Stakeholders push lot-level traceability model at committee hearing

Pharma industry groups and other stakeholders have laid out their own proposals for a supply chain security model in front of the US Energy and Commerce Subcommittee on Health, which stops short of a full, item-level pedigree for medicines but would allow lot-level traceability.

The hearing was convened on March 8 to cover a basket of issues related to the latest incarnation of the US Prescription Drug User Fee Act (PDUFA), including downstream supply chain security.

The proposed Pharmaceutical Traceability Enhancement Code (RxTEC) system is the brainchild of the Pharmaceutical Distribution Security Alliance, a coalition of drugmakers, trade organisations, wholesalers, third-party logistics (3PL) providers and pharmacies that is trying to come up with a system that provides effective security but scales down the unit-level pedigree that is required in California's legislation, due to come into effect in 2015.

California's flavour of pedigree would require the entire distribution history and the location of every medicine pack in the supply chain to be determinable at any time. Critics claim this is not only very challenging technically, but also costly to implement and would lead to an increase in medicine prices.

Specifically, the RxTEC model would provide item-level serialization of medicine packs using 2D datamatrix codes - in compliance with the FDA's 2010 guidance on serialized numerical identifiers (SNIs) - and this would allow each item to be associated with a lot numbers and the quantity of units within each lot. 

Traceability would only be applied to the lot level, and rather than providing full chain-of-custody pedigree as per the California model, would identify only the previous and next owner/handler of the shipment.

Shawn Brown, vice president of state affairs at the Generic Pharmaceutical Association (GPhA), told the Committee hearing that the FDA also seems to be backing a California-type track-and-trace system, but also needs the relationship between unit-level serial numbers, case and pallet numbers to be 100 per cent accurate.

"This cannot be achieved," said Brown. "With billions of units moving quickly and efficiently through the supply chain to fill more than 4 billion prescriptions per year, the magnitude and complexity of such a system is not technically feasible."

It is worth pointing out that California's e-Pedigree law does include a provision allowing it to be superseded by federal requirements, and the PDSA is effectively acting as a lobbying group to try to push an alternative model through. And while many other states have passed their own pedigree laws, only California contains the unit-level pedigree provision, and the pharma industry is desperate to avoid having to contend with a disharmonised, patchwork of requirements across the USA.

The GPhA is one of the organisations supporting the PDSA, which also has the backing of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Healthcare Distribution Management Association (HDMA), the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association NCPA).

The NACDS also provided testimony at the hearing, saying that "premature drug 'track and trace' models would unnecessarily increase healthcare costs while imposing burdensome technologies that have not demonstrated an ability to enhance supply chain security." It said it supports the PDSA but is proposing some changes to the RxTEC discussion draft "to address various concerns".

The consortium will likely face a battle to get its model advanced, however, given that it is one of a plethora of proposals trying to ride the PDUFA's shirt tails, while other proposed legislation such as the bipartisan Safeguarding America's Pharmaceuticals Act (HR 3026) is also in the offing. The SAPA was introduced by Congressmen Jim Matheson and Brian Bilbray last September and also calls for an item-level pedigree system (although its notable this bill has been tabled in various forms going back to 2008 and has yet to gain significant traction).

No routine authentication step?

There are also those who believe the RxTEC system is flawed because it does not include a mandatory medicine verification step at the point-of-dispensing, in contrast for example to the European Stakeholder Model proposed by industry, wholesaler and pharmacy groups in Europe and the eTACT model being developed by the European Directorate for the Quality of Medicines and Healthcare (EDQM).

Rather, the system would rely on lot traceability to prevent counterfeit, diverted, stolen or otherwise illegal product entering the supply chain, while the unit-level serialisation would provide the granularity to allow regulatory and enforcement bodies to validate the serial number of suspect product.

That means that it provides a way to track back potentially harmful medicines but would not necessarily prevent exposure to them in the first place. Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research (CDER), told the hearing that to adequately protect the supply chain, a tracking system must be able to identify an individual product in real time as it moves through the supply chain.

The PDSA maintains that RxTEC is a practical, interim position that would improve security without being too onerous or costly to implement. That said however, RxTEC would also operate to longer timelines, with a provisional compliance date of 2020, and this may not sit well with US lawmakers in light of the high-profile case of counterfeit copies of Roche's cancer drug Avastin (bevacizumab) reaching patients in recent weeks.

More than just traceability

Meanwhile the PDSA proposal - provisionally called the Pharmaceutical Traceability Enhancement Code (RxTEC) Act of 2012 - also includes a number of other elements beyond the traceability model, including new and standardised requirements for licensing of wholesale distributors, 3PL providers, manufacturers and repackagers.

Also covered are new provisions for electronic labelling used in lieu of paper prescribing information (outserts), new enforcement tools to tackle rogue online pharmacies, increased penalties for those found guilty of counterfeit drugs up to a maximum of 20 years in prison or life if a fake is shown to have been directly responsible for the death of a consumer.

"The RxTEC system is a national supply chain stakeholder consensus model that will replace the patchwork of inconsistent state laws, while increasing patient safety and enhancing our ability to identify and prevent the introduction of suspect product," asserted Brown at the hearing.

"We urge the inclusion of the proposal in the user fee package to accomplish these goals."