St. Louis News
DateBar Vol 9 2004
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Electronic Product Codes to Be Used
to Fight Counterfeit Drugs

ST. LOUIS, (PRNewswire), November 16, 2004 - The Food and Drug Administration (FDA) has 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.

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.


Archived Stories:
Chiron Will Not Supply Flu Vaccine for Upcoming Influenza Season
Merck Announces Voluntary Worldwide Withdrawal of VIOXX®
Classroom Triggers for Asthma and Allergies
Obesity is Not a Disease
Memory Study Gives New Hope in the Fight Against Alzheimer's
Eating Apples and Drinking Apple Juice Today May Protect Brain Health Tomorrow
Chamber Study Shows Obesity Lawsuits Are No Diet Aid
Summer Season Sizzles With Potential for Injuries Around the Home

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