The US Food and Drug Administration must decide by the end of the year whether to implement a rule that requires drug manufacturers to have a system in place that can track a drug's pathway from the manufacturer to the final dispenser, even if it means starting with an outmoded paper-based pedigree system. The policy aims to thwart drug counterfeiting, which is on the rise around the world, threatening public health as well as manufacturer revenues. Although FDA has delayed action, individual states and major retailers are responding by implementing their own drug pedigree requirements. Manufacturers are participating in pilot tests of new systems to see how well they can track drugs through the distribution chain, as well as prevent tampering and identify fakes. So far, most solutions appear costly but promise to earn their worth by modernizing inventory and distribution systems and avoiding legal and regulatory problems.
Pedigrees on hold
FDA held a public workshop in early February to examine what progress has been made in implementing electronic track-and-trace technologies during the past two years, focusing particularly on incentives and obstacles to establishing a radio frequency identification (RFID) system (see Glossary of security and anticounterfeiting terms). As part of its anticounterfeiting objectives, the Prescription Drug Marketing Act of 1987 (PDMA) requires unauthorized wholesalers to provide purchasers with a statement (or pedigree) presenting a history of prior sales of the drug and the names and addresses of parties to these transactions. The legislation also aimed to control drug counterfeiting and illegal diversion by requiring states to license wholesale distributors of prescription drugs and by controlling drug sampling. Those provisions were implemented years ago, but wholesalers objected strongly that a pedigree system would be costly and impossible to establish. FDA agreed to delay implementation until manufacturers, distributors, and pharmacists could develop a workable approach.
By 2004, the solution appeared to lie in establishing an electronic tracking system that uses RFID technology. An FDA counterfeit drug task force issued a report that examined technological and policy developments related to drug counterfeiting and concluded that the agency should postpone the pedigree requirement once more to provide time to implement an electronic tracking system by 2007.
Nonetheless, at the FDA workshop in February, participants acknowledged that the implementation of a workable tracking system using RFID technology is still years away. Progress has been "disappointing," commented FDA Deputy Commissioner Scott Gottlieb at a drug anti-counterfeiting forum sponsored by the Parenteral Drug Association (PDA, Bethesda, MD,
http://www.pda.org/) this past month. He noted a lack of agreement on key issues such as who pays for RFID and who owns transaction data.
Now, the agency's Counterfeit Drug Task Force, which is chaired by FDA Associate Commissioner for Policy and Planning Randall Lutter and Associate Commissioner for Regulatory Affairs Margaret Glavin, is scheduled to report back in May about whether to delay the pedigree rule once more or to implement the requirement, possibly with some changes.
With pressure mounting to do more to protect the nation's drug supply from counterfeiting, tampering, and diversion, another stay seems unlikely. The task force will lay out the options, examine available tracking and authentication technology, describe the multiple levels of protection needed to better secure the nation's drug supply, and provide additional policy guidance to spur all parties in the supply chain to move forward. Policy makers now recognize that RFID is not a magic bullet and that an effective system requires universal standards, new information systems, and access to a range of protective strategies.
Glossary of security and anticounterfeiting terms
One problem is that manufacturers, wholesalers, and pharmacists disagree about how best to address these issues. Pharmaceutical companies want FDA to implement the pedigree policy, predicting that this will force everyone to agree on strategies for securing the supply chain. Companies support joint efforts to harmonize standards for data transmission, but want control over how they use those standards.