FDA Announces New Initiative To Protect The U.S. Drug Supply Through The Use Of Radiofrequency Identification Technology

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 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.

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.

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. 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. 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.

"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."

"Today's 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 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.

FDA 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 FDA's ability to conduct investigations of suspected counterfeiting or diversion of prescription drugs.

"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," Dr. Crawford added.

Today's actions are key steps in implementing a major recommendation of FDA's report, issued February 18, 2004, 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 other important steps to test RFID technology, FDA believes that the actions announced today will provide a stimulus for even further activity in the next year. For example, FDA expects that RFID standard-setting activities and applied research in such areas as tag numbering, optimal frequency use, and database management will be accelerated.

FDA believes the CPG will clear the way for more pilot programs that involve RFID tagging of all packages of certain products, especially those that are highly likely to be counterfeited. FDA hopes that more firms will take this opportunity to 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 FDA obtained concerning ongoing and planned RFID feasibility studies examining use of this technology for various business purposes including inventory control, and tracking and tracing of drugs.

To encourage these studies, the CPG announces FDA's intention to exercise enforcement discretion if studies falling within the parameters of the CPG trigger certain regulatory requirements.

Because of the importance of beginning RFID feasibility studies as quickly as possible, this CPG will go into effect immediately upon publication in the Federal Register. FDA will consider all public comments in any revision of the CPG.

Those interested in commenting on the CPG may submit their comments to: http://www.fda.gov/dockets/ecomments/