July 21, 2014: Turkish Man Pleads Guilty to Smuggling Counterfeit Cancer Drugs
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
July 21, 2014
United States Attorney
Eastern District of Missouri
St. Louis, MO - Ozkan Semizoglu, the "Foreign Trade Director" of a Turkish drug wholesaler, pled guilty today to smuggling counterfeit, misbranded, and adulterated cancer treatment drugs into the United States, including multiple shipments of Altuzan® (the Turkish version of Avastin®) sent from Turkey to Chesterfield, Missouri. Sentencing is set for October 28, 2014.
According to Semizoglu's plea agreement, Semizoglu used shipping labels that concealed the illegal nature of the prescription drug shipments, including customs declarations falsely describing the contents as "gifts" or "documents" or "product sample" with no or low declared monetary values. Semizoglu also ensured that large drug shipments were broken into several smaller packages to reduce the likelihood of seizures by U.S. Customs authorities and the corresponding loss of expensive drug shipments. Additionally, Semizoglu shipped some prescription drugs that needed constant cold temperatures to maintain their stability and effectiveness in shipping boxes without insulation or any temperature protection whatsoever. Given the length of time required to ship products from Turkey to Missouri, Semizoglu was aware that on many occasions the packages arrived in the United States at temperatures outside the constant cold temperature range discussed on the drugs' labeling.
Further, Semizoglu admitted in his plea agreement to selling Altuzan® to Richard Taylor, a United Kingdom drug wholesaler. The U.S. Food and Drug Administration's ("FDA") Office of Criminal Investigations ("FDA-OCI") previously seized Altuzan® from various physician/customers of Taylor in 2012, and ultimately determined that this Altuzan® from Taylor and Semizoglu was counterfeit, with no active drug ingredient in the drug vials. FDA issued several public safety alerts about these events. FDA-OCI's ongoing investigation has led to a number of related prosecutions in this District, including Dr. Abid Nisar, Sandra Behe, James Newcomb, Richard Taylor, Dr. Erick Falconer, Greg Martin, Kamaldeep Sandhu, and Navdeep Sandhu.
"Today's guilty plea marks a significant step in national and international cooperation," said Philip J. Walsky, acting director, FDA Office of Criminal Investigations. "Federal, state and local officials in the U.S. and Germany and at Europol worked together in partnership to help protect the public's health and remove a potentially unsafe medication from the U.S. marketplace."
This case was investigated by FDA's Office of Criminal Investigations, with assistance from the United States Marshal's Service, Rosa Emilia Rodríguez-Vélez, the United States Attorney for the District of Puerto Rico, the Office of Inspector General for the U.S. Department of Health and Human Services, the Johnson County, Kansas Sherriff's Office Criminalistics Laboratory, Europol, the Bonn prosecutor in Germany (Staatsanwaltschaft); the Federal Criminal Police of Germany (Bundeskriminalamt, BKA); the Dusseldorf Police, the German State Criminal Police (Landeskriminalamt, LKA), the U.S. Department of State's Diplomatic Security Service, the U.S. Consulate General's Overseas Criminal Investigations Branch in Istanbul, Turkey, and the Drug Enforcement Administration.