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E-Pedigree's Evolution
Recent legislative initiatives, technological advances and the financial benefits of electronic pedigrees have engendered a new willingness by pharmaceutical companies to utilize RFID in their battles against counterfeit drugs.
March 5, 2007—Much has been written about the implementation delays of the Food and Drug Administration's (FDA) electronic pedigree (e-pedigree) program. More than three years after the FDA proposed a universal RFID-based e-pedigree, fewer than 10 types of prescription drugs are currently being tagged upon entering the supply chain. Factors attributed to this inauspicious initiation include costs, privacy and legal matters, and a lack of technical standards. The tide may soon turn, however, as recent legislative initiatives, technological advances and the industry's realization of the financial benefits of e-pedigrees have all resulted in a new willingness by drug companies to utilize RFID in their battles against faux pharmaceuticals.
In 2003, the FDA released a report recommending that pharmaceutical companies use RFID to create e-pedigrees for tracking prescription drugs as they are distributed into commerce. With a unit of drugs tagged at the manufacturer, and with RFID interrogators tracking that unit through the supply chain to the pharmacy, the authenticity of the product could be assured. Soon thereafter, the organization implemented pilot programs and publicly declared that by 2007, it would like to see U.S. drug companies implement RFID to track all prescription drugs at the unit level.
Still, in spite of the FDA's recommendation, drug companies were initially hesitant to deploy RFID-based e-pedigrees, citing a number of factors for their delays.
First and foremost was the up-front cost of RFID. Manufacturers incur expenses from tagging and coding drugs before they enter the supply chain, while distributors and pharmacies sustain additional costs from deploying RFID interrogators and antennas at distribution and retail points. With no immediate return on investment, drug companies were initially reluctant to invest in the infrastructure necessary to create an RFID-based e-pedigree.
Consumer privacy is another key issue. Drug companies have expressed concern that if RFID tags containing identifying information were still on the drugs when they were sold, the firms could be found liable if unauthorized individuals were to intercept personal information without the purchasers' knowledge. The electronic product code (EPC) in RFID tags contains substantial bit capacity, enabling the assignment of individual identifiers to RFID tags. RFID can collect a good deal of personal information on tags, and in company databases, so drug companies fear that information might be accessible to experienced computer hackers and other unscrupulous individuals.
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In 2003, the FDA released a report recommending that pharmaceutical companies use RFID to create e-pedigrees for tracking prescription drugs as they are distributed into commerce. With a unit of drugs tagged at the manufacturer, and with RFID interrogators tracking that unit through the supply chain to the pharmacy, the authenticity of the product could be assured. Soon thereafter, the organization implemented pilot programs and publicly declared that by 2007, it would like to see U.S. drug companies implement RFID to track all prescription drugs at the unit level.
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First and foremost was the up-front cost of RFID. Manufacturers incur expenses from tagging and coding drugs before they enter the supply chain, while distributors and pharmacies sustain additional costs from deploying RFID interrogators and antennas at distribution and retail points. With no immediate return on investment, drug companies were initially reluctant to invest in the infrastructure necessary to create an RFID-based e-pedigree.
Consumer privacy is another key issue. Drug companies have expressed concern that if RFID tags containing identifying information were still on the drugs when they were sold, the firms could be found liable if unauthorized individuals were to intercept personal information without the purchasers' knowledge. The electronic product code (EPC) in RFID tags contains substantial bit capacity, enabling the assignment of individual identifiers to RFID tags. RFID can collect a good deal of personal information on tags, and in company databases, so drug companies fear that information might be accessible to experienced computer hackers and other unscrupulous individuals.
