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Industry Opinion Favors RFID for Drug E-pedigree

Comments received by the FDA show a preference for RFID technology—generally EPC—for a pharmaceutical e-pedigree identification system, with 2-D bar-coding as a backup.
By Claire Swedberg
The estimated cost for retail pharmacies to comply with a mandate that included RFID or 2-D bar-code technology would be tens of thousands of dollars per store and in excess of $1.6 billion for all the drug stores in the United States, according to the NACDS. These numbers do not include the costs associated with rolling out the technologies in pharmacy distribution centers and costs to adjust to changing technologies.

The HDMA urged the FDA to publish its intentions specific to standards and allow the industry an opportunity to respond before finalization. It also requested the FDA to continually evaluate the standards as counterfeiters work around any standard, and revise them as needed.

Teva Pharmaceutical Industries recommended either using 2-D bar-coding, which it calls "a widely accepted and cost-effective" technology with the ISO ECC 200 standard, or UHF EPC Gen 2 RFID tags with bar-coding as a backup. "RFID is a promising technology but the readability and cost are barriers for it immediately becoming the standard." Because the readability is not reliable, the company wrote, a backup technology would still be necessary in the event an RFID tag failed.

And the Generic Pharmaceutical Association (GPhA) noted that RFID as well as encryption and nanotechnologies are "nascent and currently not robust enough to ensure a smooth and orderly flow throughout the drug supply chain." RFID is a promising technology, but the readability and cost are barriers for it becoming the standard, the association stated.

Drug manufacturer Pfizer indicated that the FDA should not mandate one technology. "Leave this to the market and individual organizations to decide based on the unique characteristics of the products involved," Pfizer wrote. "If RFID is used for serialization purposes, a second data carrier also will need to be used for select products."

Drug distributors indicated a preference for RFID technology. McKesson stated that it "supports the use of RFID and product serialization at the point of manufacture. In order for this technology to be implemented, manufacturers must embrace RFID and assume the responsibility for placing electronic tags that uniquely identify their products."

Automatic identification association AIM Global indicated that RFID with bar coding as a secondary system was the best solution.

Other alternative authentication systems were recommended by technology vendors. For example, XStream Systems produces a material identification system as an alternative or added layer of authentication. "Our systems perform nondestructive testing of powders, liquids, and pills, all while still sealed in their finished packaging," the company commented.

Bar-code label and UHF EPC Gen 2 RFID tag manufacturer Avery Dennison submitted comments favoring the adoption of RFID. The company also plans on responding to some of the public comments, says attorney Ronald Quirk, who represents Avery Dennison. Potential harm to biologics, he says, has not been proven in any testing that he is aware of. "There may need to be more studies done," he adds. In a letter to the FDA, he wrote that Avery Dennison will also address the concern regarding cost. He points out that the cost of Gen 2 UHF RFID tags was approaching the cost of 2-D bar-code labels as the tag costs continue to drop. They are currently 10 cents a tag or slightly less. "Whatever recommendations the FDA comes out with will increase sales exponentially of whatever technology they endorse," which will serve to lower per-unit costs even further, Quirk adds.


Andrew Strauch 2008-05-30 11:56:01 AM
The RFID Tag Physical Security Hole The general benefits of RFID for pharmaceutical e-pedigree applications are well stated in the FDA public comments. However, one major assumption must be addressed. Assuming that typical RFID tags are less likely to be counterfeited or duplicated is extremely dangerous. As it stands, RFID systems track RFID tags – not the asset to which the tag is attached. Counterfeits can simply remove the tags without affecting the RFID function. The tags can then be placed on counterfeit items, or placed back in the empty carton. The reader will be none the wiser. Robust tamper evidence is needed to ensure a unique relationship between the RFID tag and the actual pharmaceutical product. Without this, the pharmaceutical industry cannot be certain that e-pedigrees remain secure. According to the U.S. Chamber of Commerce, the pharmaceutical industry loses $32 billion annually to counterfeiting. With that much revenue on the line, the pharmaceutical industry must stay at least one step ahead of counterfeiters. This means physical security on top of data security. Andrew Strauch MIKOH Corporation

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