Hasty pedigree would cost billions

WASHINGTON —The National Association of Chain Drug Stores, the National Community Pharmacists Association and the Food Marketing Institute are waging a campaign aimed at slowing the drive by the Bush administration and Congress to require electronic pedigrees of every drug sold in U.S. pharmacies.

All three groups issued a joint appeal to the House Energy and Commerce Committee, requesting that members oppose H.R. 5839, the Safeguarding America’s Pharmaceuticals Act of 2008. NACDS vice president of pharmacy regulatory affairs Kevin Nicholson also wrote to the Food and Drug Administration, urging the agency to take a go-slow approach to mandating epedigrees.

“Prescription drug tracking and tracing technologies, although promising, face a number of challenges before they could be considered reliable and acceptable, and could be deployed across the drug distribution system, particularly down to the level of pharmacies and other dispensers,” wrote Nicholson. “Significant industrywide challenges must be addressed and overcome before these technologies can be determined to be an integral and cost-effective part of the prescription drug distribution supply chain.”

In both cases, the groups are asking for a delay to give the retail pharmacy industry and its supplier partners enough time to develop the technology needed to establish the complete movement history of drugs through the supply chain, from point of manufacture to point of dispensing.

Behind the push for electronic pedigrees and track-and-trace technology: fears by lawmakers and agency watchdogs that the nation’s prescription drug distribution system isn’t secure enough against the threat of counterfeit or tainted drugs, which could enter the supply chain through the gray market or other sources.

NACDS, NCPA and FMI noted that they agree with the need to monitor the nation’s drug supply, but said a headlong rush to mandate track-and-trace technology and drug pedigrees is the wrong approach.

“While we appreciate that the sponsors of H.R. 5839 share our goal of further strengthening the prescription drug supply chain, we would ask that you withhold your support from the legislation,” the jointly written letter read. “The bill contains several commendable elements, but it would also mandate an unproven, disruptive and costly … requirement that would severely interfere with pharmacies’ ability to effectively provide vital prescription medicines and healthcare products and services.”

Indeed, the costs for retail pharmacies to comply with track-and-trace mandates using current technologies—which would require multiple systems for reading radio frequency identification tags or 2-D bar codes on all drug packages—would be staggering, Nicholson warned. “The estimated costs for just retail pharmacies to comply would be tens of thousands of dollars per pharmacy and in excess of $1.6 billion,” he wrote.

In his six-page appeal to the FDA, Nicholson noted that new technologies like RFID for tracing and tracking the movement of prescription medicines are still in “a nascent state” and that challenges remain as the industry pursues a common standard for RFID tags, tag readers, signal frequency and other issues.

Among the other hurdles: developing a reliable method for identifying products with a designation that contains all appropriate information; the use of different emerging frequencies used in RFID tags, and the multiple readers that would be needed for each; the unknown impact of radio frequency energy on biologics; and the impacts on existing relationships between trading partners, according to NACDS.