Following through on its commitment to FDA to conduct a meaningful pilot project, the Partnership for DSCSA Governance (PDG) announced that it had successfully developed a consensus agreement on how to define the status of an “authorized trading partner” (ATP) in the context of the evolving electronic systems to share product data and status. To an outsider, this might seem to be a fairly trivial accomplishment—basically, a few definitions and qualifying statements—but the larger goal is vitally important: how to bring the various parts of the pharma supply chain together so that there is consensus on how information is to be shared. The ATP information is a use case for the overall governance process.
The FDA pilot program, which kicked off about a year ago, involved the selection of projects by 20 organizations (private companies, hospitals, research organizations and—in the case of PDG—a few people who had worked with a predecessor organization, the Pharmaceutical Distribution Security Alliance). Reports have been filed with FDA, and there is a generalized expectation that FDA will collate and summarize the reports, some of which involve running tests of actual exchanges of products and/or information.
In the case of PDG, it seems, its very existence is the deliverable. PDG now has a board of directors, chaired by an independent-pharmacy executive, Max Peoples. According to statements to Pharmaceutical Commerce, the PDG board is filled out with representatives from manufacturers, wholesaler-distributors, hospital systems and chain and independent pharmacies—a cross-section of the entire US pharma supply chain. (As of early May, there was still one pharmacy seat to be filled.) “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 Peoples, in a statement.
PDG currently has 45 members, ranging across the supply chain, and a good number of the IT and systems-integration firms working on DSCSA implementations. However, while PhRMA, the Assn. for Accessible Medicines and the Healthcare Distribution Alliance are members, none of the pharmacy (chain, independent or hospital-based) associations have joined in.
PDG’s plan is to set up a variety of workgroups to address DSCSA issues. Already, an Interoperability Committee, chaired by Brian Lee, an executive at Bristol Myers Squibb, is holding regular meetings. Its goal is to have an “Interoperability Blueprint” by the end of this year.