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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 FDA should seek guidance from GS1's EPCglobal division for recommending an RFID standard, the board wrote.

GS1, in its own public comment, indicated that the FDA, whether using 2-D bar-coding or RFID technology, should follow a GS1 standard. "We recommend that the FDA work with the industry and provide them enough room to develop [a system] that is best for them," says Bob Celeste, GS1's health-care director. Celeste points out that Florida's efforts at developing a statewide e-pedigree system resulted in nothing more than a paper-based pedigree system, in part because the initial system was too rigid. "That makes it difficult for industry to comply," he says.

When it comes to technology other than RFID, the California Board of Pharmacy stated, "We are unfamiliar with any encryption technology or nanotechnology applicable to this task." That leaves 2-D bar codes and RFID tags, and of the two, the board reports, "RFID is a vastly superior technology for all of the purposes served by an electronic pedigree/track and trace system, and should be the industry standard for data carriers." The board added that, "2-D bar codes have utility as a temporary or interim solution, and as a backup technology on packaging in the event of a (rare) RFID tag failure."

According to the board, the only disadvantage that RFID has compared with 2-D bar codes is its higher cost of implementation. "But RFID costs have plummeted recently, and will fall farther. Moreover, the costs of RFID are substantially outweighed by its benefits," wrote the board, noting that RFID tags are less easily counterfeited or duplicated than are other data carriers, including 2-D bar codes.

Addressing a concern as to whether RFID has an effect on the quality of the products' biologics, the board stated, "To date, all of the available data of which the board is aware suggests there is no such effect, and the board has not been made aware of any studies or data demonstrating any such effect."

Pharmaceutical company Merck advised the FDA to consider a single numeric identifier standard with structured codes rather than national drug code (NDC) numbers to protect privacy and to avoid duplication in the field. NDC numbers would identify which kind of product is being transported. "We recommend reliance on a global serialization standard that GS1 Healthcare would determine," the company wrote in its submitted comments.

GS1 currently utilizes a global trade identification number (GTIN) that includes an NDC. While the NDC indicates the kind of product, it is not recognized outside the United States. With the GTIN, however, the NDC can be used in the United States while the GTIN itself is still recognized outside of the United States. In this way, says Celeste, a product could be shipped from one country and the same identifier could be used there as well as in the United States.

USER COMMENTS

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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