The Generic Pharmaceutical Association (GPhA) today pledged its support to a new model, known as the Pharmaceutical Traceability Enhancement Code (RxTEC), for ensuring the security of the U.S. pharmaceutical supply chain.
The RxTEC model, which was developed by the Pharmaceutical Distribution Security Alliance (PDSA) — a multi-stakeholder initiative whose membership, including GPhA, spans the U.S. pharmaceutical distribution system — would increase patient access to safe medicines while improving the security of our country’s drug distribution system.
“As the makers of 80 percent of the prescriptions dispensed in the U.S., the generic pharmaceutical industry is deeply committed to ensuring the security of our country’s drug supply,” said Shawn Brown, GPhA Vice President of State Affairs, in testimony before the House Energy and Commerce Subcommittee on Health. “The RxTEC system is a national supply chain stakeholder consensus model that will replace the patchwork of inconsistent state laws, while increasing patient safety and enhancing our ability to identify and prevent the introduction of suspect product. We urge the inclusion of the proposal in the user fee package to accomplish these goals.”
As part of the RxTEC system, manufacturers have committed to serializing individual saleable units of medicine with RxTEC labels, and maintaining and managing RxTEC data in their systems that would associate the serial numbers on individual bottles of medicine with the lot numbers of products. This system would help identify and prevent the introduction of suspect product through full lot traceability and allow regulatory authorities to validate the serial number of a product at the unit level.
The system would also provide regulators with new authorities and penalties to address counterfeit products, cargo theft and illegal online drug sellers, and new rules regarding e-labeling that will increase patient safety. In addition, it would improve the efficiency and effectiveness of drug recalls and returns, and enable health care providers to leverage technology for record keeping purposes.
GPhA maintains that the RxTEC model offers a better solution than other anti-counterfeiting efforts, such as the drug pedigree model currently set to take effect in 2015 under California law, which would require implementation of full electronic "track and trace" capabilities, where the entire distribution history, and the location, of every unit in the supply chain can theoretically be determined at any time. GPhA believes that adoption of the California model, or one with similar features, would raise the cost of medicine by billions of dollars over time, would be prone to error and would have, at best, similar results to the less-expensive, more efficient RxTEC model.
A copy of Brown’s testimony can be found online here.