Feb 10, 2006Two years ago, the U.S. Food and Drug Administration (FDA) endorsed the use of RFID technology, along with other technologies, to help track and trace pharmaceuticals—securely and accuratelyfrom manufacturer to distributor to retailer—as a means of fighting the growth of counterfeit drugs. Though it hadn’t issued a mandate, the FDA had hoped that by 2006, tagging would be at the individual unit level for all drugs likely to be counterfeited, with all drugs being tagged at the pallet, case and unit levels a year later (see FDA Endorses RFID Technology.)
Activity among drugmakers toward meeting those goals—or, more accurately, the lack thereof—prompted the FDA to pull together several hundred regulators, pharmaceutical companies, wholesalers, retail and small independent pharmacies, industry associations and technology providers to discuss this issue. The FDA Anti-Counterfeit Drug Initiative Public Workshop, a two-day event held this week in Bethesda, Md., was created to identify the hurdles that have caused the slower-than-expected movement toward widespread RFID use, and to determine what must be done to accelerate testing and deployment of the technology.
At the meeting, acting FDA Commissioner Andrew von Eschenbach asked the FDA's Counterfeit Drug Task Force to file a new report to the FDA by May 2006, containing recommendations on how the agency should move forward to make the pharmaceutical supply chain more secure. Among the questions posed: Should it require drug sellers to use an electronic pedigree, a secure record documenting that the drug was manufactured and distributed under safe and secure conditions? And should any e-pedigree requirements also include a mandate to identify each bottle with a serial number encoded to an RFID tag?
The meeting was held Feb 8 and 9. A number of drugmakers, including Pfizer and Johnson & Johnson, presented summaries of their efforts to test RFID and e-pedigrees. Representatives from several industry associations, among them the National Association of Boards of Pharmacy (NABP), the Pharmaceutical Research and Manufacturers Association (PHRMA) and the Healthcare Distribution Management Association (HDMA), provided their perspectives. Carmen Catizone, the NABP's executive director, stressed that the FDA's 2004 recommendations for the widespread use of RFID in track-and-trace deployments can and should be realized.
To date, however, Purdue Pharma is the only pharmaceutical manufacturer to announce publicly an electronic pedigree pilot involving RFID (see Purdue Pharma to Run Pedigree Pilot). Pfizer is using RFID to track bottles of Viagra as an anticounterfeiting measure (see Pfizer Using RFID to Fight Fake Viagra), but is not yet including item serialization as part of an e-pedigree system.
According to pharmaceutical industry representatives attending the meeting, one hurdle facing RFID tagging is a lack of a single frequency standard. Some pharmaceutical companies must comply with Wal-Mart Store's mandate to track shipments of drugs with ultrahigh-frequency tags, but many of these same companies find that UHF tags do not perform as well as high-frequency tags at the item level. As such, Pfizer is using HF tags in its Viagra trial.
Next month, EPCglobal plans to conduct a series of hardware tests, which will include item-tagging scenarios. The performance of HF and UHF hardware systems will be considered against a long list of requirements, such as read range and packaging materials, that manufacturers, distributors and other members of the pharmaceutical supply chain have provided, says Bob Celeste, director of EPCglobal US's Action Groups. "It's not just tags that we'll be testing," he says. "We'll also be looking at things such as antenna placement."
According to Celeste, concerns regarding the use of tags operating at different frequencies are based on the subsequent need for pharmaceutical supply chain trading partners to have multiprotocol interrogators (readers) able to read both HF and UHF tags. This could increase infrastructure costs for companies that have already invested in single-protocol readers, but the frequency used is not important for the creation of an e-pedigree, he says—or the sharing of that data between trading partners.
"Because we will be operating in a mixed environment [with some companies using item-level serialization, facilitated through RFID, and others not serializing or using RFID], we have developed standards that accommodate both approaches," says Celeste. The pedigree messaging standard working group has completed a first draft of the messaging specification standard candidate, and has submitted it to the EPCglobal standardization process. Lucy Deus, a member of the working group and vice president of product development at SupplyScape, says software companies can now start building their e-pedigree platforms around the candidate, which describes how data shall be formatted, authenticated with digital signatures, and shared between supply chain partners. VeriSign and SupplyScape say they have already established the specifications in their platforms.
One issue brought to light during the two-day meeting, says Deus, is that an electronic pedigree does not require item-level serialization—and, therefore, does not require RFID. Some comments and questions she heard during the meeting gave Deus the impression that this decoupling was not initially clear to all attendees. "That's an important distinction," she says, "because if you look purely at e-pedigree, companies are already deploying e-pedigree systems, but without serialization."
Bruce Harder, a VeriSign spokesmen and also a member of the pedigree working group, notes that establishing a standard for data-sharing between e-pedigree platforms is a very important step, part of the groundwork needed before companies can begin sharing item-level RFID data related to pedigrees.
