. Consulate General’s Overseas Criminal Investigations Branch in Istanbul, Turkey also played a key role in bringing the operation to a successful conclusion.
“This case shows that those who prey on innocent patients in the United States, even from outside our borders, are subject to criminal prosecution,” said John Roth, director of the Office of Criminal Investigations in the FDA’s Office of Regulatory Affairs. “The assistance of our international partners was critical in carrying out the undercover operation that led to the arrest of these individuals.”
A grand jury sitting for the Eastern District of Missouri indicted the two men on January 16, 2014. The indictment charged the two men with one conspiracy count and three counts of smuggling illegal drugs into the United States. Each smuggling charge carries a maximum penalty of 20 years in prison and/or fines of up to $250,000.
The defendants obtained the illicit drugs and then used shipping labels to conceal the illegal nature of the shipments, including customs statements falsely describing the contents as “gifts,” “documents,” or “product samples” with no or low stated monetary values. They also broke large drug shipments into several smaller packages to reduce the likelihood of seizures by U.S. Customs and Border Protection authorities.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication