The FDA’s “Counterfeit Drugs Questions and Answers” reports that 10% of the international drug supply is counterfeit with rates as high as 50% in some nations. While the FDA believes the US drug supply is safe, it is working proactively to develop countermeasures with law enforcement agencies like the Department of Homeland Security and the Department of Justice. Its concerns range from the security of “re-imported” (ie Canadian) drugs, recent discovery of counterfeits of drugs like Procrit, and the possibility of bioterrorism.
Proposed solutions include new legislation, further involvement of law enforcement, and technical measures such as RFID. Unique identification of pharmaceutical items would increase the reliability of drug supplies by accounting for all products from the manufacturer to the pharmacy.
“The FDA task force spoke with many leading industry organizations and individuals who believe anti-counterfeiting technologies should be adopted to enhance the nation’s ability to reduce the risk of counterfeit drugs entering the distribution chain and ultimately reaching the consumer. The FDA stated that “authentication” and “track and trace” are two promising types of anti-counterfeiting technologies. Authentication technologies ensure that the drug is real and fall into three categories: overt, covert and forensic. Track and trace technologies include bar code and RFID and can be deployed to help ensure that the real product finds its way safely to the consumer. The report also cites that these technologies are becoming more sophisticated, reliable and inexpensive.
“With issues such as counterfeiting and black market drugs rapidly growing in the U.S., Zebra’s unique technology and combination of multi-layered covert and overt solutions are in-line with the FDA’s anti-counterfeiting report,” explained John Paxton, president of Zebra Technologies. “Our solutions identify and then close gaps throughout the supply chain where counterfeit products are often introduced. This will help protect consumers from fake drugs, as well as help companies avoid losses and brand erosion due to counterfeit and diverted drugs.””