The case sparked a major effort to crack down on counterfeiting of pharmaceuticals by the US Food and Drug Administration (FDA) earlier this year. The agency is now looking at a number of ways to use technologies to help track pharmaceuticals through the supply chain and prevent the entry of counterfeit or illegally imported products.
The Florida man, Julio Cesar Cruz, faces a three-year jail sentence and a maximum fine of $250,000. Not enough, according to some drug industry observers, who called for the US to rethink sentencing in this type of case on the grounds that this is not enough of a deterrent.
Cruz is accused of supplying 203 bottles of Lipitor, each containing 5,000 10mg tablets, to a Kansas City distributor which then sent them on to a Nebraska-based repacking firm, according to a Department of Justice statement. Some of the drug was genuine Lipitor purchased overseas, while some was counterfeit, said the DoJ. Cruz is alleged to have received more than $1.3 million for the shipment.
"The criminal complaint is part of an investigation of Cruz and others relating to the manufacturing, smuggling and distribution in interstate commerce of counterfeit pharmaceuticals that was launched by the FDA in April," commented US attorney Todd Graves.
Cruz was arrested after another individual, claiming to have been involved in the counterfeiting racket, identified him by name. This material witness said he or she participated with Cruz in a scheme to manufacture counterfeit Lipitor, including the purchase of punches, dies, plates and other items they used to create and manufacture fake tablets.
"This represents a serious and significant public health concern," Graves said. "Counterfeit drugs entering the US marketplace jeopardise the health of the public because these drugs lack any assurance of safety or effectiveness."