FDA's RFID Plan Criticized
In a recent article entitled "Drug Supply Security Expert Points to Weakness in RFID" (FDA Week - www.InsideHealthPolicy.com - June 9, 2006), the Institute of Health Law Studies Executive Director Bryan Liang warns that the FDA "should not rely on" RFID technology to stop the counterfeiting of prescription drugs, which has risen sharply in the past few years. Liang argues that using RFID chips on the packaging of pharmaceuticals will not stop the counterfeiting because drugs are removed from their original packaging and repackaged into smaller quantities for retail sale, and therefore any protection provided by the RFID chip is lost at that point.
"Repackaging defeats everything the manufacturer does to combat counterfeiting," according to Alan Goldhammer of The Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA agrees with Liang, and has expressed these concerns as far back as 2003, when they noted in a letter to the FDA that, "the FDA should look for opportunities to reduce the level of repackaging for resale which exists today." PhRMA does not discount the advantages of using RFID for drug security, but warns that it alone is not sufficient.
Liang suggests additional ways to fight drug counterfeiting, including the use of an online reporting system so that patients can easily report when they suspect that their drugs are counterfeits. The FDA's current database, MedWatch, is said to be very difficult to navigate. Liang also suggests more international support for the issue through information sharing, and stricter penalties for those caught in drug counterfeiting schemes.
Liang and PhRMA are on the right track-- RFID use alone is not sufficient to totally curb drug counterfeiting, but it can be helpful if done correctly. The proposed e-pedigree for tracking the movement of a drug through the supply will be effective for its purpose, and that's worth something.