House drug traceability bill makes stride forward

For the first time in more than 15 years, a medicines traceability bill has gone forward to be considered by the full House of Representatives in the US.

The House Committee on Energy and Commerce approved the Safeguarding America's Pharmaceuticals Act of 2013 (H.R. 1919) this week (May 15), based on a raft of technical amendments from the original version that was tabled towards the end of April.

The bill - in common with a Senate traceability bill also introduced last month - would introduce a lot-level pedigree model for prescription drugs, with organisations handling medicines responsible (broadly) for keeping track of shipments up and down the supply chain from manufacturer to pharmacist.

Lot-level traceability is commonly employed in the food industry. However, it has come under fire almost immediately as a solution for pharma on the grounds that it does not go far enough to secure the supply chain, and in particular for not setting a process in motion to extend the measures to include unit-level traceability of each medicine pack, as is mandated in the California electronic pedigree legislation which is due to come into effect in 2015.

The approach is markedly different from the end-to-end model being discussed in Europe and already implemented in other countries such as Turkey. Here the emphasis is on unit-level traceability, with packs checked on entering the supply chain after on dispensing to patients - without the increased burden of monitoring transactions in between.

It is also different from the Senate bill, which starts out with lot-based tracking model as an easier option to get rolling but has a 10-year deadline for introducing unit-level pedigree for most prescription medicines. Any reconciled House and Senate bill would of course pre-empt California's plans and other state requirements.

The thorniest section of the bill is Section 3 on Enhanced Drug Distribution Security, which calls for a series of pilot projects, public meetings and feasibility studies to gauge whether actors in the medicines supply chain are able to "enhance the safety and security of the pharmaceutical distribution supply chain" beyond the current proposal.

Either way, pack-level traceability could not be mandated until after the FDA issues proposed regulations in 2027, more than a decade after California's requirements are due, and the bill sets no timeline for such regulations to be adopted.

It is notable that an attempt by Democrat Rep. Frank Pallone to require a 10-year deadline for unit-level traceability via an amendment to the bill was blocked by a vote of 19 to 28, along with three other proposed amendments.

Efforts to tag a lot-level traceability amendment called RxTEC to the Prescription Drug User Fee Act (PDUFA) negotiations last year ended in failure, with observers suggesting a key sticking point was that the proposals were not considered robust enough to meet the primary objective of protecting patients for counterfeit and otherwise illicit medicines.

The California Board of Pharmacy had not responded publicly to H.R. 1919 at the time of writing, but has already indicated it believes the Senate bill is a "significant step backward from the California model for electronic pedigree/track-and-trace," and specifically objects to the "additional delay that is built into the various stages of the proposal", including the implementation if tracking and validating shipments at the saleable unit level.

Last year, the CBP said that lot level traceability via data carrier as detailed in the RxTEC proposal "would be entirely duplicative of the human-readable lot numbers that are already printed on individual units".

Give that the House bill seems be weaker than the Senate draft, CBP support for the current draft is unlikely. A number of commentators suggest both House and Senate proposals are something of a retrograde step as many drugmakers and wholesale distributors indicated five years ago they were prepared to comply with California's ePedigree requirements in return for its delay until 2015.

In fact, most large pharma companies are already well on the way to implementing unit-level serialisation to meet requirements outside the US, so a lot-level approach could undermine the perception of the US supply chain relative to its overseas peers.

Smaller drugmakers are however not so well-prepared and may welcome an extension to the deadline for action, although this is at odds with the bill's overarching ambition to shore up patient safety.

Meanwhile, what is the US Food and Drug Administration doing, aside from providing guidance on broad principles such as formats for serialised numerical identifiers (SNIs)?

Many believe the FDA is adopting a wait-and-see policy on this issue, seeing whether the California proposals will be feasible and accepted and - if so - adopting the scheme or at least a modified version at a federal level.