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May 23rd, 2008
With public comments in from about 55 sources, the U.S. Food and Drug Administration (FDA) is now proceeding to prepare a recommendation for an electronic pedigree (e-pedigree) system that pharmaceutical makers, distributors and retailers would required to use to identify products as they moved through the supply chain. The track-and-trace solution would be used to not only record which parties handled a drug during shipment, but also verify its authenticity and thwart counterfeiting. The FDA was accepting public comment until May 19, and now it will begin the process of analyzing those comments before making its recommendation as to how drugs would be tracked, what technology and what standards might be used, and who could help create those standards. A spokesperson for the FDA says the agency is still reviewing the responses and could not yet comment on the agency's next step.
In 2007, the U.S. Congress passed the Food and Drug Administration Amendment Act (FDAAA), mandating the FDA to evaluate potential e-pedigree systems and based on that evaluation, to make recommendation by January 2010 (see All Eyes on FDA for Drug E-pedigree). To help guide it in this endeavor, the FDA asked the public which technologies are the most appropriate for a pedigree system, what their strengths and limitations are, how interoperable they are, what standards are necessary and what is the development were of those standards.
Public responses came mostly from health-care industry associations, technology vendors and pharmaceutical distributors and manufacturers, the majority of which recommended RFID technology, with many recommending 2-D bar-coding as a backup up technology in the event an RFID tag failed, and urging the FDA to consider using GS1 standards for either technology. Several vendors of nanotechnology products recommended their own solutions for authentication, while several individuals also responded, stating that any pedigree system was going to be a burden for pharmacies and health-care providers.
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