All Eyes on FDA for Drug E-Pedigree

The FDA has testified to Congress that RFID is the most promising technology for a drug-pedigree system, but Congress has also recommended considering holograms and microdots, similar to those found on U.S. currency, as well as bar codes. What's more, the federal agency is also reviewing the standardization of serial numbers—the unique numerical identifier for use with RFID or bar-coding technology.

An e-pedigree system would require a unique serial number be placed on each item being tracked, but there is no current standard specific to the serial numbers used. "I think serialization is the biggest problem," says Ronald E. Quirk, Jr., counsel at Washington, D.C., law office Venable LLP. Quirk indicates that until a serialization standard is determined at the FDA, it is prudent for the state of California to delay any regulations specific to an e-pedigree.

Aaron Graham

Some pharmaceutical companies, including Cardinal Health (see Cardinal Health Deploying Drug E-Pedigree System) and Purdue Pharmaceutical, have already implemented an electronic tracking system using RFID in their supply chain. Purdue began investigating electronic tracking in 2002, and started piloting an RFID-based system in 2005 (see Purdue Pharma to Run Pedigree Pilot).

At present, Purdue Pharma tags every bottle of OxyContin it ships with an EPC Gen 2 RFID tag. "When we first implemented the system, there was no legislation on the horizon," says Aaron Graham, the company's VP and chief security officer. Independently, Purdue was seeking ways to ensure the safety of the supply chain, and discussed 2-D bar codes before opting for RFID technology. With bar coding, he points out, "You need line of sight—and when you're moving thousands of units, that is not efficient."

Purdue's early start in RFID gave it an advantage others in the industry don't have, Graham says. "People are seriously concerned about public health," he states, "but it's not a simple solution—we got a running start at it." Graham says he doubts the industry could have met the 2009 deadline, and that the additional time will enable both the pharmaceutical company and RFID vendors to catch up. "I think if every drug manufacturer was held accountable [by 2009], there would be a problem with the supply of tags," he says, adding that currently, "there aren't enough available tags in the world economy." The new deadline extension, he says, is "realistic and viable."