GPhA: US e-pedigree rules must not hit access

The Generic Pharmaceutical Association (GPhA) supports the Safeguarding America's Pharmaceuticals Act of 2008, introduced by in the US House of Representatives by Steve Buyer (Republican, Indiana) and Jim Matheson (Democrat, Utah). The aim is to establish a uniform, national system to help maintain the security of the drug distribution chain against counterfeit drugs. However, the GPhA said that the legislation's electronic pedigree (e-pedigree) and drug serialization requirements should be risk-based, driven by technology that works for all participants in the drug supply chain and, above all, does not harm patient access to medicines.

"The protection of our nation's pharmaceutical supply chain is paramount and must be a shared priority. While the US supply chain is the safest in the world, we should always be looking for ways to strengthen patient protection," said GPhA president Kathleen Jaeger.

The GPhA noted inherent challenges facing the creation of a tracking and tracing system. Ms Jaeger said: "a national system should be interoperable and reliable where everyone in the supply chain can communicate effectively and get needed medicines to consumers. A system with multiple technologies would create great confusion within the supply chain."