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As most of you know, there’s been a lot of hype surrounding radio-frequency identification (RFID) lately. At many of the industry conferences and events we’ve attended during the past year, the buzz has been all about how RFID might be implemented, how it could potentially work as a track and trace technology, and how FDA might eventually require its presence in your supply chains.

Well, that buzz is quickly becoming reality. FDA made it clear last week that RFID will play a central role in its anticounterfeiting plans. Though the agency stopped short of using the words “requirement,” it announced a new Compliance Policy Guide for implementing RFID feasibility studies and pilot programs. The agency also announced that it is creating an internal RFID workgroup with the task of monitoring adoption of RFID in the pharmaceutical supply chain. FDA believes that this workgroup will “improve communication with members of the supply chain on RFID issues and should facilitate both the performance of pilot studies and the collection of data needed to formulate policy,” according to an agency statement. “We’ve stepped up our efforts,” said Lester Crawford, acting FDA commissioner at the press conference announcing the initiatives. “This will accelerate the use of RFID technology. FDA is determined to protect the public.” So determined that the agency says it will exercise enforcement discretion if studies falling within the Compliance Policy Guide’s parameters trigger regulatory requirements.

FDA believes the creation of the policy guide will clear the way for RFID pilot programs that involve tagging of drug packages. It also expects that studies and research into RFID tag numbering, optimal frequency use, and database management will be accelerated. The bottom line: almost overnight, the agency has made it clear that RFID is the direction it wants pharmaceutical companies to go in terms of track and trace and anticounterfeiting.

But thankfully, industry appears to be taking the lead in heeding FDA’s latest call to action. In fact, some of the larger pharmaceutical companies had announced wide-ranging RFID plans in advance of FDA’s new initiatives. The same day the agency made its announcement, it also went out of its way to acknowledge the current RFID pilot programs being implemented by Pfizer, GlaxoSmithkline, and Purdue Pharma. Pfizer, in perhaps the biggest of the pilots, will soon be placing RFID tags on all bottles of Viagra in the United States. GSK will use RFID tags on an unnamed drug product that it calls “susceptible to counterfeiting.” And Purdue Pharma is currently placing RFID tags on bottles of its popular painkiller OxyContin. The company is also putting tags on Palladone, another of its painkilling medications. Johnson & Johnson was also publicly cited by FDA as a leader in “establishing standards for RFID technology and participating in RFID studies.”

RFID obviously still has many concerns to be addressed before it becomes an industry standard. From cost questions to frequency issues, there’s much to be determined about this promising technology. But it is certainly exciting to see industry so willing to take on that challenge. Pfizer, Glaxo, Purdue, and J&J should all be applauded for bravely taking the lead on pilot implementation. No doubt their findings will pave the way for future RFID use and perhaps even lead the way for other anticounterfeiting technologies.