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FDA Issues New 'Counterfeit Drug Task Force' Report
The agency will not mandate RFID's use within the pharmaceutical industry, but urges the industry to 'move quickly to implement this technology.'
Jun 09, 2006—The U.S. Food and Drug Administration (FDA) issued today its much-anticipated report on RFID's use in the pharmaceutical industry, calling RFID "the most promising technology for implementing electronic track and trace in the drug supply chain." For several years, the agency has advocated the use of RFID tagging at the item, case and pallet levels to track and trace pharmaceuticals as a means of fighting counterfeit drugs.
The report, "FDA Counterfeit Drug Task Force Report: 2006 Update," does not mandate RFID's use within the pharmaceutical industry. However, it does recommend that the industry "move quickly to implement this technology."
The Task Force consists of senior staff from the agency's Office of the Commissioner (Office of Policy and Planning, Office of the Chief Counsel), the Office of Regulatory Affairs, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. For more than two years, the agency's Counterfeit Drug Task Force has been investigating RFID technology and the concept of an electronic pedigree (e-pedigree), a procedure that records where a drug is manufactured and how it is distributed. In early 2004, the FDA had hoped that by 2006, the pharmaceutical supply chain would be using RFID tags at the individual item level for all drugs likely to be counterfeited, and be able to tag all drugs at the pallet, case and unit levels the following year (see FDA Endorses RFID Technology).
At a public workshop last February, acting FDA Commissioner Andrew von Eschenbach requested that the agency's Counterfeit Drug Task Force file a new report by May 2006. The purpose of that report, issued today, is to provide recommendations on how the agency should move forward to make the pharmaceutical supply chain more secure (see FDA to Update Its RFID Vision).
In the report, the task force did not determine whether an RFID tag should be encoded with a drug's National Drug Code (NDC). The NDC is a product identifier, and some parties have expressed concern that if NDCs were encoded onto RFID tags, the practice could jeopardize the privacy of patients and potentially endanger the drug supply chain. Consequently, the FDA has stipulated that should any company opt to record the NDC on the RFID tag, it should also encrypt the NDC.
That requirement is likely to sway companies away from encoding tags with the NDCs, according to Paul Chang, IBM's associate partner of business consulting services. Chang, who has spent some time advising the FDA on the opportunity and capabilities of RFID, explains that adding any encrypted data to an RFID tag will likely increase the cost of the tag and slow down processing speeds.
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