Privacy groups question RFID use in medicine tracking

The FDA says it won't trace which drugs consumer use

As the U.S. Food and Drug Administration considers the use of radio frequency identification tags to help fight counterfeit prescription drugs, privacy advocates are cautiously watching to be sure consumer privacy isn't lost in the process.

Last year, the FDA called for the widespread use of RFID tags to help ensure that drugs sold to consumers are legitimate. Under the FDA proposal, RFID tags would be used on cartons and pallets of drugs throughout the pharmaceutical supply chain by 2007.

The problem, according to privacy advocates , is that the FDA is considering more than just tracking large shipping containers or crates of medicines with RFID tags; it could also use the tags to track individual medicine bottles or even individual tablets. That, privacy advocates said, would be invasive.

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As the U.S. Food and Drug Administration considers the use of radio frequency identification tags to help fight counterfeit prescription drugs, privacy advocates are cautiously watching to be sure consumer privacy isn't lost in the process.

Last year, the FDA called for the widespread use of RFID tags to help ensure that drugs sold to consumers are legitimate. Under the FDA proposal, RFID tags would be used on cartons and pallets of drugs throughout the pharmaceutical supply chain by 2007.

The problem, according to privacy advocates , is that the FDA is considering more than just tracking large shipping containers or crates of medicines with RFID tags; it could also use the tags to track individual medicine bottles or even individual tablets. That, privacy advocates said, would be invasive.

Dr. Scott Gottlieb, deputy commissioner of medical and scientific affairs at the FDA, said the agency has talked with pharmaceutical companies, retailers, scientists and others for the past several years to ensure that consumers get legitimate drugs when their prescriptions are filled. Today's "track and trace" methods use paper records to follow drug shipments from manufacturers to wholesalers and retail stores.

But paper records are not foolproof, Gottlieb said. By moving to electronic methods, including the use of RFID, the drug distribution system could be made safer against counterfeiting, he said.

"We think RFID is the most promising and achievable means to get to electronic track and trace or electronic pedigree by 2007," Gottlieb said. An "electronic pedigree" is a record of custody for a drug, which would include all transactions from its place of manufacture to where it is shipped, stored and sold. The FDA has been looking at RFID and other electronic technologies for the past three years, with a goal of having procedures in place by 2007.

In addition to using RFID, the FDA has eyed the use of special inks on individual pills or holographic images on medicine bottles, he said. "We've always said that we don't think there's a single magic bullet" to solve the problems and that several techniques will be needed to fight counterfeiting, Gottlieb said.

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