Introducing the Partnership for DSCSA Governance

In less than a year, the Partnership for DSCSA Governance (PDG) has gone from a concept to fully functional body with 50 members, dedicated to ensuring interoperable medicine tracing in the US supply chain by 2023.

Eric Marshall and Alissa McCaffrey explain the background to the organization, and its plans for the future.

The Partnership for DSCSA Governance (PDG) is a collaborative forum dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the US.

Less than a year ago, PDG was a concept. Conceived in a white paper by a group of supply chain experts, the notion of an independent, balanced, sector-neutral nonprofit industry governance body took shape over the course of 2019 as supply chain members discussed, revised, and coalesced around a model. Today, PDG is a productive governance entity with more than 50 member organizations from throughout the drug supply chain collaborating to make important progress toward the goal of developing a vision for interoperability under the Drug Supply Chain Security Act (DSCSA) in 2023 and beyond.

Efficient implementation of the DSCSA requires an intentional implementation plan that builds toward a shared vision for interoperability. Interoperability, by its very definition, requires coordination and consistency through the supply chain; a supply chain of more than 20,000 different organizations ranging from large, multinational drug manufacturers to mom-and-pop pharmacies.

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PDG provides a balanced, sector-neutral body, operating with clear rules for engagement, where the full range of diverse supply chain entities can come together to plan for 2023 interoperability under the DSCSA. That collaboration has PDG well-positioned to meet its aggressive goal of publishing a consensus, industry-wide implementation plan for interoperable tracing in 2023 at the end of this year.

PDG has already completed a pilot under the Food and Drug Administration (FDA) DSCSA Pilot Project Program, which successfully demonstrated that the PDG governance structure is sound, that PDG members are effectively engaged, and that meaningful progress toward 2023 interoperability can be made within PDG. In addition, the PDG Pilot Work Group was able to provide clear recommendations to the PDG Interoperability Committee on the business requirements for validating Authorized Trading Partner (ATP) status of supply chain entities engaged in interoperable verification and tracing.

Over the next six months, PDG members will continue to collaborate though four work groups designed to create a vision for how the interoperability requirements of the DSCSA will be implemented over the coming three years.

1. The Credentialing and User Authentication Work Group is tackling the complex challenge of defining an approach by which trading partners—manufacturers, wholesalers, and dispensers—will be able to reliably and securely identify their organizations in an electronic environment, a lynchpin to electronic interoperability. This includes both how a trading partner will demonstrate they are duly licensed or registered as required by the law and how will prove their organizational identity.

2. The Serialized TI Exchange Work Group is defining the expectations and requirements needed to exchange transaction serialization data to enable interoperable electronic verification and tracing. Many in industry have long viewed the GS1 Electronic Product Code Information System (EPCIS) standards as the ideal method of exchanging serialized data in the future, but there is significant debate as to how fast and aggressively the EPCIS approach should be advanced. That debate is ongoing and PDG hopes to soon resolve it. The Group will also wrestle with the difficult question of how best to implement aggregation and inference practices to maintain the quality and integrity of supply chain data.

3. The Verification Architectures Work Group is defining the ways in which trading partners can implement the requirement to verify product in an interoperable, secure, and electronic manner. Major tasks for the Work Group include defining the appropriate data sources for verification, developing expectations for management of errors and exceptions, and recognizing or identifying the need for messaging standards to support verification.

4. The Tracing Architectures Work Group is working to develop a sound vision for how industry can retroactively trace the chain of ownership of a drug package through the supply chain. The diversity of trading partners and sheer volume of data—tens of billions of data records distributed across thousands of trading partners—makes this a complex undertaking. Through collaboration, the Work Group is establishing a reliable framework for that activity.

Together, the output of each of these Work Groups will enable PDG to create and publish a consensus-based industry vision for the secure, electronic, interoperable unit-level tracing, verification, data exchange, and reporting, as required under the DSCSA. This vision will not only provide an overarching path to, and key principles for, interoperability, but will define the necessary functional system, process attributes, and rules around governance to assure that the consensus functionality is maintained in a sustainable fashion.

If you would like to get involved in the PDG discussions, you can contact PDG or visit the PDG website for more information: https://dscsagovernance.org/join-now/.

Eric Marshall

Executive Director, Partnership for DSCSA Governance (PDG)

Principal, Leavitt Partners

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Alissa McCaffrey

Manager, Leavitt Partners

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