Regulatory Guidance

FDA DSCSA Pilot Project Program

A question and answer with John Jacey, a leader on TraceLink’s Digitalization Strategy team

Announced by the FDA in February, the DSCSA Pilot Project Program is a 2019 effort to explore business processes and supporting models technologies that will enhance the tracing and verification of pharmaceutical products in the U.S. supply chain. 

Q: For those not up to speed, could you share more insight into the DSCSA Pilot Project Program?

A: Under the Drug Supply Chain Security Act (DSCSA) the Food and Drug Administration (FDA) is charged with working across the Life Sciences eco-system to comply with the law.

To that end, the FDA initiated the DSCSA Pilot Program to prompt the industry to collaborate to develop the key attributes of various aspects of piloting end-to-end systems capable of meeting the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain.

When the FDA called for pilot project participants, it was seeking representatives of the pharmaceutical distribution supply chain including contract manufacturers, pharmaceutical manufacturers, wholesale distributors, repackagers, returns processors, logistics partners, technology solution providers, and dispensers.

Q: Can you discuss TraceLink’s pilot?

A: TraceLink’s submission to the FDA pilot program included two workstreams: an interoperable blockchain network solution, and a solution to digitally manage drug recalls across a digital supply network.

Both workstreams bring together diverse stakeholders from across the entire supply chain and in collaboration with regulators, aims to provide insight to enhance patient safety, while addressing tough business and compliance challenges through network connectivity and innovative software solutions.

Q: Interoperability is a central theme of the program; overall what are the FDA’s goals and who are they enlisting from industry to help?

A: The DSCSA specifies that for 2023, all participants need to have systems and processes in place to enable the electronic interoperable tracing of medicines at the package level to support suspect product investigation.  We also see a very logical opportunity to improve the highly fragmented and manual recalls process with an eye toward leveraging the combination of a Network, lot level data, and eventually serialized data.

With respect to interoperability, regulators and participants recognize that the U.S. pharmaceutical supply chain is highly diverse in scale and size, and therefore, operating systems of the supply chain must embrace this; the focus can’t just be on what serves the most advanced companies—it has to include everybody involved.

Interoperability and the use of open interoperable standards is crucial. Our workgroup is approaching this with the assumption that any future solution must support interoperability across blockchain and non-blockchain networks, unlike other industry initiatives that require the unlikely use of a single blockchain system throughout the industry. For Digital Recalls, we will be examining interoperability and integration with a variety of supporting systems where information about lot and serialized identifiers reside with the goal of quickly removing recalled product from the market.

Another important consideration related to interoperability is how to govern the verification of participants on an interoperable eco-system and how to manage data ownership and permissions while being mindful of trade agreements. All of these considerations will be addresses in both of our workstreams.

Q: TraceLink successfully submitted applications for two of the program’s key work streams: What were they and why do you think they resonated with regulators? 

A: TraceLink will bring together all stakeholders from the supply chain to evaluate how blockchain can be used to help companies meet DSCSA transaction information gathering requirements.

This workstream will not necessarily focus on a technology solution, although we will leverage TraceLink’s blockchain solution, Trace Histories as one of the tools the industry can use to develop a blueprint for an open, interoperable network to achieve full unit level traceability across the supply chain. We will be initially focusing on topics such as interoperability, data ownership and permissioning, governance, credentialing of Network participants and data with the goal of supporting suspect product investigations across a distributed supply network. We have a current hypothesis that a distributed ledger approach will enable safe and secure information exchange between authorized partners via a unique “gather upon request” model.

Unlike other industry initiatives calling to adopt a single common blockchain system for the industry, our working model is targeted to support interoperability across blockchain and non-blockchain networks. In the US, we’re not limited to only one set of standards, we’re collaborating to find commonly adopted, commonly used technologies and platforms. We then plan to share this understanding to create common solutions and best practice implementation blueprints.

The second workstream for digital recalls tackles the highly fragmented and manual process of drug recalls.  The FDA very clearly stated in its vision for 2023 that it didn’t want the focus just to be on compliance, it wanted to prompt the industry to look at all the tools, processes and technology being developed and explore other supply chain and patient benefits that may be achieved. One big area of focus is on product recalls – it’s a safety issue and a huge cost and efficiency drain on the pharmaceutical supply chain.

While each individual stakeholder in the supply chain may have good current, but manual, processes, the recalls process really is fragmented and difficult to execute across the industry.  There are duplicative efforts and a lot of paper processes.  Like Trace Histories, we will be exploring topics of governance, integration, interoperability, data ownership and visibility, but we will be also considering what can be accomplished immediately using a Network approach to recalls communications and leveraging lot level Transaction History data.  We will also be taking a holistic view of what the recall process will look like in a fully serialized market in 2023 and beyond. 

Q: Who is participating in the program besides TraceLink? What collectively, do you think the collaborators FDA has chosen will bring to the table and the project?

A: Unique to TraceLink’s pilot project is the inclusion of a very diverse set of industry participants including contract manufacturers (both recalls and suspect product investigations could impact upstream partners), large pharmaceutical manufacturers, biopharmaceutical companies, repackagers, wholesale distributors, major retail pharmacy chains, diversified healthcare systems, third-party logistics providers and returns processors.  In terms of diversity within the sectors, we have some of the largest manufacturers, wholesalers and retail chain drug participants, yet we also have small biotech and regional and specialty wholesale, dispensers, and hospital groups joining us to ensure that all voices are heard.

These companies, many of whom are our customers, represent the scope, complexities, and operational use cases from all segments of the supply chain. Combining insights from these leading companies with TraceLink’s digital supply network will garner compelling information that will contribute to the innovation, security, and interoperability of the supply chain and improve patient safety

Q: The DSCSA pilot project program is intended to help identify and evaluate the most efficient processes and technologies to assure compliance accurately and economically. What ultimately do you see as the value the subsequent report will deliver and what do you think its impact will be on the pharma supply chain? 

A: TraceLink feels the whole effort is going to gather a wealth of knowledge specific to all stakeholders that cohesively will address industry challenges that need to be addressed before the vision of DSCSA 2023 can be realized.  

With the Trace Histories workstream, we will identify how the industry can meet the compliance aspects of the law within the context of established and emerging trade structures and ensure that all stakeholders are verified, yet also able to protect their data where appropriate.

In our Digital Recalls workstream, we believe that we can have a near term impact on the recalls process by vastly improving recalls communication and tracking via the TraceLink network, which already has over 275,000 participants.  Based on our stakeholder discussions to date, we understand the need for better means of communication, more accurate identification where recalled product is in the supply chain, and ultimately the need to get product off the shelves faster for patient safety.  

The objectives of the FDA pilot program align closely with TraceLink’s mission of developing new solutions that will drive visibility and collaboration, resulting in not only increased security and safety, but ultimately, patient safety. As for the industry and its supply chain security goals, the program lays a very strong foundation to tackle the many pressing issues that the supply chain faces today as well as opens the door to new digitalization initiatives that leverage  collective investments in serialization.

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