Radio ID Tags For US Drugs
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
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."
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