The US Food and Drug Administration (FDA) has stepped up its efforts to improve the safety and security of the nation's drug supply through the use of radio frequency identification (RFID) technology. FDA launched this effort by publishing a Compliance Policy Guide (CPG) for implementing RFID feasibility studies and pilot programmes that are designed to enhance the safety and security of the drug supply. This action continues FDA's commitment to promote the use of RFID by the US drug supply chain by 2007, FDA announced here.
In a related action, the FDA announced that it was creating an internal "RFID Workgroup" whose charge is to monitor adoption of RFID in the pharmaceutical supply chain, pro-actively identify regulatory issues raised by the use of this new technology, and develop straightforward processes for handling those issues. FDA believes that the workgroup will improve communication with members of the supply chain on RFID related issues and should facilitate both the performance of pilot studies and the collection of data needed to formulate policy.
RFID is a state-of-the-art technology that uses electronic tags on product packaging to allow manufacturers and distributors to more precisely keep track of drug products as they move through the supply chain. It is similar to the technology used for tollbooth and fuel purchasing passes.
RFID technology makes it easier to ensure that drugs are authentic, and it also creates an electronic pedigree, or record of the chain of custody, from the point of manufacture to the point of dispensing. Electronic pedigrees will improve patient safety and protect the public health by allowing wholesalers and retailers to rapidly identify, quarantine, and report suspected counterfeit drugs and conduct efficient, targeted recalls.
"Radio Frequency Identification technology is an innovative response to the challenge of counterfeit drugs," said Health and Human Secretary, Tommy G. Thompson. "It is our goal to insure that the drugs available in the United States are among the safest in the world. However, we still must continue to be on guard against those who would exploit patients by selling counterfeit drugs," Tommy added.
"These actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," said Dr. Lester M. Crawford, acting FDA commissioner. "This use of innovative technologies to protect the public health is exactly the type of bold leadership we expect to see more of in this arena. We hope that other manufacturers, wholesalers, and retailers will follow this example by also becoming early adopters of RFID," he added.
The FDA also applauded the initiatives announced by the pharmaceutical companies Pfizer, GlaxoSmithKline, and Purdue Pharma. Pfizer announced its plans to place RFID tags on all bottles of Viagra intended for sale in the United States as expeditiously as possible in 2005.
GlaxoSmithKline announced that it intends to begin using RFID tags in the next 12 to 18 months on at least one product deemed susceptible to counterfeiting. GSK's priority candidates for the tags are Retrovir, Combivir, Epivir, Trizivir, Ziagen and Zofran. The medicines are among those designated by the National Association of Boards of Pharmacies as being susceptible to adulteration, counterfeiting or diversion.
"GSK has developed a strategy across all business units to use this technology to protect patients as well as to improve accuracy and efficiency in our work," David Pulman, president of Global Manufacturing and Supply for GSK said in a release.
Purdue Pharma announced that it is placing RFID tags on bottles of OxyContin to make it easier to authenticate as well as track and trace this pain medication. FDA also acknowledged the leadership of Johnson & Johnson in establishing standards for RFID technology and participating in RFID pilot studies. Johnson & Johnson will continue to collaborate with industry partners to develop standards for ePedigree.