IBM, Merck Declare FDA-Backed Drug Tracing Blockchain a Success

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IBM, Merck, Walmart and KPMG’s drug-tracing blockchain pilot has exceeded the benchmarks outlined by the U.S. Food and Drug Administration, the group announced Monday.

In their final report to the FDA, the project’s sponsor, the partners called distributed ledger technology (DLT) a safety-enhancing answer to the U.S. Drug Supply Chain Security Act (DSCSA), which gives the pharmaceutical industry until 2024 to implement stringent new electronic tracing requirements 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 said.

Related: IBM, Mastercard Join Digital Identity Project Building ‘Ecosystems of Trust’

The trial began in June 2019 and the project was built on Hyperledger Fabric. At the time, a Walmart spokesperson said the company was hoping to build a more transparent supply chain for its customers.

The companies completed the trial last December.

“The pharma supply chain is really incredibly complex, given the number of entities and logistics providers and distributors,” said Tegan Keele, KPMG’s blockchain lead. All these players use different systems – oftentimes, these systems fail to meet DSCSA’s interoperability requirements. The consortium’s hypothesis was that blockchain could be their information bridge, she said.

Nearly a year after testing began, the consortium found its hypothesis correct. The partners said a permissioned blockchain network could bring that highly fragmented supply chain into DSCSA compliance. The system could track drug movements while also limiting the flow of private information and, most critically, work across partners that don’t otherwise interact.

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