Despite years of debate over the security of the pharmaceutical supply chain, the House and Senate failed to reach an agreement to include a so-called track-and-trade provision for medications in the Prescription Drug User Fee Act legislation that is being debated in Congress. At issue were conflicting efforts to create a national system that would, ideally, thwart distribution of counterfeit or adulterated medications.
The failure reflects a long-standing lack of agreement among the many players – drugmakers, wholesalers and pharmacies – about a suitable approach. A key sticking point is cost. To implement a uniform system that would allow each player to follow each shipment in the supply chain requires an investment to purchase equipment. This would include scanners for warehouses, trucks, and pharmacies to read bar codes placed on every bottle in each lot that is shipped.
More than 30 states have passed laws requiring so-called pedigrees, a reference to steps taken to prove proper possession of medicines along the supply chain. Only California, though, has passed a law that requires a universal standard for track-and trace technology at the unit level (see this, this and this).
However, the California law goes into effect in 2015, raising the prospect that other states may follow suit in the interim. This suggests that a nationwide patchwork of state laws that would require different investments and practices may go into effect. A bi-partisan bill was introduced in the House last fall that largely mirrors the California law (look here). Separately, a coalition of drugmakers, wholesalers and pharmacies known as the Pharmaceutical Distribution Security Alliance floated a similar proposal, although it lacked a mandate for tracking drugs at the unit level (see this and the membership list here).
An amendment to Senate version of PDUFA that would have required a track and trace system had been introduced by Richard Burr, a North Carolina Republican, and Michael Bennett, a Democrat from Colorado (see here), but after a new draft was proposed late last week, lawmakers were unable to obtain agreement from the various parties on how quickly to implement a national system that would track individual units.
The lack of agreement in Congress, however, may have been a blessing in disguise, according to one expert who believes a tougher, nationwide track-and-trace system should be implemented at the unit level. "We had hoped that consensus could be reached, but Congress made the right decision in not preempting California's strong patient protections with a federal proposal that provided no comparable standard," says Allan Coukell, a pharmacist and director of the medical programs at the Pew Health Group, who testified earlier this year at a Congressional hearing on the subject.
For now, though, some say the lack of a national approach will leave the supply chain vulnerable to more incidents such as the counterfeit Avastin episode that occurred earlier this year. The FDA, you may recall, identified nearly two dozen physician practices that purchased fake Avastin from wholesalers, some of which were later traced to various spots around the globe (back story).
"Such a system would have streamlined the current patchwork of state laws and regulations and enhanced the safety and security of the supply chain to the benefit of all patients," John Gray, ceo of the Healthcare Distribution Management Association, a trade group of pharmaceutical and healthcare products wholesalers. "Without a national approach, the industry also faces increased costs to comply with the multiple, conflicting state pedigree laws. In an era of increasing healthcare costs, the inability to achieve cost-effective federal preemption is a disappointment to all players in the healthcare supply chain."
One expert, meanwhile, speculates the void might be filled if the FDA issues a draft guidance for non-binding recommendations that some states could mimic, creating a de facto system. "If there are any new state drug pedigree regulations drawn up at any time in the future, they would be foolish to designate anything other than the FDA non-binding Standardized Numeric Identifier for their unique identifier," wrote consultant Dirk Rogers on his RxTrace blog, noting the agency already issued a draft guidance specifically about SNI. "What the FDA has done is to define a non-binding 'standard' for a unique identifier for drugs that will be applied nationwide, all without needing to make it a federal mandate."
We asked a spokesman for the Pharmaceutical Distribution Security Alliance for a comment last night, but none was forthcoming. We will update you with any reply that we may subsequently receive. [UPDATE: A few hours after we posted, a PDSA spokesman sent us this: "The broad coalition of stakeholders in PDSA supported the committees’ process and believes the discussion draft of June 15th merited support and inclusion within the user fee legislation with only limited modifications. PDSA is disappointed these protections have not been included as part of the PDUFA bill; however, we remain hopeful all parties will continue to work – right now – on this historic effort to protect America’s patients."
pic thx to safemedicines.org