Stakeholders respond to FDA's track-and-trace proposals

The US Food and Drug Administration's plans to develop a track-and-trace system for pharmaceuticals received comments from eight organisations by the April 16 deadline, from a mix of stakeholders in the supply chain.

The FDA sought comments to help it develop the system attributes for a track-and-trace system in the wake of a public hearing on the topic held February 15-16. The proposal extends from the agency's prior work in developing a standardised numerical identifier (SNI) for each pack, which would effectively be a serialised National Drug Code (NDC).

On the whole, comments centred on interoperability and coding standards, data management considerations, and issues relating to authentication, currently defined by the FDA as:

"Verifying that an SNI is a valid number for the package with which it is associated. It also involves verifying that the package was sold, purchased, traded, delivered, handled, stored, brokered by, or otherwise transferred from legitimate supply chain participants, and confirming that there are no discrepancies in the distribution history."

The overall aim of the track-and-trace scheme is to further the agency’s goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.

AstraZeneca

Setting out the stall of a pharmaceutical manufacturer, AstraZeneca says that it is important that a successful track-and-trace system should improve supply chain security, improve patient safety and be "harmonised with global approaches and non-proprietary standards," as well as being "fully interoperable with supply chain partner systems."

Any system should be implemented in a phased fashion to avoid hindering patient access to medicines, and the company makes a case for a point-of-dispense verification model similar to that used in the pilot project run by European drug industry group EFPIA; in other words one which does not require verification at intermediate points in the supply chain, at least in the first instance.

"AstraZeneca believes that establishing real-time verification at the point of dispense can be accomplished in the near-term by serialising each trade pack using available robust 2D data matrix barcode technology while leveraging existing standards," according to the company's comments, which are signed by David Buynak, who heads its North American serialisation programme.

The company says it does not support extending the track-and-trace system beyond point-of-dispense verification of unit doses - for example by linking unit packs with cases or pallets (aggregation) or developing a full electronic pedigree with each stage in the supply chain recorded and passed on to the next.

"Adding aggregation alone doubles the implementation costs and requires significant business processes change for all supply partners," says AstraZeneca. "The value proposition and timing for building on of any new track and trace elements should be agreed amongst supply chain partners…based upon supply chain risk and technological capabilities."
 
Using this approach, a working system could be up and running by 2016, meeting the California Board of Pharmacy's deadline for manufacturer compliance. The FDA should develop its own pilot study involving all supply chain partners and undertake periodic assessments to evaluate its progress and impact on the supply chain, according to AstraZeneca.

The potential complexity of a track-and-trace system is the drugmaker's number one concern, followed by the lack of federal legislation to pre-empt and unify state-level legislation, such as California's requirement for 100 per cent serialisation and ePedigree by 2016.

AstraZeneca's other major concern is about data visibility and ownership. It points out that "a track-and-trace system must maintain the proprietary nature of each entity's data by appropriate security controls to limit data entry and access to relevant authorised parties."

Meanwhile, other issues not raised at the FDA's meeting include the ratified non-proprietary standards and technologies, limited capacity among serialisation vendor companies to carry out implementation across the USA given similar initiatives elsewhere in the world, and a lack of "necessary FDA regulations" on critical issues such as "labelling submissions, validation activities and stability studies."

AmerisourceBergen

Also commenting on the proposals is AmerisourceBergen, one of the world's biggest pharmaceutical wholesalers and distributors. The company focuses in three major points in its submission, namely the use of the term 'authentication', issues surrounding data management and use of data standards.

On authentication, AmerisourceBergen maintains that the 'package' carrying the proposed SNI for verification should not only to unit packs supplied by the manufacturer of the drug or a repackager, and also "a full case, a mixed case, or a pallet with an SNI that is applied by an appropriately licensed company in the supply chain." The aim is to allow parties in the supply chain to carry out a single scan of a pallet or case SNI, and infer the SNIs of the unit packs contained within it. This would "maintain the current level of efficiency and fulfilment that exists in the supply chain," it contends.

In addition, verification of the package's distribution history should be accomplished by verifying ownership if one trading partner back, while disposition and validity of SNIs should be based on a decentralised track-and-trace system to which all trading partners have access.

The need for decentralised data system - with communication hubs allowing trading partners to share or not share data as appropriate - lies at the heart of AmerisourceBergen's comments on data management. Trading partners in the supply chain should be able to query distribution history for just one single SNI for themselves, or for an inquiring regulator, it adds.

The communication hub (or registry) is a fundamental piece in the puzzle, it argues, and the FDA should encourage industry to begin development of this as soon as possible because "little can be done from a data exchange perspective until this is available for testing and pilots."

Finally, the wholesaler makes a plea for the adoption of GS1 standards for the track-and-trace system as these are already applied across the pharmaceutical industry for barcodes, etc. However, it says further refinement is needed of the GS1 standards "to provide more specificity for the number of characters and formatting to be used in the NDC portion of the SNI as well as the serial number portion."

It also says that further clarification is needed on GS1's Global Location Number (GLN), which is used to identify the location and identity of trading partners in the supply chain.

The comments are signed by Shay Reid, vice president, operations, at AmerisourceBergen.

UPS

From the shipping and freight services industry, UPS Supply Chain Solutions contends that the FDA should not mandate any specific technology for track-and-trace, rather define the requirements, and that industry stakeholders should develop interoperable technology themselves.  The goal should be a "Federal standardised system or data repository that allows interoperability related to data format, data communications and data interpretation around inputs of the same format and structure."

The company also wants the terminology in the proposal updated to include "third-party logistics providers (3PLs), carriers, warehouses, brokers and other intermediaries," in other worlds parties outside the traditional pharma distribution scheme but which are playing an increasing role in the supply chain.

Finally, UPS would like the FDA to develop a Federal Distribution License alongside the track-and-trace system that would pre-empt state licensing schemes and help accommodate the changing nature of the pharmaceutical supply chain. "The existing process of facility licensing fails to leverage today's technology advancements, adds unnecessary costs to the healthcare supply chain, and creates confusion," it claims.

UPS' comments were signed by Timothy Bishop, the company's quality assurance senior manager.

Other comments

Jubilant Hollister-Stier, a manufacturer and marketer of allergenic extracts, and the Allergen Product Manufacturer's Association argue in their comments that allergenic extracts should be exempted from any track-and-trace requirements. Among the reasons given are that these products are generally sold directly to the end-user (physician), with only around 2 per cent passing through wholesalers or secondary distributors. These products are already exempted from bar code regulations on similar grounds. "The allergenic product industry … would face significantly higher technical, logistical and economic barriers in meeting any electronic track and trace technology … than would large mainline pharmaceutical manufacturers," they claim.

The National Council for Prescription Drug Programs (NCPDP), a healthcare standards development organisation, also backs the need for harmonised coding systems and vocabulary to help communication between trading partners, and says it is important to include a human-readable format. Identifiers used must be able to support uniqueness not only at the unit or product level, but also at the package, case, pallet, tote, and shipping container levels. On the issue of authentication, the NCPDP notes that it is critical that pharmacies - which serve as the gatekeeper of patient safety - understand how to interpret the messages that they receive from the upstream supply chain.

The Healthcare Distribution Management Association (HDMA) maintains in its comments that additional refinement is needed on the definition of 'authentication', which it says is broader than commonly understood in the pharmaceutical supply chain.  It argues against a centralised data management system on the grounds that this will be overly burdensome given anticipated transaction data volumes, and reiterates calls for convergence around GS1 data standards. 

The Pharmaceutical Care Management Association (PCMA), representing US pharmacy benefit manager (PBM) insurers, adds its voice to those calling for a single unified coding standard. It urges the FDA to adopt a data management system and safeguards that limit the ability of supply chain partners to access data for other purposes than verifying a product is legitimate. The party receiving a product should have information only on the preceding party, not others further upstream.  The FDA should consider a phased roll-out, mindful of the complexities and cost of implementation, and consider carefully the needs for mail service pharmacies which have "unique packaging challenges at the supply and dispensing levels."

All the comments can be downloaded via the www.regulations.gov website. Search for docket number FDA-2010-N-0633 with 'Public Submission' as a search filter.