Pfizer Prepares for Viagra E-Pedigree Trial

Presently, 15 states have laws requiring drug pedigrees, Spellman says, while seven states have legislation pending, with five more expected to introduce legislation this year. A California law calling for e-pedigrees takes effect in 2009; originally, the state's e-pedigree legislation was supposed to take effect in January 2007, but Spellman says that law has been pushed back two years. Drug manufacturers, wholesalers and distributors must comply with the requirements outlined in the various laws.

Although Pfizer is satisfied with its use of HF tags on bottles, Spellman states, the company is still working out the details of its e-pedigree project. A number of other companies are finding themselves in the same situation as well. "Across the market," he notes, "pharmaceutical manufacturers are engaging with us to figure out fundamentally what their e-pedigree strategy is, to get experience with their supply chain. And they all want to make sure they are ready for the California 2009 date."

According to Staver, Pfizer's aggressive stance on RFID and e-pedigrees is spurred by an increase in drug counterfeiting. As of Dec. 31, 2006, the drugmaker had found counterfeits of its products in at least 69 countries. "This is a significant issue for all of us in our industry," she told webcast attendees.

Counterfeit drugs pose serious health threats, Staver said. "The [counterfeit] drugs are often manufactured in unsanitary conditions, in unregulated and unlicensed sites, and the packaging methods are drastically different." In some cases, she added, the drugs don't contain any active ingredients, such as the counterfeit versions of Norvasc—a drug used to treat high blood pressure and the chest pain of angina—that Pfizer found in the fall of 2005 in a pharmacy in Hamilton, Ontario. At other times, dangerous additives are used—in one case of counterfeit Viagra, Staver said, traces of boric acid and brick dust were found.

"Our mission and our vision, as our starting point, is to enhance patient safety by implementing effective U.S. channel security strategies that protect our products and reduce the threat posed to the channel by diverters and counterfeiters," Staver told attendees. "This is an internal mission for Pfizer, but clearly this is of interest to other manufacturers."

Pfizer, she said, is very committed to looking at using RFID in other aspects of Pfizer's supply chain, including shipping and receiving.