Splitting the Difference

The Food and Drug Administration seems ready to split the difference on radio frequency identification (RFID) tagging of pharmaceuticals, which drug users and technology vendors say is ready for prime time, but pharmaceutical companies and distributors say is too immature and costly to use at this time.

At a reconvening of the FDA Counterfeit Drug Task Force on February 8-9, 2006, Holiday Inn Select in Bethesda, Maryland, acting FDA Commissioner Andrew von Eschenbach said what other FDA officials had been saying for months. "I am disappointed at the apparent slowdown in RFID implementation," he stated. The FDA issued a task force report in February 2004, which said the agency expected widespread adoption of RFID tagging of drugs in 2007 based on what it heard in workshops held in 2003.

Lost Opportunity

But at the meeting, where a crowd of 200 packed the ballroom, Eschenbach emphasized: "The longer we delay, the more opportunity is lost." He announced that he had asked the task force, composed solely of FDA regulatory, legal and enforcement officials, to submit recommendations to him by May, not only on a potential FDA mandate on RFID implementation, but on what the agency should do at the end of 2006 when the "stay" on a requirement for pedigrees on drugs moving through the distribution system expires.

Pfizer, the only brand-name prescription company that has a commercial RFID implementation going on with Viagra, was represented by Tom McPhillips, vice president, U.S. trade group. "It would be possible to implement RFID tagging for higher risk products in three to five years," said McPhillips in an opening statement. "It would take several years beyond that before all drugs could get tags."

Carmen Catizone, executive director of the National Association of Boards of Pharmacy emphasized, "An implementation date of 2007 is possible and must be possible."

Searching for Standards

There is no question that the failure of the EPCglobal Health Care and Life Sciences work group to settle on RFID tag and reader frequency standards is a major, if far from the only, impediment to wider-scale adoption. "The endless array of competing tag systems will lead to gridlock," says John Gray, president of the Healthcare Distribution Management Association.

EPCglobal did publish a Gen 2-UHF air interface protocol for multi-purpose use in all industries in December 2004. But that is useful primarily for companies complying with Wal-Mart's requirements for UHF tags on cartons and pallets and, in some instances, controlled substances, on item-level drug packages. "Right now, four suppliers are tagging pharmaceuticals at the package level, on over 20 SKUs," says Ron Moser, strategic RFID analyst at Wal-Mart. "They are all using UHF tags. We have plans to expand item level tagging beyond those 20 SKUs."

However, a number of technology vendors exhibiting products at the workshop explained that the Gen 2 UHF tag has limited application for drug packaging, a fact born out, perhaps, by Pfizer's choice of an HF tag for its Viagra package. "Gen2 may work for a case of hot dogs, but not for a container of pills worth $150," says Jan Svoboda, business development director, UPM Raflatac Inc.

Svoboda emphasized that HF tags work very well on drug packages right now, and have significant advantages over UHF tags in greater security, memory and higher read rates when placed on blister packs, other packages with metals and those containing liquids. He acknowledged that HF tags are somewhere between 50 percent and 100 percent more expensive than UHF tags, depending on volumes. But he said a focus on cost is shortsighted. "If you are a distributor in Florida and you can't authenticate a drug package, you can go to jail." Substantial expansion of Florida's current wholesale drug pedigree requirements go into effect in July 2006.

HF Versus UHF

Ed Gonsalves, business development manager, Philips Electronics, agreed that HF tags are a better choice for drugs right now. "The reason EPCglobal has focused on UHF is Wal-Mart, which took a one-size-fits-all approach to tags," he stated. "And I understand that from their point of view." Gonsalves expects EPCglobal to adopt both UHF and HF standards for drugs.

Pfizer's McPhillips defended the pace at which EPCglobal is moving. "The EPC global standards process is not a simple solution. There are a number of different people who need to be heard. We will get there sooner rather than later."

That process will inch forward in late March 2006 when EPCglobal holds what Gonsalves referred to as a "bake off" at an Infineon Technologies AG facility in San Jose, California. Gonsalves said there will be seven or so "use cases," where applications are set up and different products and frequencies are tested. "Three or four of those will be pharmaceutical industry use cases."

While everyone at the workshop agreed that RFID wider adoption depends on drug industry-specific standards, Mike Rose, vice president, RFID/EPC Global value chain, Johnson & Johnson, asked the FDA to get "actively involved" in the EPCglobal process by assigning a staff person to the effort full time. Rose also emphasized that issues beyond standards also need to be resolved, including the need to settle business practice and data sharing issues, which will not be settled in the standards realm.