Sabahaddin Akman, owner and manager of Turkish drug wholesaler Ozay Pharmaceuticals pleaded guilty to counterfeit drug charges in Federal Court. Ozay Pharmaceuticals was one of the foreign-based drug exporters responsible introducing counterfeit cancer medications into the secure U. S. drug supply.
Turkish citizen Sabahaddin Akman pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States on August 12, 2014, reports the Department of Justice (DOJ). According to Akman’s plea agreement, as reported by the DOJ, “Akman, through his company and employees, used shipping labels that concealed the illegal nature of the prescription drug shipments, including customs declarations falsely describing the contents as ‘gifts’ with no or low declared monetary values. Some cancer chemotherapy prescription drugs sent by defendant to the United States from Turkey had different lot numbers on the exterior packaging of the drugs than the lot numbers found on the actual vials of the drug inside the packages. Additionally, Akman 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.”
Akman is the second Turkish citizen associated with Ozay Pharmaceuticals to plead guilty to adulterated and misbranded cancer drug charges, according to the Wall Street Journal. In July of this year, Ozkan Semizoglu pleaded guilty to similar charges.
The DOJ reports that Akman’s Ozay Pharmaceuticals was a Turkish supplier that provided misbranded and fake cancer medications to UK-based Canada Drug subsidiary, Richard’s Pharma. According to the DOJ, “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 actually contained mold and water, with no active drug ingredient in the drug vials.”
According to the DOJ, the FDA-OCI’s continuing investigation has led to several other prosecutions for sales and distribution of counterfeit cancer medications, including Dr. Abid Nisar, Sandra Behe, James Newcomb, Richard Taylor, Dr. Erick Falconer, Greg Martin, Kamaldeep Sandhu and Navdeep Sandhu.
“Of all U.S. consumers, those with cancer are among the most vulnerable and most in need of proven effective treatments. To prey on that vulnerability is to exploit the health of those individuals and of the public at large,” said Philip J. Walsky, acting director, FDA Office of Criminal Investigations. “OCI commends its colleagues – international, national, state and local – for their collaborate efforts in bringing this criminal to justice.” Walsky will be speaking at the Partnership for Safe Medicine’s annual patient safety conference on September 18th.
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 Sheriff’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, Istanbul Resident Office.