PDSA Vision for Phase II
The Pharmaceutical Distribution Security Alliance (PDSA) has released “A Proposal: Governance for DSCSA Phase II Interoperability,” the first in a series of White Papers. Through this series of papers, PDSA seeks to stimulate and advance the stakeholder dialogue related to, and development of, a shared vision for Phase II of the Drug Supply Chain Security Act (DSCSA).
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 executing the vision set out in this White Paper. PDSA is publishing this white paper as a well-thought-out starting point for consideration by stakeholders broadly and, ultimately, formation by a diverse set of stakeholders. Although PDSA hopes this proposal will stimulate action toward establishment of a governance body, PDSA does not intend to act as the governance body. It is recognized that revisions to the structure may be needed in order to develop the breadth of stakeholder support needed to ultimately establish the governance body.
As noted above, we intend this first White Paper to serve as a thought piece to stimulate industry conversation and dialogue. We encourage broad stakeholder feedback on the White Paper by sending your suggestions and edits to PDSA@leavittpartners.com. PDSA does not intend to independently evaluate the feedback it receives or reissue a revised White Paper but will compile the feedback and make it available to workshop participants and the future Governance Body.
In addition, a public workshop will be held on May 1, 2019 for industry stakeholders to discuss the broader governance structure and concept. The workshop is open to all interested stakeholders free of charge.
PDSA hosted an informational webinar on April 2, 2019 to introduce the white paper and discuss the content.
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.
PDSA played a critical role in helping develop and enact federal legislation (the Drug Supply Chain Security Act) which protects patient safety and ensures security of the drug supply chain, through a single national uniform system for serializing and tracing pharmaceuticals. PDSA now works with congressional policy makers and the federal Food and Drug Administration (FDA) to clarify and implement this new system and to address other related issues of importance to the pharmaceutical distribution supply chain.
Members of PDSA include leading brand and generic biologic and pharmaceutical manufacturers, primary and secondary wholesale distributors, pharmacies, and third-party logistics providers as well as leading trade associations representing the interest of these stakeholders.
PDSA leaders explain the recently enacted Drug Quality and Security Act and the process toward implementing a single, uniform and national pharmaceutical supply chain solution.
PDSA leaders review the Drug Quality and Security Act, offer a brief history of U.S. pharmaceutical distribution, and detail “next steps” toward a single, uniform and national pharmaceutical supply chain solution.