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FDA Issues New 'Counterfeit Drug Task Force' Report
The agency will not mandate RFID's use within the pharmaceutical industry, but urges the industry to 'move quickly to implement this technology.'
Instead, Chang recommends, companies will store NDCs and related data on back-end systems, and then cross-reference the tag's EPC code to that back-end data. "My sense is most companies will just use the license-plate approach [of using the EPC code only], so there is no pertinent information on the tag, just a number that will be used as a reference to get information," Chang says. "And that crushes the privacy debate. If you have specific information on the tag itself, there are probably some means for people to read the tag and perhaps figure out what drug you are taking. Without the NDC on the tag, you'd have to hack into multiple databases to figure out what that number means. I'm not sure you'd use the word impossible, but it is very, very difficult to hack into multiple databases and figure out what that drug is."
The report also recommends the ending of a temporary "hold" on regulations related to the Prescription Drug Marketing Act of 1987. That act requires drug distributors to document (via a pedigree, though not necessarily in electronic form) the chain of custody of drug products as they move through the distribution system. According to the FDA, the hold—initiated because there were concerns that pedigrees would have a negative impact on small wholesalers—will expire in December and not be extended.
The task forces also offered the following recommendations: that the FDA issue a draft Compliance Policy Guide for public comment, focusing FDA's pedigree-related enforcement efforts on those drugs most vulnerable to counterfeiting and diversion; that stakeholders continue moving forward in implementing RFID across the drug supply chain and adopt a phased-in approach, placing RFID tags on those products most vulnerable to counterfeiting and diversion as a first step; and that the FDA work with manufacturers and other stakeholders in their efforts to develop appropriate messages, symbols or statements for the labeling of drug products and packaging that contain an RFID tag.
Eschenbach has indicated his endorsement of the report and all its recommendations. The task force, however, remained undecided on one major issue: whether an RFID tag should be deactivated before it leaves the pharmacy, or if patients should be given the choice of determining whether to turn it off. "We recognize that this is an important issue, but do not have sufficient information to make a recommendation at this time," the group wrote.
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