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Pharmaceutical Distribution Security Alliance Releases Proposal for Governance of DSCSA Interoperability
Washington, D.C., March 25, 2019 — The Pharmaceutical Distribution Security Alliance (PDSA), a coalition of more than 25 pharmacies, distributors, logistics operators, manufacturers, and associations, committed to strengthening the nation’s pharmaceutical distribution supply chain through implementation of the Drug Supply Chain Security Act (DSCSA), has released a proposal for Governance of DSCSA Phase II Interoperability. The proposal is available at https://pdsaonline.org/white-paper-request/.
The DSCSA mandates the development and implementation of systems and processes for the “interoperable, electronic tracing of [pharmaceutical] product at the package level” no later than November 27, 2023. In order to reach that milestone efficiently and effectively, it is critical that stakeholders, including industry and FDA, have a shared vision for interoperability. Stakeholders throughout the supply chain have broadly recognized that an independent, balanced, sector-neutral governance body is important to guide or advance the coordination required by DSCSA.
Today, PDSA is releasing “A Proposal: Governance for DSCSA Phase II Interoperability,” a white paper that is the first in a series of papers with the purpose of stimulating and advancing the stakeholder dialogue related to interoperability. Specifically, this paper sets forth a proposal for one possible structure for the establishment of an independent, balanced, sector-neutral governance body and the functions it would be anticipated to perform in support of interoperability. PDSA is publishing this white paper as a well-thought-out starting point for consideration by stakeholders broadly with the hope that it will support a diverse set of stakeholders—including non-PDSA members—in forming a governance body.
To further support stakeholder engagement and dialogue to advance the development of independent, balanced, sector-neutral governance, PDSA will host a webinar discussing its governance proposal on April 2nd, @ 1:00 – 2:00 P.M ET. Additionally, a stakeholder workshop to discuss and develop a broadly supported governance organization will be held on May 1st in Washington, DC. Both events are open to all interested stakeholders. For additional information or to register, visit www.PDSAonline.org or contact PDSA@leavittpartners.com.
PDSA Member Quotes:
“Genentech makes medicines for some of the world’s most serious and life-threatening diseases, and protecting patient safety at each step of the supply chain is critical. The DSCSA was passed with the goal of implementing a uniform, national pharmaceutical traceability system that would protect patients from counterfeit or substandard medications. Successful implementation of interoperability will require engagement across the entire pharmaceutical supply chain. We believe that the establishment of an independent governance body to address the needs and concerns of all stakeholders through engagement and leadership is imperative,” says Marc Watrous, Senior Vice President, Managed Care and Customer Operations, Genentech.
“As we prepare for an interoperable solution by 2023, the DSCSA requires a level of collaboration across the supply chain that was not previously needed. What has changed? The idea that DSCSA interoperability may require more complex solutions than simply trading partner-to-trading partner connections; instead, for example, authorized trading partners may be connected to people with whom they do not otherwise have direct relationships. How do we manage or govern that? Our collective work in pursuit of compliance with the DSCSA requirement for verification of salable returns has highlighted the critical need for a formal cross-sector governance body as we transition to unit-level interoperability. A governance entity such as the one being proposed today by PDSA is essential to advance the statutory requirements through a neutral body, and drive the discussion and process forward,” said Matt Sample, Vice President, Manufacturer Operations, Amerisource Bergen.
The Pharmaceutical Distribution Security Alliance is a multi-stakeholder and interdisciplinary initiative. Membership spans the entire spectrum of the U.S. pharmaceutical distribution system, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. More than 30 companies are formal members of PDSA, while many other external stakeholders provide additional policy and technical support. For more information, visit: https://pdsaonline.org/.