Washington, D.C., May 27, 2020 – The Partnership for DSCSA Governance (PDG) (https://dscsagovernance.org/) has concluded its governance pilot under the FDA DSCSA Pilot Project Program. In doing so it has successfully demonstrated that pharmaceutical trading partners can collectively and collaboratively govern the Drug Supply Chain Security Act (DSCSA) interoperability environment as needed to support industry’s successful implementation.
Under the DSCSA Pilot Project Program, authorized by the DSCSA, FDA worked with selected participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. Initially proposed by the Pharmaceutical Distribution Security Alliance (PDSA) and later transferred to PDG upon its formation, the governance Pilot was intended to test the governance structure established under PDG. A use case related to confirmation of the authorized status of trading partners was selected for the purpose of testing the governance structure and functionality.
Over the course of several months, PDG members engaged in a robust discussion of the business requirements expected to be implemented for compliance with the DSCSA obligation to engage only with authorized trading partners. This process identified valuable, incremental recommended adjustments in the governance process, such as changes in voting processes to appropriately balance the speed of discussion with ample discussion.
Overall, the Pilot Project‘s evaluation of the established PDG structure and governance systems showed 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. Most important, it demonstrated that PDG has been successful in abiding by the four key principles of governance:
- All supply chain sectors should work collaboratively to establish efficient, viable, and effective systems and processes to protect patients through compliance with the DSCSA 2023 requirements.
- 2023 system architectures should be governed by trading partners through a balanced, independent, sector-neutral legal entity.
- The governance body’s activities should support interoperable exchange, interoperable verification, and interoperable tracing, as required by the DSCSA.
- Rules for membership and use should incent participation.
As documented in PDG’s final report submitted to FDA, a variety of governance metrics were established at the outset of the pilot for formal evaluation of 11 governance processes and PDG structural elements. A full analysis of those metrics was included in the Final Report, which PDG intends to make public soon.
”I am impressed and encouraged by PDG’s ability to bring together trading partners and technical experts of all sectors and sizes to meaningfully move interoperability forward. The Pilot
Project has demonstrated the ability of PDG to foster cross-sector collaboration in a balanced and unbiased way. We continue to welcome a diversity of voices at the PDG table,” said Max Peoples, Chair of the PDG Board of Directors, affiliated with Uptown Pharmacy.
“The PDG pilot was critical in proving out the success of the PDG structures and processes for industry governance on interoperability under the DSCSA. The pilot also made important progress around how to operationalize the DSCSA requirement to engage only with authorized trading partners, which will be leveraged in PDG’s ongoing work to develop an Interoperability Blueprint by the end of 2020,” added Brian Lee, Chair of PDG Interoperability Committee, affiliated with Bristol Myers Squibb.
PDG is an industry governance body to support interoperability as required by the Drug Supply Chain Security Act (DSCSA). It has been developed collaboratively and launched by dozens of stakeholders throughout the supply chain. Since forming in late-2019, the governance body has quickly gained support from throughout the supply chain, including authorized manufacturers, repackagers, wholesalers, third-party logistics providers, and dispensers, as well as leading industry trade associations and technical experts.
For more information, or to learn more about PDG membership, visit https://dscsagovernance.org.