GPhA Praises California Governor Schwarzenegger For Signing Workable E-Pedigree System

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 03 Oct 2008 - 4:00 PDT

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The Generic Pharmaceutical Association (GPhA) today praised California Governor Arnold Schwarzenegger for signing into law legislation that will establish an electronic pedigree system in California aimed at helping to maintain the security of the drug distribution chain against counterfeit drugs. The legislation, SB 1307, was sponsored by State Senator Mark Ridley-Thomas, and sets forth electronic pedigree and serialization requirements to assist in the tracking and tracing of prescription drugs in the domestic supply chain.

"This legislation reflects the input of thought-leaders across the entire pharmaceutical supply chain, and as a result of the hard work of the legislature and the Governor's staff, California has taken a major step toward creating a workable electronic pedigree system without harming patient access to affordable medicine in California," said GPhA President and CEO Kathleen Jaeger.

"Under this law, brand and generic manufacturers would commence providing pedigree and serialization of their products in 2015. This implementation deadline will help manufacturers to determine the most cost-effective and efficient approach to establishing an electronic track and trace system," Jaeger added. "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."

GPhA has been working with a coalition of members throughout the entire drug supply chain to develop solutions to strengthen the pharmaceutical tracking system. Generic companies and other segments of the supply chain have been conducting pilot studies to determine what systems would be feasible and workable both for patients and the total health care system.

GPhA has advocated for an approach that would focus resources on the areas of vulnerability in the supply chain to ensure that counterfeit medicines do not reach consumers. "Due to their low costs, generics are not typically targets of counterfeiters. 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. We are pleased that Gov. Schwarzenegger's signature enacts sound legislation that makes such an approach the law in California," Jaeger concluded.

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 66% of the total prescriptions dispensed in the United States, but only 15% of all dollars spent on prescription drugs.

GPhA