Just as there is no "silver-bullet," according to experts, when it comes to selecting the perfect authentication technology to deter consumer-product counterfeiting, a recent report issued by the U.S. Food & Drug Administration's (www.fda.gov) Counterfeit Drug Task Force indicates that there is no single solution—legal, technological, educational, etc.—that can, or should, be employed to protect the U.S. drug supply from counterfeiting. As the agency reports in "Combating Counterfeit Drugs, A Report of the Food and Drug Administration," the task force's interaction with a number of groups affected by the issue "reinforced the need for FDA and others to take action in multiple areas to create a comprehensive system of modern protections against counterfeit drugs."
Nonetheless, if one strategy can be said to be the keystone of FDA's recommendations, it's mass-serialization, which the report claims is "the single most powerful tool available to secure the U. S. drug supply."
The report continues: "Mass serialization involves assigning a unique number (the Electronic Product Code, or EPC) to each pallet, case and package of drugs and then using that number to record information about all transactions involving the product, thus providing an electronic pedigree from the point of manufacture to the point of dispensing. This unique number would allow each drug purchaser to immediately determine a drug's authenticity, where it was intended for sale, and whether it was previously dispensed."
RFID 'most promising'
In the report, FDA concludes that the "most promising" technology for implementing mass-serialization is radio frequency identification (RFID). However, as Paul M. Rudolf, MD, JD, senior advisor for medical and health policy at FDA told attendees at Pira's Brand Protection USA conference in March, one of the limiting factors to widespread use of RFID right now is the expense of the technology. Rudolf estimates the current cost of a passive tag to be 25 to 30 cents/tag, but says he believes that number may decrease to 5 to 10 cents/tag as volumes increase. "Because Wal-Mart and the Department of Defense are mandating the use of RFID tags, they will begin to be mass-produced," he says.
"The investment in the infrastructure will be large," he adds, "but the benefits to business will outweigh those costs." Besides RFID's ability to authenticate product quickly, the technology provides other advantages, Rudolf says. These include the ability to conduct efficient targeted recalls, to deter and detect counterfeit drugs, to conduct efficient, targeted recalls, to manage inventory, to identify theft and diverted drugs, and to improve patient safety by assuring correct dispensing of drugs.
But FDA's report noted that there are several important unresolved issues accompanying the use of RFID in the pharmaceutical arena. These include the need to develop standards and business rules for RFID; the need to address database management issues; and the need to determine the effect of RFID on product quality.
Lacking sufficient experience with the implementation of RFID in the pharmaceutical supply chain from which to draw conclusions, FDA says in the report that it cannot yet initiate policies or requirements for the use of the technology.
In the interim, FDA says it will facilitate and learn from the feasibility studies underway at various sites, such as at Wal-Mart, where drug manufacturers and wholesalers will attach RFID tags to all bottles of controlled substances, and at CVS, where the potential benefits that tagging and tracing pharmaceuticals and prescriptions in a retail pharmacy would have on operating efficiency, quality of patient care and customer service are being studied.
Despite its enthusiasm for RFID," FDA recognizes that different migratory paths to the implementation of track-and-trace mass-serialization will be necessary to accommodate the varying needs of industry members and their position within the supply chain. One transition technology cited by FDA is 2D bar coding. However, FDA states there is a "need for all stakeholders to embrace the technology in similar timeframes in order to realize the full potential of RFID technology."
In its report, the agency suggests business steps that industry members interested in implementing RFID can take, as well as a list of those issues that must be resolved surrounding industry standards. FDA also presents a timeline for the adoption of RFID, from the present through December 2007, at which time they say it is feasible to expect mass serialization of all pallets and cases of pharmaceuticals; mass serialization of most packages of pharmaceuticals; and the acquisition and use of RFID technology by all manufacturers, all wholesalers, all chain drugstores, all hospitals and most small retailers.