In the case, federal criminal charges were brought against a Gardena, Calif., man for selling counterfeit Viagra, Cialis and Levitra purchased from counterfeiters in China, according to the officials.
Masaru Yamasato, 44, was arrested Monday following an investigation by the U.S. Food and Drug Administration, Office of Criminal Investigations. Yamasato, who disclosed profiting about $6,000 off the sale of the drugs, was charged with trafficking and sale of counterfeit drugs after buying the drugs on the Internet and trying to resell them, Assistant U.S. Attorney Mark Krause said Tuesday.
Krause, who works in the Los Angeles computer and intellectual property crimes division, said the chemist report isn't public, but a chemical analysis proves the pills had only a fraction of the original drug's active ingredient. "The rest of the pill was not fit for human consumption," he said.
This investigation began Oct. 31, 2005, after United States Customs and Border Protection officers examined a package shipped from China to Yamasato. The package, labeled "samples of plastic," had pills with markings branded Viagra, Cialis and Levitra, but proved counterfeit following tests. Yamasato is scheduled for arraignment on July 10.
Many Americans believe the drug supply chain remains relatively safe. But the U.S. Center for Medicine in the Public Interest estimates counterfeit drug sales will reach $75 billion globally by 2010, up more than 90 percent from 2005, according to the World Health Organization.
A new law in Florida that kicks in July 1, requiring pharmaceutical distributors to document who takes possession of prescription drugs as they travel from manufacturers to retail shelves should help to prevent counterfeit drugs from entering the supply chain.
Many of the top ten drug manufacturers either have deployed radio frequency identification (RFID) projects, or are in the process. "Tagging each bottle enables you to identify exactly where the counterfeit drug comes into the supply chain," said Andy Holman, business development and engineer, Avery Dennison RFID Division, a business unit of Avery Dennison Corp. "You'll also know where and when drugs vanish because each bottle is market with a unique number."
Although states are moving forward to protect residents, it appears the U.S. Food and Drug Administration wants to see companies operating in the drug supply chain move a bit faster.
The FDA last week took steps to prod companies into deploying RFID technology to prevent counterfeit drugs from reaching consumers. Among the measures, the FDA will implement regulations related to the Prescription Drug Marketing Act of 1987, which requires prescription drug distributors to provide documentation at each company from the manufacturer to the retail store.
The FDA will force a measure to safeguard the drug supply by using electronic track and trace technology, such as radio frequency identification technology. RFID creates an electronic pedigree (e-pedigree) for tracking the movement of drugs through the supply chain.
"Companies are using high frequency RFID for item-level tagging, and ultra high frequency RFID for cases and pallets, which gives them better than 99 percent read-rate accuracy," said Paul Chang, associate partner at IBM Global Business Services. "The RFID chips are being integrated into the labels."
Drug manufacturer GlaxoSmithKline Inc., for example, designed its RFID supply chain project with help from IBM, which provides the middleware that GSK uses to collect and filter data from the tags. In May, Cardinal Health Inc. said it would affix RFID labels on brand-name and generic prescription drugs at the company's Printed Components facility in Moorestown, N.J., tracking the unique number on each bottle to verify its authenticity at each step in the supply chain
Cardinal Health's facility in Philadelphia encodes the electronic product code (EPC) data on cases and pallets during the packaging process. From there, products ship to the Cardinal Health distribution center in Findlay, Ohio, where the data is read to authenticate the products. Alien Technology Corp., IBM and VeriSign support the project.
Avery Dennison RFID worked with Wal-Mart Stores Inc. to set up a system that allows the retail chain to tag "class 2 narcotics," such as OxyContin from Purdue Pharma L.P., which works with distributor H.D. Smith to secure its supply chain.