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RFID: FDA unhappy with progress in pharma

Might the FDA set a mandatory RFID standard? Comments from a February 8 and 9 meeting make it likely. On February 8 and 9, the Food and Drug Administration sent a signal on RFID to the pharmaceutical industry, which companies clearly received. "I am disappointed at the apparent slowdown in RFID implementation," stated acting FDA commissioner Andrew von Eschenbach at a meeting of the FDA Counterfeit Drug Task Force in Bethesda, MD. Eschenbach asked the task force to figure out what was slowing down drug companies on RFID and to make recommendations to him by May. Based on the comments of the members of the task force, who are all FDA legal, regulatory, and enforcement officials, it seems very likely the FDA will develop a mandatory standard requiring pharmaceutical companies to adopt RFID tagging in a phased manner, with the highest-risk drugs going first.

Eschenbach emphasized: "The longer we delay, the more opportunity is lost." The FDA issued a task force report in February 2004, which said the agency expected widespread adoption of RFID tagging of drugs in 2007 based on what technology and drug companies were saying at the time. Two years later, Pfizer is the only brand-name company to put tags on a drug in commercial distribution, that being Viagra. Some generic companies selling to Wal-Mart have also tagged their drugs.

Ron Moser of Wal-Mart said, "Right now, four suppliers are tagging pharmaceuticals at the package level, on over 20 SKUs. They are all using UHF tags. We have plans to expand item-level tagging beyond those 20 SKUs." Moser didn't say so, but others referred to the Wal-Mart participants as manufacturers of controlled substances.

The FDA, of course, is more concerned with the Pfizers of the world. Pfizer was represented at the workshop by Tom McPhillips, vice president, U.S. trade group. In an opening statement, he said, "It would be possible to implement RFID tagging for higher-risk products in three to five years. It would take several years beyond that before all drugs could get tags."

--By Stephen Barlas, Contributing Editor
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