FDAnews
www.fdanews.com/articles/77832-pfizer-enlists-rfid-technology-to-fight-product-counterfeiting

Pfizer Enlists RFID Technology to Fight Product Counterfeiting

January 17, 2006

Proponents of radio frequency identification (RFID) tags received a boost earlier this month when Pfizer said it had begun to ship its first product – Viagra – with the tags embedded. Viagra was chosen because it has been a major target of counterfeiters, the company said in a Jan. 6 release.

While RFID still faces an uphill acceptance battle from FDA-regulated life sciences firms wary of its high price tag, Pfizer’s move in its direction is helping companies, especially larger ones, see that its value might be worth the cost, experts tell PIR.

“The decision life science firms must make is whether or not to mass serialize their products,” said Dan Walles, senior product manager for SupplyScape, a vendor on the Pfizer project. “If companies decide to serialize, then a decision on what serialization technology is most appropriate – RFID or barcodes – must be made,” he added.

Track and Trace Trail

RFID, although not ready for mass adoption, provides a significant upside in its ability to help firms “track and trace” their products, Walles noted. “Initiatives such as Pfizer’s Viagra project provide significant opportunities for supply chain partners to understand the impact RFID will have on their operations,” he said.

Pfizer said it is working cooperatively with standards-setting bodies, state governments, the FDA, industry groups and its customers to establish policies for the widespread application of RFID in the future. But, while the technology offers great promise as an anti-counterfeiting tool, Pfizer agrees it alone will not eliminate drug counterfeiting.

“Pfizer believes the problem must be addressed on many different fronts, including tightening state regulations for the licensing and distribution of pharmaceutical products, modifying business practices, increasing enforcement and using technology effectively,” the company said in a statement.

Pfizer, like many industry players, anticipates that it will take several years before RFID is applied broadly throughout the pharmaceutical industry. Cost will be a significant consideration, as will the readability and reliability of RFID tags. Standards must also be developed to govern technology and data exchange.

Moving Forward

The pharmaceutical industry may not meet the FDA’s 2007 goals for widespread track-and-trace technology adoption, an agency official told lawmakers on Capitol Hill in November, but they are making good progress toward adoption (PIR, Nov. 23, 2005, Page 6). Widespread RFID development and implementation requires technology standards to ensure interoperability, and the FDA will continue to support those efforts, said Randall Lutter, acting associate commissioner for policy and planning.

The agency is hosting a two-day RFID workshop and vendor display next month in Maryland, where SupplyScape and others will be on hand to take company questions and provide demonstrations of RFID technology.

RFID may even have applications for other regulated life sciences firms back in the warehouse or production facility. For example, it may be able to help device firms meet traceability requirements under 21 CFR Part 820. While that has not been an initial focus at SupplyScape, Walles said the company continues to investigate other opportunities. Several other RFID vendors, including SecureRF and Printronix, have recently announced product updates aimed at the pharmaceutical industry.

For additional information about Pfizer’s RFID program, go to http://www.pfizer.com/counterfeit. — Michael Causey