IBM, Merck Assert FDA-Backed Drug Tracing Blockchain A Success!
In their final report to the FDA, the project’s sponsor, the associates called distributed ledger technology (DLT), a safety-enhancing response to the U.S. Drug Supply Chain Security Act (DSCSA), which provides the pharmaceutical industry until 2024 to achieve rigorous new electronic tracing demands on drug packaging.
“With the use of a blockchain-enabled solution, this technology might be able to address the foundational requirement of track and trace for DSCSA in addition to establishing trust between trading partners,” the report stated.
The trial started in June 2019, and the project was created on Hyperledger Fabric. At the time, a Walmart spokesperson stated the company was expecting to create a more transparent supply chain for its consumers.
The companies completed the trial last December. “The pharma supply chain is incredibly complex, given the number of entities and logistics providers and distributors,” stated Tegan Keele, KPMG’s blockchain lead, in a statement. All these players utilize various systems – often, these systems fail to meet DSCSA’s interoperability requirements. The consortium hypothesized that blockchain could be their data bridge, she stated.
Approximately a year after testing began, the consortium discovered its hypothesis correct. The associates said a permissioned blockchain network could bring that extremely fragmented supply chain into DSCSA compliance. The system could trace drug movements while also defining the flow of individual information and, most critically, work across associates that don’t otherwise interact.
Blockchain could also promote product safety by expediting the performance of crucial supply chain safeguards like recalls, the group stated. They evaluated their blockchain could inform downstream partners of recalls in 10 seconds, an “exponentially expedited” improvement over the current pace of up to three days.
“To foster industry adoption, an egalitarian, inclusive, open-sourced commercial solution should be considered to help launch a blockchain network intended for information exchange of the pharmaceutical product transactions in the United States,” the group recorded in its report.
Twenty pilots in total are partaking in the FDA’s DSCSA program, and many feature blockchain and DLT. The FDA is supposed to issue a full final report after all the trials.
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