Two days before the Drug Supply Chain Security Act (DSCSA) was signed by then President Obama, I published “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”. Under the heading “Who should organize and start the effort [to organize the industry around solutions to the DSCSA]?”, I wrote:
“I have not been a part of the Pharmaceutical Distribution Security Alliance (PDSA) but it seems like that organization has the right mix of associations and individual companies in its membership, although its original purpose was to pass a Federal serialization and track & trace law through lobbying Congress. Could it be transformed into more of an industry technology mapping organization? I don’t know, but from my outsider’s view it seems like the opportunity is large and this organization seems to have a significant head start. I also know that the member organizations have employees with the necessary business and technical expertise, along with GS1 US, to come to the right conclusions.”
Today, PDSA is publishing two of what will become four documents that are aimed at jumpstarting a very serious discussion in the industry around DSCSA governance. The complete set of documents will eventually include:
- “An Overview: PDSA Vision for Phase II Interoperability and Governance” (published today)
- “White Paper 1: A Proposal: Governance for DSCSA Phase II Interoperability” (published today)
- “White Paper 2: The Interoperable Exchange of Transaction Information and Transaction Statements” (future)
- “White Paper 3: The Interoperable Verification and Tracing of Pharmaceuticals” (future)
I just received copies of the first two documents and it will take me considerable time to review and prepare to comment on these important pieces. As long-time RxTrace readers know, this is what I live for! Thanks PDSA. I am providing this information in today’s essay, but I will withhold my comments until next Monday, April 1st.
I can also let you know that PDSA will hold a webinar at 1pm EDT on April 2nd to discuss the white paper (register for the webinar here), and a stakeholder workshop in Washington DC (and by phone) at 10am-3pm EDT on May 1st (register for the workshop here).
I am hopeful that PDSA papers represent a serious effort that will carry the industry forward to meeting the Enhanced Drug Distribution Security (EDDS) phase of the DSCSA, which is due to start on November 27, 2023. The changes to the way drugs would be distributed in that phase, as envisioned by the DSCSA, will require all stakeholders to operate differently. The differences may seem subtle, but because they require all stakeholders to communicate in an interoperable way, the changes must be planned, implemented, tested and deployed carefully. The industry and the FDA must start figuring out the details many years in advance of the deadline…like, right now.
So I look forward to reading these first two documents and providing you my thoughts next week. By that time, I suggest you read them so you are ready to comment on my essay next week.