The Pharmaceutical Distribution Security Alliance (PDSA) has succeeded in bringing together several manufacturers, wholesalers, and pharmacy chains in support of a federal law automating pharmaceutical tracking. Its proposed RxTEC Act would replace the “pedigree” requirements of the Prescription Drug Marketing Act as well as any state laws with a uniform federal standard that “would serve as a stepping stone/interim approach to supply chain security,” explained Vince Ventimiglia, counsel with Faegre Baker Daniels, who spoke before the California State Board of Pharmacy’s E-Pedigree Enforcement Committee (CA BoP) in March.
Elizabeth Gallenagh, vice president, government affairs and general counsel, Healthcare Distribution Management Association (HDMA), later told PMP News Senior Editor David Vaczek that “this is the first time that true consensus has occurred with all the stakeholders in terms of a proactive approach to pedigree at the federal level.” Read here for more details on the Pharmaceutical Traceability Enhancement Code (RxTEC) Act.
But what about California? Will the state with the most far-reaching pedigree law see RxTEC as satisfying the original intent of that law, which is to add item-level visibility anywhere, any time in the supply chain?
PDSA members who had joined Ventimiglia before the CA BoP stated that under RxTEC, serial numbers would be called for, but tracking would begin at the lot level only.
This did not appear to sit well with the CA BoP or even FDA, which spoke later.
PDSA representatives stated that the serial number would serve as “a forensic tool,” but all products would be “tracked at the lot level and suspect products would be dealt with at the serial number level.” There would be no mandate for dispensers to check serial numbers.
It is cost prohibitive to scan each bottle, someone stated.
CA BoP members asked the following questions: Lots are currently broken up, so how would someone be able to identify where individuals are under RxTEC? What if someone counterfeits serialized items and their lot number checks out? No one would be able to catch that the serial numbers have been duplicated if the lot number passes and no one is prompted to check the serial number.
FDA’s Connie Jung, acting associate director for policy and communications, CDER, later argued that “full track and trace should apply to all stakeholders.” In addition, “there must be some form of authentication of the number and who sold and received that product. Track and trace will enable us to detect bad products so much more quickly than we can now.”
“We have got to have serialization at the unit level,” she later said. “Every time that product changes hands, that product must be tracked and authenticated and the data captured in a track and trace database.” FDA is not yet sure whether that database would be centralized, semicentralized, or decentralized, but the “SNI would point to the database,” Jung said.
“We have concerns about the value of tracking lots,” she added. “If no one is checking the serial number, [a duplicate number] will go undetected.”
PDSA and its supporters, which include PhRMA and the Generic Pharmaceutical Association and many of their supply chain partners (pharmacies and distributors), should be commended for building consensus for a safer supply chain. However, some argue that item-level track and trace would bring about the visibility needed to eliminate the gray areas of the supply chain.
But many in the industry continue to push back on item-level track and trace. One drug company sitting with PDSA said that it would take three years to implement new technology on its lines.
It is now up to Congress to determine how to secure the supply chain. FDA has been saying for some time that it lacks authority to require item-level track and trace. Will Congress grant the agency the authority it seeks, or will it favor PDSA’s proposal?