WASHINGTON, DC (November 15, 2004) – The Food & Drug Administration (FDA) today 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 the effort by publishing a Compliance Policy Guide (CPG) for implementing RFID feasibility studies and pilot programs that are designed to enhance the safety and security of the drug supply. The FDA said its action continues the agency’s “commitment to promote the use of RFID by the U.S. drug supply chain by 2007.”
In a related action, the FDA announced that it is 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 the new technology, and develop straightforward 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.”
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.
The FDA applauded 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.
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 the pain medication. Based on the availability of sufficient RFID tags, Purdue also plans to tag bottles of Palladone, a newly approved product to treat persistent, moderate to severe pain. Oxycontin, which is a controlled substance, has been subject to abuse as well as theft and diversion, the FDA said.
The agency also acknowledged the leadership of Johnson & Johnson in establishingstandards for RFID technology and participating in RFID pilot studies. Johnson & Johnson is expected to continue to collaborate with industry partners to develop standards for ePedigree.
“Radio Frequency Identification technology is an innovative response tothe challenge of counterfeit drugs,” Health and Human Services Secretary TommyG. Thompson said. “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.”
Today’s actions were designed to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer to the pharmacy, according to Dr. Lester M. Crawford, acting FDA commissioner.
RFID technology makes it easier to ensure that drugs are authentic, and creates an electronic pedigree – or record of the chain of custody – from the point of manufacture to the point of dispensing. It is hoped 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.
The FDA said it considers electronic pedigrees to be a type of “electronic safety net” which utilizes technology that allows illicit drug transactions to be rapidly identified and, potentially, transmitted to the FDA thereby improving the agency’s ability to conduct investigations of suspected counterfeiting or diversion of prescription drugs.
Today’s actions were regarded as key steps in implementing a major recommendation of the agency’s report issued February 18 titled, “Combating Counterfeit Drugs.” The report recommended that RFID technology be in widespread use throughout the pharmaceutical industry by 2007.
Although the pharmaceutical industry has taken several steps to test RFID technology, the FDA believes that its latest actions will provide a stimulus for further activity in the next year. For example, the FDA said it expects that RFID standard-setting activities and applied research in such areas as tag numbering, optimal frequency use, and database management will be accelerated.
The FDA said it believes its CPG will clear the way for more pilot programs thatinvolve RFID tagging of all packages of certain products, especially those that are highly likely to be counterfeited. The agency hopes that more firms will use RFID technology to gain experience with transferring, storing, and securing the data that RFID provides.
The scope of the CPG is based on information that the FDA obtained concerningongoing and planned RFID feasibility studies examining use of RFID technology for various business purposes including inventory control, and tracking and tracing of drugs.
The CPG will go into effect immediately upon publication in the Federal Register, the FDA said. The agency said it will consider public comments in any revision of the CPG.
Those interested in commenting on the CPG may submit their comments to:www.fda.gov/dockets/ecomments.
