FDA urges trace technologies to secure drug supply chain

The Food and Drug Administration recommended today that drug makers and retailers use radio-frequency identification and other technologies to secure medications throughout the drug supply chain.

Although still rare in the United States, the FDA sees increasing efforts by well-organized counterfeiters employing sophisticated technologies and criminal operations to profit from drug counterfeiting. The report, Combating Counterfeit Drugs, is a product of the Counterfeit Drug Task Force that FDA Commissioner Mark McClellan formed in July 2003.

FDA intends to encourage the rapid development of 'track and trace' and product authentication technologies to be adopted by 2007. These technologies will provide an accurate drug 'pedigree,' a secure record documenting the drug was manufactured and distributed under safe and secure conditions. Paper record-keeping requirements are more likely to be incomplete or falsified, the FDA report said.

RFID tagging of products by manufacturers, wholesalers and retailers is the most promising approach to reliable product tracking and tracing. RFID will also reduce costs in inventory control while providing the ability to track and trace the movement of every package of drugs from production to dispensing, the report said.

'Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable,' the report said. FDA is working with product developers to ensure that its regulations promote the creation and application of this technology and with other government agencies to coordinate related activities.

Authentication technologies for pharmaceuticals, such as color shifting inks, holograms, fingerprints, taggants or chemical markers embedded in a drug or its label, are a critical component of protecting products against counterfeiting.

Because counterfeiters will adapt rapidly to any particular measure and because the most effective measures differ by product, the most effective use of authentication technology will vary by drug product over time.

FDA will also develop a system to help ensure effective reporting of counterfeit drugs to the agency and that strengthens FDA's rapid response to such reports. The agency will encourage health professionals to report suspected counterfeit drugs to FDA's MedWatch reporting system. FDA will also create a Counterfeit Alert Network to notify affected health professionals and the public whenever a counterfeit drug is identified.

The FDA can act to secure the U.S. drug supply, which it regulates, but not drugs purchased from other countries or from unregulated Internet sites that are not run by pharmacies licensed and regulated by U.S. states.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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