A bi-partisan group from the US Senate Health, Education, Labor and Pensions Committee has issued a draft version of a bill that is designed to bolster the pharmaceutical supply chain. The move comes six months after they released a so-called draft discussion in hopes of gaining a consensus..
As we reported previously, the effort reflects ongoing disagreement over the steps needed to create a system that can thwart distribution of counterfeit or adulterated medicines. A key problem has been a long-standing lack of agreements among drugmakers, wholesalers and pharmacies about an approach.
These disagreements prevented a so-called track-and-trace provision from being included in the FDA Safety and Innovation Act that was passed by Congress last year. Track-and-trace refers to a method of following drugs through the supply chain.
The move, as we wrote last year, is designed to implement a uniform system that would allow each player to follow each shipment in the supply chain, but would require investment to purchase equipment, such as scanners for warehouses, trucks and pharmacies to read bar codes placed on each 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. But only California has passed a law that requires a universal standard for track-and-trace technology at the unit level (see here, here and here).
But a national system is lacking and since the California law goes into effect in 2015, drugmakers and wholesalers fear that other states may follow suit in the interim, creating an unwieldy patchwork of regulations across the country that would increase costs. And Congress worries such a development would not improve oversight and safety.
"Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug-store shelves," says Michael Bennet, a Colorado Democrat in a statement (read here).
"In fact, right now, we know more from a bar code on a gallon of milk than from a bar code on a bottle of pills, which could mean the difference between life and death… This draft legislation establishes a uniform, national drug traceability system that improves the security and safety" of the supply chain.
Of course, the legislation is only a draft, so a final version has yet to emerge. For now, though, the proposed bill suggests the parties are closer to agreement. For instance, the document contains the earlier reference to creating a form of FDA licensure for wholesalers, as well as third-party logistics providers, which do not take ownership of products, but facilitate shipments.
Drugmakers would have to serialize nearly all medicines; serial numbers and National Distribution Codes would be encoded; and drugmakers and repackagers would be required to create a database of all serial numbers they produce. There is also a definition of transaction history and reference to a transaction statement that each seller must provide each buyer along the transaction chain.
Meanwhile, the FDA would be required to conduct at least one pilot program of a full unit-level track-and-trace system with the industry. And later, the agency may propose a system to replace the initial transaction history. This is actually another way of saying a pedigree program (here is the draft legislation) .
The legislation would settle some unresolved policy questions that would be implemented beginning in four years and completely 10 years after enactment, says Allan Coukell, director of medical programs at the Pew Charitable Trust, who has been involved in efforts to bolster the supply chain. "It immediately pre-empts all state drug pedigree laws, replacing them with a system of tracking and information sharing that would evolve over time. It includes all supply chain stakeholders – chiefly manufacturers, wholesalers and dispensers, but also repackagers and third-party logistics providers – but creates the potential to exempt pharmacies down the road, depending on an assessment by the Secretary of Health & Human Services."
The draft was met with caution by the Pharmaceutical Distribution Security Alliance, a coalition of more than 25 drugmakers, wholesalers and pharmacies, which floated a separate proposal for a unit-level tracking system, but lacked a mandate, putting the group at odds with others in the industry.
The PDSA" looks forward to thoroughly reviewing this draft and to working with lawmakers and other stakeholders to protect the health of patients and consumers by further safeguarding the pharmaceutical distribution supply chain."