GPhA: E-Pedigree System Should Be Risk-Based, Workable And Patient-Focused

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist
Article Date: 23 Apr 2008 - 2:00 PDT

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The Generic Pharmaceutical Association (GPhA) commended federal lawmakers for their efforts to establish a uniform, national system to help maintain the security of the drug distribution chain against counterfeit drugs, but said such a system 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. Under the "Safeguarding America's Pharmaceuticals Act of 2008," introduced by Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT), electronic pedigree (e-pedigree) and drug serialization requirements to assist in the tracking and tracing of prescription drugs in the domestic supply chain would be mandated.

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

GPhA strongly supports efforts to ensure the security of the supply chain. Such efforts should follow a risk-based approach that focuses resources on the areas of vulnerability in the supply chain and ensures that counterfeit medicines do not reach consumers.

GPhA noted that there are inherent challenges facing the creation of a tracking and tracing system and urged Congress to work with all participants in the supply chain to ensure that the system is interoperable and reliable. E-pedigree standards should not dictate a particular technology for serialized pedigree. Effective e-pedigree standards should foster innovation and promote competition. Above all, GPhA believes the system must work for consumers.

"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. Most of all, it would harm patients who will be left waiting for their medicines," Jaeger stated. "Due to their low costs, generics are not really targets of counterfeiters. To keep costs affordable, we must work together to create a system that does not lead to less competition, delayed access and higher costs for consumers," Jaeger said.

GPhA has been working with a coalition of members of the entire drug supply chain to develop solutions to strengthen the tracking system. Generic companies and other segments of the supply chain have been conducting pilot studies to figure out what systems might be feasible. "We look forward to working with Reps. Buyer and Matheson on legislation to enhance the safety of our drug supply system," said Jaeger. GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 65% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.

Generic Pharmaceutical Association