DOCTOR'S VIEW ARCHIVE

Medical Authors and Editors: Barbara K. Hecht, Ph.D. and Frederick Hecht, M.D.

November 15, 2004 -- The Food and Drug Administration and major drug makers are expected to announce today that they will put tiny radio antennas on the labels of millions of medicine bottles to combat counterfeiting, according to Gardiner Harris writing in The New York Times today. The tagged medicine bottles will, at first, be only the large ones from which druggists get the pills to fill prescriptions but experts do not expect the technology to stop there.

Perspective

Although The New York Times has this story today on the front page, it is not really a new story. Last February the FDA called for the voluntary use of radio frequency identification (RFID) systems by drugmakers and distributors by 2007.

The FDA has repeatedly reported that there has been an increase in drug counterfeiting over the past several years. Counterfeit drugs can harm consumers. And they clearly cut into the profits of drug companies.

RFID Tags

RFID technology is also not new. It was used in World War II by the British to distinguish their returning planes from incoming German ones. The British planes were outfitted with an early version of an RFID tag.

An RFID tag is a device for remotely storing and retrieving data. The tag may be a little sticker that can be attached to a medicine bottle (or airplane). The tag contains an antenna that enables it to receive and respond to a radiofrequency "query" from an RFID device called a transceiver.

Most RFID tags do not have their own power supply. The radiofrequency query induces a tiny electrical current in the antenna, permitting the tag to send a brief response, usually just an ID number.

Such RFID tags are quite small. The smallest tags that are now commercially available measure 0.4 × 0.4 mm and are thinner than a sheet of paper. They start at about $0.40 (40 cents) a tag.

Tag on Viagra

By outfitting drug packages with RFID tags, companies could trace the path the drugs take from the time they are produced to the moment they are dispensed, according to a FDA report in February.

Among the medicines that will get an RFID tag is Viagra (sildenafil). The drug for erectile dysfunction (impotence ED) is one of the most widely counterfeited drugs in the world.

Related MedicineNet Links

sildenafil (Viagra)
Buying Medicine and Medical Products Online (Health Fact)
Medications Center

The following is excerpted from press release P04-103 issued by the FDA on November 15, 2004:

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

The Food and 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 this 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. This action continues FDA's commitment to promote the use of RFID by the U.S. drug supply chain by 2007.

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.

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.