WASHINGTON-The Food and Drug Administration has launched a new initiative to study the use of radio frequency identification technology to improve the safety and security of drugs, an effort with major implications for high-tech vendors and systems integrators that parallels plans of major retailers and manufacturers to integrate the wireless technology into supply-chain management in coming years.
The FDA published a Compliance Policy Guide for implementing RFID feasibility studies and pilot projects, actions intended to foster use of the technology in the U.S. drug supply chain by 2007.
“Radio frequency identification technology is an innovative response to the challenge of counterfeit drugs,” said Tommy Thompson, secretary of the Department of Health and Human Services. “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.”
The FDA also announced it is creating an internal workgroup whose charge is to monitor adoption of RFID in the pharmaceutical supply chain, identify regulatory issues raised by the use of this new technology and develop processes for handling those issues. FDA said it 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.
The “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.”
RFID is a state-of-the-art technology that uses electronic tags on product packaging to allow manufacturers and distributors to more precisely track drug products as they move through the supply chain. It is similar to the technology used for tollbooth and fuel-purchasing passes.
The FDA applauded efforts by pharmaceutical companies Pfizer, GlaxoSmithKline, and Purdue Pharma to leverage use of RFID technology
“We intend to work with industry and standard-setting organizations to explore the feasibility of allowing FDA to access relevant electronic pedigree information, as that information would greatly improve our ability to minimize exposure of consumers to counterfeit drugs by facilitating rapid criminal investigations of illicit transactions,” said Crawford.
Outside the pharmaceutical industry, top retailers-led by Wal-Mart-are championing RFID technology. RFID is also being employed for homeland security and defense applications as well as for livestock tracking.
