On three separate occasions in recent months, the Food and Drug Administration nabbed counterfeit drugs off the Internet—from 24 different Web sites. On a global scale, more than 10 percent of the drugs sold around the world are counterfeit, according to the World Health Organization. The problem, in existence for years, appears to be worsening.
In steps ePedigree, a legislative concept thats being kicked around at both state and federal levels to combat phony drugs entering the U.S. supply chain. The idea is simple: require the electronic—or paper—documentation of a drugs life cycle as it moves through the supply chain from manufacturer to consumer. Putting the concept to practical use is another story.
In 2004, the FDA identified serialization—or the establishment of a computerized life cycle—as the single most powerful tool to secure the U.S. drug supply. It named RFID (radio-frequency identification) as the most promising technology for implementing serialization and set 2007 as the deadline for those in the pharmaceutical industry to widely adopt the technology. Then a 2006 federal court ruling blocked the FDAs ePedigree mandate. The court agreed with some small drug wholesalers that argued that the statute put undue pressure on them to implement compliance technology, while exempting the three largest distributors.
However, by November 2006, 10 states had passed ePedigree legislation. A Florida law was the first to go into effect in July 2006, and a California law will go into effect in 2009. Both recommend either bar code or RFID as a technology choice to enable ePedigree.
Despite strong recommendations from the FDA and states that RFID be the standard for ePedigree, neither federal nor state governments have gone so far as to mandate the technologys use. That leaves companies looking to comply with ePedigree mandates in a quandary, scrambling to determine not only which technology to implement—some form of bar code or RFID—but, in the case of RFID, which frequency standard to adhere to.
To help clear up the quagmire surrounding ePedigree, EPCglobal ratified its electronic pedigree standard in January. The standard looks to provide the pharmaceutical industry with a common format that can be used to collect pedigree information and that software vendors can use to build ePedigree solutions. The EPCglobal standard, like state and federal ePedigree mandates, does not specify RFID as the go-to technology; it also includes bar code and other technologies.