California delays e-pedigree once again

The biggest US state, California, has finally passed its new legislation on securing the prescription drug distribution chain using an electronic pedigree system (e-pedigree).

The deadline for implementing the system has however been extended out to 2015 for manufacturers and 2017 for pharmacists.

Previously, California had introduced a requirement to adopt e-pedigree systems by the beginning of 2011, a timetable considered too short by some industry groups, given the likely cost of implementation and the lack of a national standard. There have also been concerns that implementing a state-level system may in time be superceded by pedigree requirements at the federal level.

A track-and-trace element in a bill designed to reform the federal regulator's operations - added in an amendment to the Safeguarding America's Pharmaceuticals Act of 2008 by Reps Steve Buyer (Republican, Indiana) and Jim Matheson (Democrat, Utah) - has already been the subject of intense lobbying by groups such as the National Association of Chain Drug Stores (NACDS) and National Community Pharmacists Association (NCPA).

The two industry groups recently completed a study which estimated the cost per pharmacy to introduce track-and-trace technology at $110,000. They argue that unlike the food industry - where a recent salmonella outbreak in tomatoes led to a nationwide recall, pharmaceutical product distribution is already heavily regulated and licensed, reducing the need for additional measures at the end of the drug supply chain.

Governor Arnold Schwarzenegger (Republican) has been applauded by both the Generic Pharmaceutical Association (GPhA) and the NNCPA for his decision to extend the deadline.

The GPhA's president, Kathleen Jaeger, said that the reforms are "common sense," noting that counterfeiters rarely target unbranded drugs,mainly due to their low cost.

Radio-frequency identification (RFID) tagging, which was the subject of another bill supported by Gov Schwarzenegger, is one technology proposed for e-pedigree compliance. However it is considered too costly for use, except in the case of the more expensive and counterfeiter-targeted agents.

The NCPA's chief executive, Bruce Roberts, said: "everyone supports the goal of using the still-developing track-and-trace technology designed to limit the fraud and abuse of prescription drugs, but the previous deadline of 2011 was a logistical and financial nightmare for all of the affected parties."