At a meeting organized by the U.S. Food and Drug Administration, drugmakers, pharma distributors and technology providers discussed the challenges ahead in using RFID to make the drug supply chain safer.

By Mary Catherine O'Connor

Feb. 10, 2006—Two 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 accurately—from manufacturer to distributor to retailer, as a means of fighting the growth of counterfeit drugs. And without issuing a mandate, the agency hoped that by 2006, tagging would be at the individual unit level of all drugs likely to be counterfeited, and by 2007, it envisioned all drugs being tagged at the pallet, case and unit levels. (See FDA Endorses RFID Technology.)

Activity, or, more accurately, lack thereof, among drugmakers toward meeting those goals prompted the FDA to pull together several hundred regulators, pharmaceutical companies, wholesalers, retail and small independent pharmacies, industry associations and technology providers for a two-day FDA Anti-Counterfeit Drug Initiative Public Workshop this week in Bethesda, Md., to identify the hurdles that have caused the slower-than-expected movement toward using RFID and to identify what needs to 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 with recommendations on how the agency should move forward to make the pharmaceutical supply chain more secure. 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)? Should any e-pedigree requirements also include a mandate to identify each bottle with a serial number encoded to an RFID tag?

At the meeting, 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, and representatives from industry associations, including the National Association of Boards of Pharmacy (NABP), the Pharmaceutical Research and Manufacturers Association 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.

But to date, Purdue Pharma is the only pharmaceutical manufacturer to publicly announce 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.

Florida has passed a bill, going into effect July 1, requiring all companies selling drugs in the state to provide an electronic pedigree. It does not, however, require the use of RFID or item serialization. California has also passed an e-pedigree bill, not yet in effect, and the state might include a requirement for item-level serialization via RFID. A number of other states are set to begin requiring e-pedigrees for prescription drugs.

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'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. That's why 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, the 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, the concerns about using tags operating at different frequencies are based on the subsequent need for pharmaceutical supply chain trading partners to have multiprotocol interrogators (readers) that can read both HF and UHF tags, which could increase infrastructure costs for companies that have already invested in single-protocol readers. But regarding the creation of an e-pedigree or the sharing of that data between trading partners, the frequency used is not important, he says.

Through its Healthcare Life Sciences Business Action Group (HLS BAG), EPCglobal has established a pedigree messaging standard working group. It includes representatives from companies involved in e-pedigree deployments, such as e-pedigree software platform providers VeriSign and SupplyScape, to establish standards addressing how electronic pedigrees should be created, maintained and shared, so that all companies required to provide and authenticate the pedigrees may do so using software platforms from different vendors. The group establishing the standards must make them applicable to e-pedigree systems whether RFID is used or not.

"Because we will be operating in 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 submitted it to the EPCglobal standardization process. Lucy Deus, a member of the working group and the vice president of product development at SupplyScape, says that 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 of the issues 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 of the comments and questions she heard during the meeting gave Deus the impression that this decoupling was not initially clear to all of the 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, 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 and part of the groundwork needed before companies can begin sharing item-level RFID data related to pedigrees.