On the 18th June MediLedger announced its blockchain project for the US Food and Drug Administration (FDA) Pilot Program. The project has more than 20 members including leading pharmaceutical companies Pfizer, Genentech (part of Roche), Amgen, Eli Lilly and Gilead. Additionally, it has three of the largest wholesalers McKesson, AmerisourceBergen, and Cardinal Health on board. The big news is the addition of two major retailers in Walgreens and Walmart.
The program aims to produce an interoperable system for traceability in the US pharmaceutical supply chain. The goal is to comply with the Drug Supply Chain Security Act (DSCSA) regulations coming into force in 2023. Before the FDA set up the pilot program in February, some had concerns that the DSCSA deadlines would not be met.
MediLedger has several projects on the go. This announcement relates to the pilot for the 2023 interoperability deadline for the DSCSA legislation. Additionally, this year it’s launching a pharma returns traceability solution to comply with the DSCSA 2019 deadline. MediLedger is also exploring a contracting solution unrelated to DSCSA with several leading pharma companies.
For the FDA pilot, one of MediLedger’s advantages is the breadth of members including pharmaceutical manufacturers, virtual manufacturers, contract manufacturers, repackagers, wholesale distributors, third-party logistics companies, and large retail pharmacy chains.
“The MediLedger pilot’s strength is that it’s a cross-industry effort to explore the use of a blockchain network to enable the interoperability required by the Drug Supply Chain Security Act (DSCSA) requirements in 2023,” stated Matt Sample, the VP of Manufacturing Operations at AmerisourceBergen.
“As founding members of the MediLedger Project, we believe that blockchain technology truly holds promise to further secure the distribution of pharmaceutical products and it is only through a common vision that we will be able to achieve it,” said Genentech’s Pablo Medina.
Scott Mooney, VP of Distribution Operations at McKesson, added: “This is just the beginning of the type of industry-altering impact new technologies like blockchain will have .”
Since the FDA launched its pilot program, 20 projects have joined, including last week’s announcement of an IBM initiative in which Walmart is also participating.