Drug Pedigree Mandate Could Be Expensive

Unlike the PDMA, which requires only drug distributors to create and maintain pedigrees, HR 5839 also calls for manufacturers and retail pharmacies to employ a drug identification and tracking system to create and maintain pedigrees. Florida's law requires only wholesale distributors to create pedigrees, while California's proposal includes manufacturers, distributors and retailers.

What many, including the coalition of pharmacies, would prefer—if, indeed, there are to be any government mandates—is a federal mandate that would supersede state laws. "We'd like to see a federal system, as opposed to 50 systems," Sewell says. However, he notes, the government must be more specific in its requirements. "There needs to be a single technology identified that multiple vendors could provide," he explains, rather than allowing for multiple technologies, such as both RFID and 2-D bar codes. "If we have to support more than one technology, that adds to the costs."

While HR 5839 does include a clause calling for the Secretary of Health and Human Services to award grants to "eligible entities to facilitate the purchase and enhance the utilization of a drug identification and tracking system," it also requires those entities to generate matching funds. According to Sewell, grants should cover all of the hard costs associated with a track-and-trace system, in terms of hardware and software, because retail pharmacies will still need to fund the time and resources for the administration and compliance of such a system.

"We want to work with the government to come up with a cost-effective track-and-trace solution," Sewell states. "But if you just pass legislation that sort of says, 'go do it,' it leaves everything to the regulatory agency to determine how it will be done. We have no confidence that it will get done in a fashion that will be beneficial to either our pharmacies or the consumers."

Rather than enacting a federal mandate such as HR 5839, NACDS suggests Congress institute federal requirements for uniform state wholesale drug distributor licensure standards; implement an FDA-administered certification program for manufacturers, distributors and pharmacies assuring adherence to secure supply chain practices; require chain-of-custody pedigrees only for distributions by uncertified supply chain entities; and ensure a uniform and strong national safety regimen through federal preemption of state laws.