All Eyes on FDA for Drug E-Pedigree

In 2004, the California State Board of Pharmacy first issued a pending e-pedigree requirement for the prescription drug industry operating in the state, with a deadline of Jan. 1, 2007. In 2006, the board moved that deadline back to 2009 to allow the industry more time to implement technologies. An e-pedigree, the board ruled, can be accomplished using bar codes or RFID technology. In January 2008, the board asked for industry input prior to its March 25 meeting in San Diego, and as a result of those responses, issued the 2011 extension of the requirement.

The new deadline is one year later than the FDA's intended implementation of e-pedigrees on a federal level. In summer 2007, Congress gave the agency 30 months to develop a pedigree requirement that would be federally mandated. If the FDA meets that deadline, the requirement will take effect in January 2010. In the meantime, the FDA is seeking comments from drug manufacturers, pharmacies, distributors and other industry stakeholders.

Ronald E. Quirk, Jr.

A federally mandated program may be a better solution for the pharmaceutical industry than a state-mandated one, says Doug Farry, director of government relations practice at McKenna Long & Aldridge and chairman of the firm's RFID practice group. If California's mandate were different than another state's or the FDA's, he points out, the pharmaceutical industry would have a problem complying with multiple requirements.

With the FDA now the only governing body looking closely at an e-pedigree requirement by 2010, the federal agency has the opportunity to set a nationwide standard for an e-pedigree system, as well as which technology should be used and what policies should be in place for enforcement. However, Farry says, the resolution of policy issues, such as enforcement and liability, may be the greatest obstacle, and was very likely one reason California issued a delay of two more years. Those yet-to-be-determined policies include spelling out who will be held liable if a product is found to be counterfeit after the e-pedigree system is put in place, as well as clarifying which parties will be responsible for what happens in specific parts of the supply chain.

"My belief," Farry says, "is that regardless of what [technology] standards they—either California or the FDA—still have, the challenge is, How is this enforced?" He notes that overseeing and enforcing rules for the entire pharmaceutical supply chain, from manufacturer to retailer, would be a difficult task for the FDA. "What enforcement mechanism will they have in place? That is going to remain a challenge," he states. The prescription drug industry, he adds, may be balking not only at implementing technology by 2009 (as per California's former deadline), but also at the fact that enforcement and liability policies have not yet been established.

"I would argue that it is the difficulty in resolving policy questions that is more the issue than the technology," Farry says. "I believe policy issues are slowing this down. Those who are being asked to implement the technology are hesitant to invest money in a system without knowing what the rules are going to be—what's my liability if I put this into place?'" Farry, however, believes the FDA can still answer such policy questions by the federal agency's deadline. "Can they be resolved? Sure, there is certainly time. It depends on the different players feeling incentivized to come to the table to come up with win-win solutions."