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Pharma Ponders a Track-and-Trace System
At last week's RFID Track and Trace Health Care Summit, there was a great deal of focus on what state governments and the FDA will require the pharmaceutical industry to do, and less emphasis on the business value of RFID.
Nov 24, 2008—Last week, I was invited to speak at the RFID Track and Trace Health Care Summit, held each year by the Health Care Distribution Management Association and the National Association of Chain Drug Stores. The pharmaceutical industry drew a collective sigh of relief when California decided to delay its pedigree requirements until 2015, so I was encouraged to see that some in the industry are still interested in exploring RFID's potential to capture electronic pedigree data automatically—until I realized most aren't.
Jeffrey E. Shuren, associate commissioner for policy and planning at the U.S. Food and Drug Administration (FDA), said the agency believes "the existing supply chain safety system for FDA-regulated products is not adequate," and that there needs to be "a paradigm shift in supply chain safety." The role of electronic track and trace will be critical, he told attendees. The U.S. Congress requires the FDA to publish guidelines in March 2010, and according to Shuren, there is continued activity in Congress that could require the agency to take a more proactive role in establishing track-and-trace requirements.
Rudolf's argument was that since California had spent a great deal of time and energy over the past 12 months building a consensus among drug manufacturers, distributors and retailers, it would make no sense for other states to begin all over again with industry meetings and hearings. Like California, most states won't require radio frequency identification, though that will likely be the most cost-effective way to collect e-pedigree data on individual units of drugs, because scanning bar codes on each unit would be too costly.
At the meeting, I got the feeling many attendees were there to hear the latest regarding which regulation is in the offing, and that they were happy to learn that no regulation is imminent. There was little discussion of the potential business benefits of employing RFID and 2-D bar codes for track and trace. I would have thought CEOs of large drug companies would be deeply concerned about what could happen if, for instance, 50 people were to die from taking counterfeit versions of their drugs. What would be the impact on their brand, and how would they reassure the public that the pharma supply chain is safe? It seems they're assuming that will never happen, and I hope it doesn't—but the possibility remains, especially given what's happening with goods coming from China.
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