Concerned about counterfeiting, FDA publishes compliance guide for RFID feasibility studies, pilot programs - Continuing its efforts to promote the use of radiofrequency identification (RFID) technology in the drug-supply chain by 2007, Lester M. Crawford, DVM, PhD, acting FDA commissioner, today announced a number of agency actions designed to speed up development and implementation of feasibility studies and pilot programs using the technology.
RFID is a state-of-the-art technology that uses electronic tags on product packaging to allow manufacturers and distributors to track drug products, helping protect the products from diversion, theft, and counterfeiting. RFID is similar to the technology used for tollbooth and fuel-purchasing passes, and it is being pushed aggressively for consumer goods by major retailers such as Wal-Mart. Each RFID chip contains electronic data about the product that are not accessible or subject to tampering. The technology will allow tracking of wholesale drug products from manufacturer to pharmacy; it is expected to eventually replace paper pedigrees now required. FDA hopes to encourage drug companies to take part in a testing phase for RFID technology that will continue until December 31, 2007. FDA's actions are part of the implementation of goals outlined in the February 2004 Task Force Report, “Combating Counterfeit Drugs.”
Crawford, speaking during a news conference today, said FDA is issuing a Compliance Policy Guide in answer to drug companies' questions regarding use of RFID technology and their concerns about labeling requirements. Companies can use the guide in implementing RFID feasibility studies and pilot programs. The guide takes effect immediately upon its publication in the Federal Register, but FDA is accepting comments that will be considered in future revisions.
FDA is also establishing an internal workgroup to monitor adoption of RFID in the pharmaceutical supply chain, proactively identify regulatory issues raised by the use of this new technology, and develop straightforward processes for handling those issues.
Some companies already are moving toward the use RFID technology in drug production: Pfizer in the making of Viagra, Purdue Pharma with Oxycontin and eventually Palladone, and GlaxoSmithKine with at least one of its products susceptible to counterfeiting.
With this encouragement, FDA hopes the RFID technology will be in widespread use by 2007. Crawford emphasized that the U.S. drug supply is very safe but FDA is “determined to protect the public” from increasing threats of counterfeiting, theft, and diversion of drugs.
FDA believes that the new technology will eventually lower the cost of tracking, inventory, and delivery and eventually reduce costs associated with inventory tracking and similar functions. FDA acknowledged Johnson & Johnson for working to establish standards in this area.
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