I recently received a press release originating from the town of La Penne sur Huveaune, France. The purpose was to announce a contract between pharmaceutical giant Pfizer and the French RFID technology firm TAGSYS. These two companies are implementing technology to protect the pharmaceutical supply chain from counterfeit and black-market drugs. The launch product for the technology is Pfizer's much-counterfeited Viagra.
As this is likely to be the most high-profile use this year of RFID in the pharmaceutical supply chain, I thought it would be useful to review the issues and regulatory background surrounding this announcement.
Background On FDA Policy
The organization that is responsible for regulating pharmaceutical safety in the U.S. is, of course, the Food and Drug Administration (FDA). Since the US is such a huge pharmaceutical market, FDA policy has a world-wide effect on manufacturers. The story of the French RFID tags on Viagra therefore begins with a 1988 set of FDA regulations enacted following the passage of the Prescription Drug Marketing Act (PDMA) of 1987.
The PDMA was written to address the problems of drug counterfeiting in the pharmaceutical supply chain. Pharmaceuticals pass through many different points in the distribution chain from the factory to your local pharmacist. This leaves the system vulnerable to the introduction of counterfeit drugs. For this reason, the PDMA requires verification of the source of pharmaceutical shipments. The method of accounting for where a pharmaceutical comes from and verifying it to be legitimate is called the "chain of custody." It has been largely paper-based for many years.
The FDA has been investigating the use of information technology to make the chain of custody less labor-intensive and more secure. They issued a report in February 2004 that discussed various ways of automating the chain-of-custody "pedigree" of a drug. This report, "Combating Counterfeit Drugs - A Report of The Food and Drug Administration," was the first to propose the use of RFID tags to create a secure "e-pedigree" that could be physically tied to each pharmaceutical unit of sale (box, bottle, blister pack, case, or pallet). At the time of this report, the FDA anticipated that the e-pedigree would be achievable by 2007. The technology and information standards have not kept pace with anticipated progress, however, so the FDA is looking at revising the date of implementation beyond 2007.
System Features
The TAGSYS system for Viagra will be the first deployment by Pfizer of RFID technology at the item-level across an entire product line. As such, it represents a significant step towards achieving the goals of the e-pedigree concept.
The system begins by integrating RFID tag encoders and applicators into Pfizer's production infrastructure. It seems likely that some of the RFID tags will be integrated into the pharmaceutical packaging, rather than being stick-on labels. The system includes tag-level security designed to protect the information encoded on the tag.
Special tag readers will be provided at points in Pfizer's distribution chain. The use of these readers, coupled with TAGSYS-provided software, will allow the authenticity of Viagra shipments to be controlled throughout the distribution chain. A unique feature of the system is the proposal to allow end-users to use HF RFID at an item-level to authenticate all Viagra sold in the United States.
Conclusion
We have seen a great deal of news in the past two years regarding the use of RFID in consumer goods and the retail supply chain. The Pfizer/TAGSYS initiative is an important step towards the use of a common e-pedigree for pharmaceuticals. Due to the nature of the Viagra product, the effort is sure to generate a good deal of press. It may well be that 2006 will become known as "The year of RFID" in the pharmaceutical industry.
Paul Faber is a principal with Raleigh, N.C.-based Tompkins Associates, a supply-chain-solutions consulting firm. As the chief manager of RFID equipment implementation at Tompkins Emerging Technology Center, Paul possesses extensive experience in material handling solutions, systems integration, and installation. He has managed field integration and operations activities at material handling sites around the world.
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