Drug Radio Frequency ID To Be Widespread By 2007, FDA's McClellan Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA expects the anticounterfeit technology will be implemented over a phased-in timeline. Although the agency does not plan to require use, it will take an active role in facilitating adoption of RFID.
|
FDA expects radio frequency identification to be the standard track and trace technology for pharmaceutical products by 2007. "Based on our analysis, we believe that widespread, reliable tracking technologies should be available by 2007," FDA Commissioner McClellan said during a Feb. 18 press conference announcing the agency's final 1 report on "Combating Counterfeit Drugs." The agency is predicting that some pallets, cases and packages of pharmaceuticals at high risk of being counterfeited will be serialized with RFID tags by the end of 2005. Using RFID for high-risk drugs first makes the most sense financially, McClellan said. "In 2004, it's still not cheap enough to be used universally in products, but I think companies are looking closely at whether the additional costs of these technologies, which can be well under a dollar per RFID unit, are worthwhile for some of their riskiest products," the commissioner said. While FDA will not require implementation of RFID technology, it expects most high-risk drugs will have RFID incorporated at the pallet, case and packages level by 2006. By the end of 2007, FDA expects serial identification of all pallets and cases of pharmaceuticals and the serialization of most drug packages. An interim counterfeit drug report also discussed the potential for RFID to provide pharmaceuticals with an electronic pedigree. FDA's counterfeit drug task force solicited public comments on the interim report, including 2 comments from the Healthcare Distribution Management Association supporting a phase-in of RFID technology. Lilly has already initiated pilot programs to explore the use of RFID as part of a multi-pronged anticounterfeit strategy. The agency "intends to regularly review the pace at which RFID is being adopted in the U.S. drug distribution system," the final report says. Concerning the safety of this technology, McClellan said "in many cases, particularly for solid, small-molecule drugs, we've got a very high level of confidence" in the safety of RFID. The agency plans to take steps to facilitate the adoption of RFID technology. "FDA plans to propose or clarify, as necessary and appropriate, policies and regulatory requirements related to the use of RFID. Labeling, electronic records, product quality, and Current Good Manufacturing Practices requirements are issues that have arisen in connection with RFID," the report states. "However, regulatory or policy determinations regarding these, or other, issues should not be made until they can be informed by sufficient data and significant marketplace experience." - John Rancourt |