Pharmaceutical Anti-Counterfeit RFID Package Supports FDA Mandate

Sun Microsystems and SupplyScape Offer Comprehensive RFID Package to Help Combat Drug Counterfeiting and Diversion

Integrated RFID Offering Safeguards Pharmaceutical Supply Chain

Santa Clara, CA, and Cambridge, MA, USA. February 19, 2004.

Sun Microsystems, Inc., and SupplyScape Corporation announced today a Pharmaceutical Anti-Counterfeit RFID Package, an offering enabling companies in the pharmaceutical supply chain to combat counterfeiting and diversion while gaining efficiencies throughout the supply chain. The offering addresses recommendations announced yesterday by the FDA Counterfeit Drug Task Force, as outlined in its "Combating Counterfeit Drugs" report at http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html.

According to the FDA report, "RFID technology will make the copying of medications either extremely difficult or unprofitable." Radio Frequency Identification (RFID) technology, coupled with the Electronic Product Code (EPC) and electronic pedigrees are key elements in a multi-layered approach to combat the growing problem of counterfeit drugs affecting patient safety in the United States. The SupplyScape on Sun offering supports the FDA and State government initiatives targeting counterfeit drugs by providing EPC-enabled RFID solutions for the pharmaceutical industry.

"Visionaries articulate a future in which RFID is ubiquitous and nearly everything is traceable," said Michael Swenson, research manager of Life Science Insights, an IDC subsidiary. "However, in this post Internet bubble era, broad visions of eventual pay-offs hold little appeal. It is vitally important that early RFID solutions deliver quick relief for pressing industry problems. Solutions must stand on their own merit and not rely on some future day in which RFID becomes pervasive. This Pharmaceutical Anti-Counterfeit solution appears to fit that profile."

The Pharmaceutical Anti-Counterfeit RFID package is based on Sun Java Enterprise System Software, an open and integrated software system, and Sun's RFID infrastructure software that features self-healing and provisioning and works with leading EPC-enabled readers, including Alien, AWID, Feig, Matrics, Tagsys and Tyco. Sun's EPC-compliant RFID software, combined with SupplyScape's electronic pedigree application, runs on low-cost Sun x86-based platform servers with the Solaris Operating System or Linux. Because all components adhere to the EPCglobal standards, pharmaceutical manufacturers, wholesale distributors, and pharmacies can quickly and cost-effectively add the solution to their current supply chain infrastructure and processes, helping streamline operations and secure the prescription drug delivery chain from counterfeits.

"The EPC-based Pharmaceutical Anti-Counterfeit package presented by SupplyScape and Sun highlights a novel and comprehensive way of addressing the issues of counterfeit drugs and product diversion," said Robin Koh, Director, MIT Auto-ID Labs. "They have worked with MIT's Auto-ID Labs, EPCglobal, Federal and State regulatory officials and the pharmaceutical industry to develop a complete solution that takes into account both regulatory and business requirements."

Using EPC Standards to Help Streamline Drug Delivery and Eliminate Counterfeits

SupplyScape Electronic Pedigree comes with the pedigree business rules for the Federal Prescription Drug Marketing Act (PDMA) as well as state pedigree regulations for Nevada and the Florida Pedigree Law. Customers enable the specific business rules they require for their business operations. The solution mass-serializes drug products and automates pedigrees for prescription drug track and trace and enables pharmaceutical manufacturers, wholesalers and pharmacies to increase the speed and quality of shipping and receiving, expedite returns processing and improve recall precision.

The FDA report cites: "Use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the U. S. drug supply. Mass serialization involves assigning a unique number (EPC) to each pallet, case, and package of drugs and then using that number to record information about all transactions involving the product, thus providing an electronic pedigree from the manufacturer to the point of dispensing. The EPC would allow each drug purchaser to immediately determine a drug's authenticity, where it was intended for sale, and whether it was previously dispensed."

"This comprehensive offering leverages RFID technology and the EPC Network to provide completely new track and trace capabilities for the pharmaceutical industry," says Liz From, Life Science Industry manager for Sun Microsystems. "The same technology offers short-term ROI by taking cost out of pharmaceutical supply chain operations."

"This is an integrated solution addressing a known problem — pharmaceutical counterfeiting and diversion," said Shabbir Dahod, President and CEO of SupplyScape. "Together with Sun, we are offering a specific bundled package ready to provide business value above and beyond what's needed to meet upcoming electronic pedigree regulations while safeguarding the drug supply and protecting brand value and integrity."

The SupplyScape on Sun solution is expected to be available in the second quarter of calendar year 2004. More information about Sun's leading role with RFID is available at http://www.sun.com/rfid.

About Sun Microsystems' Work With RFID

Sun Microsystems' industry-leading, standards-based, RFID solution is a comprehensive end-to-end offering that includes hardware, software, services and best-in-class partnerships. For over three years, Sun has been working to make RFID technology an extension of web services and a seamless part of software infrastructure such as the Sun Java Enterprise System. Sun has been a leading member of and advisor to the MIT Auto-ID Center — the driving force for Auto-ID standards, and has participated in numerous successful pilots and deployments. Sun is opening RFID Test Centers around the world to help companies test their RFID implementations before they invest — from tagging products, integrating data into back-end systems and sharing this data with supply chain partners. For more information on Sun's leading role with RFID visit http://www.sun.com/rfid. To start testing in a Sun RFID Test Center and learn how to get the competitive advantage necessary, email rfid-testcenter@sun.com today.

About SupplyScape

SupplyScape is a leader in applying the EPC and RFID standards in the pharmaceutical industry. The company is dedicated to helping pharmaceutical manufacturers, wholesalers, and pharmacies gain positive ROI on their technology investments to deliver safe drugs. SupplyScape provides an electronic pedigree solution that protects brand value and prevents counterfeit drugs in an open pharmaceutical supply chain. Additional information about SupplyScape is available at http://www.supplyscape.com.

About Sun Microsystems, Inc.

Since its inception in 1982, a singular vision — "The Network Is The Computer" — has propelled Sun Microsystems, Inc. (Nasdaq: SUNW) to its position as a leading provider of industrial-strength hardware, software and services that make the Net work. Sun can be found in more than 100 countries and on the World Wide Web at http://sun.com.

[Source: http://www.sun.com/smi/Press/sunflash/2004-02/sunflash.20040219.2.html]

References:

Combating Counterfeit Drugs. A Report of the Food and Drug Administration. February 2004. 54 pages. See also the PDF version.
SupplyScape web site. See also the announcement: "SupplyScape Announces RFID Software To Support FDA Initiative To Eliminate Counterfeit Drugs. New Electronic Pedigree Software Technology Helps Pharmaceutical Manufacturers, Wholesalers and Pharmacies Track Prescription Drugs."
Sun RFID Resources. Auto-ID: Reinventing the Global Supply Chain.
"Radio Frequency Identification (RFID) Resources and Readings"
"Physical Markup Language (PML) for Radio Frequency Identification (RFID)"

Prepared by Robin Cover for The XML Cover Pages archive.

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Sun Microsystems, Inc., and SupplyScape Corporation announced today a Pharmaceutical Anti-Counterfeit RFID Package, an offering enabling companies in the pharmaceutical supply chain to combat counterfeiting and diversion while gaining efficiencies throughout the supply chain. The offering addresses recommendations announced yesterday by the FDA Counterfeit Drug Task Force, as outlined in its "Combating Counterfeit Drugs" report at http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html. According to the FDA report, "RFID technology will make the copying of medications either extremely difficult or unprofitable." Radio Frequency Identification (RFID) technology, coupled with the Electronic Product Code (EPC) and electronic pedigrees are key elements in a multi-layered approach to combat the growing problem of counterfeit drugs affecting patient safety in the United States. The SupplyScape on Sun offering supports the FDA and State government initiatives targeting counterfeit drugs by providing EPC-enabled RFID solutions for the pharmaceutical industry. "Visionaries articulate a future in which RFID is ubiquitous and nearly everything is traceable," said Michael Swenson, research manager of Life Science Insights, an IDC subsidiary. "However, in this post Internet bubble era, broad visions of eventual pay-offs hold little appeal. It is vitally important that early RFID solutions deliver quick relief for pressing industry problems. Solutions must stand on their own merit and not rely on some future day in which RFID becomes pervasive. This Pharmaceutical Anti-Counterfeit solution appears to fit that profile." The Pharmaceutical Anti-Counterfeit RFID package is based on Sun Java Enterprise System Software, an open and integrated software system, and Sun's RFID infrastructure software that features self-healing and provisioning and works with leading EPC-enabled readers, including Alien, AWID, Feig, Matrics, Tagsys and Tyco. Sun's EPC-compliant RFID software, combined with SupplyScape's electronic pedigree application, runs on low-cost Sun x86-based platform servers with the Solaris Operating System or Linux. Because all components adhere to the EPCglobal standards, pharmaceutical manufacturers, wholesale distributors, and pharmacies can quickly and cost-effectively add the solution to their current supply chain infrastructure and processes, helping streamline operations and secure the prescription drug delivery chain from counterfeits. "The EPC-based Pharmaceutical Anti-Counterfeit package presented by SupplyScape and Sun highlights a novel and comprehensive way of addressing the issues of counterfeit drugs and product diversion," said Robin Koh, Director, MIT Auto-ID Labs. "They have worked with MIT's Auto-ID Labs, EPCglobal, Federal and State regulatory officials and the pharmaceutical industry to develop a complete solution that takes into account both regulatory and business requirements." Using EPC Standards to Help Streamline Drug Delivery and Eliminate Counterfeits SupplyScape Electronic Pedigree comes with the pedigree business rules for the Federal Prescription Drug Marketing Act (PDMA) as well as state pedigree regulations for Nevada and the Florida Pedigree Law. Customers enable the specific business rules they require for their business operations. The solution mass-serializes drug products and automates pedigrees for prescription drug track and trace and enables pharmaceutical manufacturers, wholesalers and pharmacies to increase the speed and quality of shipping and receiving, expedite returns processing and improve recall precision. The FDA report cites: "Use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the U. S. drug supply. Mass serialization involves assigning a unique number (EPC) to each pallet, case, and package of drugs and then using that number to record information about all transactions involving the product, thus providing an electronic pedigree from the manufacturer to the point of dispensing. The EPC would allow each drug purchaser to immediately determine a drug's authenticity, where it was intended for sale, and whether it was previously dispensed." "This comprehensive offering leverages RFID technology and the EPC Network to provide completely new track and trace capabilities for the pharmaceutical industry," says Liz From, Life Science Industry manager for Sun Microsystems. "The same technology offers short-term ROI by taking cost out of pharmaceutical supply chain operations." "This is an integrated solution addressing a known problem — pharmaceutical counterfeiting and diversion," said Shabbir Dahod, President and CEO of SupplyScape. "Together with Sun, we are offering a specific bundled package ready to provide business value above and beyond what's needed to meet upcoming electronic pedigree regulations while safeguarding the drug supply and protecting brand value and integrity." The SupplyScape on Sun solution is expected to be available in the second quarter of calendar year 2004. More information about Sun's leading role with RFID is available at http://www.sun.com/rfid. About Sun Microsystems' Work With RFID Sun Microsystems' industry-leading, standards-based, RFID solution is a comprehensive end-to-end offering that includes hardware, software, services and best-in-class partnerships. For over three years, Sun has been working to make RFID technology an extension of web services and a seamless part of software infrastructure such as the Sun Java Enterprise System. Sun has been a leading member of and advisor to the MIT Auto-ID Center — the driving force for Auto-ID standards, and has participated in numerous successful pilots and deployments. Sun is opening RFID Test Centers around the world to help companies test their RFID implementations before they invest — from tagging products, integrating data into back-end systems and sharing this data with supply chain partners. For more information on Sun's leading role with RFID visit http://www.sun.com/rfid. To start testing in a Sun RFID Test Center and learn how to get the competitive advantage necessary, email rfid-testcenter@sun.com today. About SupplyScape SupplyScape is a leader in applying the EPC and RFID standards in the pharmaceutical industry. The company is dedicated to helping pharmaceutical manufacturers, wholesalers, and pharmacies gain positive ROI on their technology investments to deliver safe drugs. SupplyScape provides an electronic pedigree solution that protects brand value and prevents counterfeit drugs in an open pharmaceutical supply chain. Additional information about SupplyScape is available at http://www.supplyscape.com. About Sun Microsystems, Inc. Since its inception in 1982, a singular vision — "The Network Is The Computer" — has propelled Sun Microsystems, Inc. (Nasdaq: SUNW) to its position as a leading provider of industrial-strength hardware, software and services that make the Net work. Sun can be found in more than 100 countries and on the World Wide Web at http://sun.com. [Source: http://www.sun.com/smi/Press/sunflash/2004-02/sunflash.20040219.2.html] References: Combating Counterfeit Drugs. A Report of the Food and Drug Administration. February 2004. 54 pages. See also the PDF version. SupplyScape web site. See also the announcement: "SupplyScape Announces RFID Software To Support FDA Initiative To Eliminate Counterfeit Drugs. New Electronic Pedigree Software Technology Helps Pharmaceutical Manufacturers, Wholesalers and Pharmacies Track Prescription Drugs." Sun RFID Resources. Auto-ID: Reinventing the Global Supply Chain. "Radio Frequency Identification (RFID) Resources and Readings" "Physical Markup Language (PML) for Radio Frequency Identification (RFID)" Prepared by Robin Cover for The XML Cover Pages archive.