Security vendors VeriSign Inc and SupplyScape Corp yesterday announced electronic pedigree interoperability for the US pharmaceutical industry ahead of a forthcoming industry-wide standard.
The US pharma industry needs interoperability to enable e-pedigrees in compliance with upcoming state drug-safety regulations, said the companies.
However, pedigree interoperability may do little to spur adoption of RFID technologies in the pharma industry, as expected, according to a new study.
Pedigree refers to a manufacturers’ ability to trace a shipment’s chain of custody throughout the supply chain, from manufacturing to delivery. Pedigrees are an attempt to stymie drug counterfeiting. In other words, who has the product in their hands – and where and when.
Florida will become the first state that requires all pharma wholesalers to use pedigrees beginning July 1. A similar law will come into effect in California at the start of next year, with 10 other states to follow.
To achieve an intelligent and secure supply chain, our customers must be able to receive electronic pedigrees from their suppliers and transmit pedigrees to their customers, said Jeff Richards, VeriSign VP of intelligent supply chain services, in a statement.
Industry-wide pedigree standards are expected to be ratified this spring.
But this may do little to boost RFID sales in the pharma industry, according to a new report by ABI Research.
No more than about 10 medications will be RFID tagged on a large scale during 2006, said ABI analyst Sarah Shah. This contrasts to an previous industry estimate of a nearly 3.5-fold increase in life-science RFID shipments between 2005 and 2006.
In addition to cost, legislation seems to be the reason for the slowdown. Notably the US Prescription Drug Marketing Act of 1988, which requires companies to prove they have a pedigree in place, said Shah. The act has been put on hold in response to industry uproar that they would not be able get pedigrees in place in time. But the act’s moratorium expires in July.
The FDA also has set a July target for widespread usage of RFID by the pharma industry. Shah said it is now clear that the FDA’s expectations would not be met, as many companies plan to use barcodes and not RFID to satisfy state pedigree laws.
There is a potential that the market will slow more if state pedigree laws are pushed back, says Shah. Initially, only high-value, frequently-counterfeited or stolen drugs such as Pfizer’s Viagra and Perdue Pharma’s OxyContin are likely to be tagged.
VeriSign and SupplyScape said they submitted their pedigree interoperability formats to the standards body EPCglobal’s Pedigree Messaging Work Group in September.
Mountain View, California-based VeriSign and Woburn, Massachusetts-based SupplyScale said they also worked together to clarify business processes related to pedigree adoption.