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FDA to Update Its RFID Vision

At an FDA-organized meeting, drugmakers, pharma distributors and technology providers discussed the challenges ahead in using RFID to make the drug supply chain safer.
By Mary Catherine O'Connor
Feb 10, 2006Two years ago, the U.S. Food and Drug Administration (FDA) endorsed the use of RFID technology, along with other technologies, to help track and trace pharmaceuticals—securely and accuratelyfrom manufacturer to distributor to retailer—as a means of fighting the growth of counterfeit drugs. Though it hadn’t issued a mandate, the FDA had hoped that by 2006, tagging would be at the individual unit level for all drugs likely to be counterfeited, with all drugs being tagged at the pallet, case and unit levels a year later (see FDA Endorses RFID Technology.)

Activity among drugmakers toward meeting those goals—or, more accurately, the lack thereof—prompted the FDA to pull together several hundred regulators, pharmaceutical companies, wholesalers, retail and small independent pharmacies, industry associations and technology providers to discuss this issue. The FDA Anti-Counterfeit Drug Initiative Public Workshop, a two-day event held this week in Bethesda, Md., was created to identify the hurdles that have caused the slower-than-expected movement toward widespread RFID use, and to determine what must be done to accelerate testing and deployment of the technology.

At the meeting, acting FDA Commissioner Andrew von Eschenbach asked the FDA's Counterfeit Drug Task Force to file a new report to the FDA by May 2006, containing recommendations on how the agency should move forward to make the pharmaceutical supply chain more secure. Among the questions posed: Should it require drug sellers to use an electronic pedigree, a secure record documenting that the drug was manufactured and distributed under safe and secure conditions? And should any e-pedigree requirements also include a mandate to identify each bottle with a serial number encoded to an RFID tag?

The meeting was held Feb 8 and 9. A number of drugmakers, including Pfizer and Johnson & Johnson, presented summaries of their efforts to test RFID and e-pedigrees. Representatives from several industry associations, among them the National Association of Boards of Pharmacy (NABP), the Pharmaceutical Research and Manufacturers Association (PHRMA) and the Healthcare Distribution Management Association (HDMA), provided their perspectives. Carmen Catizone, the NABP's executive director, stressed that the FDA's 2004 recommendations for the widespread use of RFID in track-and-trace deployments can and should be realized.

To date, however, Purdue Pharma is the only pharmaceutical manufacturer to announce publicly an electronic pedigree pilot involving RFID (see Purdue Pharma to Run Pedigree Pilot). Pfizer is using RFID to track bottles of Viagra as an anticounterfeiting measure (see Pfizer Using RFID to Fight Fake Viagra), but is not yet including item serialization as part of an e-pedigree system.

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