The Pharmaceutical Distribution Security Alliance (PDSA) is an interdisciplinary, multi-stakeholder initiative that functions like a cross-industry trade association. Established and coordinated by Leavitt Partners, LLC, a health care intelligence firm in Washington D.C., PDSA’s cause is true to its name: It is a collective committed to safeguarding patients by ensuring that the pharmaceutical supply chain remains as secure as possible.
The Alliance focuses on policy and technical standards for the pharmaceutical industry. Its members span the entire spectrum of the U.S. pharmaceutical distribution system, including manufacturers, wholesalers, pharmacies, third-party logistics providers, and their trade organizations.
PDSA was instrumental in helping to develop and enact the 2013 Drug Supply Chain and Security Act (DSCSA), which calls for a single nationwide system for product serialization and traceability to protect patient safety and ensure security of the drug supply chain. In addition to electronic tracking and tracing of all drugs, it requires any company that wants to sell or trade a pharmaceutical product in the United States to have interoperable communication and coordination. Per the law, no government agency, including the Food and Drug Administration (FDA), will determine or govern the technology or system.
PDSA now works with the FDA and Congressional stakeholders to meet three objectives:
- Understand the DSCSA to identify ambiguities and challenges that require clarification or the development of operational solutions.
- Engage the FDA to ensure regulation is consistent with PDSA objectives and the best reading of DSCSA
- Work with members to identify, develop, and memorialize the cross-sector challenges and needs to move the industry toward unit-level interoperability by 2023
Because DSCSA is so complex and demands transformative change, PDSA and other stakeholders have advocated forming an independent, sector-neutral governance body to guide the interoperability it mandates. With a series of white papers and public meetings, PDSA has begun formulating a vision for this body through the FDA Pilot DSCSA Governance Processes. Although the Alliance does not intend to push into business operations or attempt to issue regulations, according to Eric Marshall, a senior director at Leavitt Partners who advises PDSA, “there is a space in between where there’s going to need to be some alignment.”
Historically, PDSA and its industry partners engaged only their supply chain trading partners. For DSCSA, however, they recognize the key role solution providers will play, not only in the law’s broader traceability efforts, but also as constituents in the governance model. rfxcel, the first solution provider to focus on pharmaceutical supply chain safety and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers, has been asked to participate in the PDSA’s Governance Pilot and provide insight to significant issues, including the structure of the governance body, designing a 2023 technical roadmap, and regulatory direction.
On May 1, 2019, rfxcel participated in the PDSA Governance Workshop and public meeting, which engaged the DSCSA community and provided feedback on what will be necessary to ensure the governance body will be effective and successful. By working with PDSA, rfxcel is fulfilling its mission to be the thought leader in traceability technology and to enable customers to better manage their businesses today and deliver value tomorrow.
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