Gov. Schwarzenegger recently signed a bill that extends California’s serialization and ePedigree implementation deadline to 2015 for manufacturers, 2016 for wholesalers, and 2017 for pharmacies. The postponement gives industry more time to prepare, but meanwhile, the supply chain continues to be vulnerable without the ability to track and trace prescription drugs.
The Generic Pharmaceutical Association (GPhA) supported the legislation and welcomed the extra time for manufacturers to comply. “This implementation deadline will help manufacturers to determine the most cost-effective and efficient approach to establishing an electronic track and trace system,” said GPhA President and CEO Kathleen Jaeger in a press release. She explained that generics are not usually counterfeit targets because of their low costs. “To keep the price of medicines affordable, our task is to create a system that would not lead to less competition, delayed access and higher costs for consumers,” she said.
When California announced earlier this year that the 2009 deadline would be pushed back to 2011, respondents in a PharmTech poll said they appreciated the extra time. Now, companies have four additional years to figure out how to implement serialization and ePedigree technology.
Another reason GPhA commended the new legislation is because it does not outline specific technology requirements needed to achieve compliance. “The law is technology neutral, in that it does not dictate a particular technology for serialized pedigree, but allows the manufacturer to determine the most suitable technology solution-this is critical for our industry,” Jaeger said.
But some see the lack of technology standards as a problem. Companies are afraid to spend money to implement a system that won’t work with any other company’s approach. “The 2015 delay will provide all manufacturers with sufficient time for full compliance. However, the industry reluctance is based on lack of a standard that everyone can work toward and know that their investment will serve all states,” said Andre Pino, vice-president and chief marketing officer at Acsis, a provider of supply chain security solutions.
Many states have been watching California’s initiatives in order to consider implement similar requirements. It’s also possible that California’s plan could be adopted as a national standard. “We think that the state of California would have been better served by issuing a call to the pharmaceutical industry to develop a standard that could be used as a template for all states to adopt,” Pino said, adding, “We think a federally developed plan would serve the public and the industry best.”
Despite California’s leadership in developing the serialization and ePedigree requirements, a standard may ultimately be set at the federal level. Section 913 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), titled “Assuring Pharmaceutical Safety,” describes FDA’s plan to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The agency will examine RFID, nanotechnology, encryption technologies, and other track-and-trace or authentication technologies. FDA’s deadline is March 2010.
Just this year, we’ve seen California’s deadline go from 2009, 2011, and now 2015. On the question of another possible delay, Pino said, “Without a national or industry standard it is possible that another delay could occur.”
How long will industry be in limbo waiting for someone to make the first move when it comes to standards? And in the meantime, how much counterfeiting will go unchecked?