FDA proposes RFID tagging to stop drug counterfeiting

SAN FRANCISCO (02/20/2004) - A U.S. Food and Drug Administration (FDA) report, Combating Counterfeit Drugs, published this week recommends the "adoption and common use of reliable track and trace technology," later referred to as RFID (Radio Frequency ID), as the best way to protect the public from prescription drug counterfeiters.

Using RFID, a company could monitor the progress of shipments from the manufacturer to the wholesaler and through the retail distribution centers all the way to the individual pharmacies where the packages are eventually broken down and sold to consumers.

In laying out a roadmap for implementation of RFID on all drug shipments of pallets, cases, and packages in the U.S., the report estimated that the infrastructure should be well in place by 2007.

Among the benefits delineated by the FDA were using RFID tags to deter and detect counterfeit drugs, more easily and rapidly conduct recalls, manage inventory, and identify theft and diverted drug shipments -- all of which would lead to improved safety to consumers.

The FDA report also said that it will continue its stay of the adoption of the Prescription Drug Marketing Act (PDMA) as it relates to the pedigree of drugs, documents tracing sales of all drugs back to the manufacturer. The FDA cited the lower costs of using RFID.

"(It provides) a de facto electronic pedigree that could surpass the intent of the PDMA and lower costs," the report said.

While the report did not quantify the cost of rolling out an RFID infrastructure to accomplish these goals, the report did recognize that chief among the expenditures for the drug industry would be the purchase of additional hardware and software and the integration with legacy systems.

In addition, the FDA said there would be associated costs for compliance with regulatory requirements.

However, in order to reap the rewards of RFID tagging the FDA also notes that unless the entire industry participated in the effort the "full potential of RFID technology [would not be realized]."

Other unresolved issues recognized but not addressed with any specificity by the FDA include RFID standards and the need to look at issues around RFID database management such as "central versus distributive, ownership, access, and security."

Feasibility studies are currently underway by Wal-Mart Stores Inc., Accenture Ltd., and the CVS Corp. pharmacy chain store operation, according to the FDA.

On the deployment side, the FDA is recommending that the rollout start at the pallet and case level and move downstream to the package level, while at the same time concentrating on so-called high risk products with the incorporation of additional drugs over time.

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