FDA Is Urged to Implement Blockchain for Drug Tracking

25 major representatives of the pharma supply chain, including pharmaceutical manufacturers, distributors, logistic partners, and other, have released a report urging to implement blockchain for tracking and tracing prescription drugs after finishing a pilot program with the U.S. Food and Drug Administration (FDA).

During early 2019, the FDA started to accept propositions for projects which could help the organization meet the 2023 requirements of the Drug Supply Chain and Security Act (DSCSA), which requires the pharmaceutical industry to track “legal changes in ownership of pharmaceuticals in the supply chain.”

In June 2019, FDA’s working group, which incorporated 25 major companies operating within the pharmaceutical supply chain, approved the MediLedger Project in order to evaluate its blockchain as a means for tracking and tracing prescription drugs in the U.S.

MediLedger’s members include multinational pharmaceutical giant Pfizer, drug wholesaler AmerisourceBergen, operator of the United States’ second-largest pharmacy chain Walgreens, multinational retail corporation Walmart, and delivery services company FedEx.

U.S. pharmaceutical supply chain could suffer without blockchain

According to the report, the working group is sure that if “a central point of data sharing” is missing, the U.S. pharmaceutical supply will fall behind international competitors as companies “struggle with keeping data accurately and completely shared across a wide variety of partners, systems and technical formats.”

The report also warns that if a major public health crisis occurs, stakeholders and agents will struggle to locate and quarantine suspect product in a timely manner, continuing to put patients’ lives at stake,” noting that “using the advancements of technology like blockchain can avoid these significant risks.”

Zero-knowledge-proofs used to keep sensitive information safe

The MediLedger report states that data privacy requirements of the pharmaceutical industry can be met by implementing zero knowledge proof technology, ensuring that no buisness intelligence of confidential information is shared while keeping the immutability of the blockchain.

Despite stressing that the pilot showed that “blockchain has the capability to be the technology underlying an interoperable system for the pharmaceutical supply chain,” the report states that it is a “a complex solution” which would need time for stabilization.

The report further notes that the long-term success of an interoperable blockchain solution will depend on “strong participation and adoption from all industry stakeholders.”

Members of the working group evaluate MediLedger

The MediLedger project incorporates three primary technologies: a private messaging service between clients by and trading partners, blockchain as an immutable, shared ledger for transaction verification and smart contract execution, and zero-knowledge protocols to provide strong privacy for messaging and transfers.

David Vershure, the vice president of channel and contract management at Genentech, believes that the present-day infrastructure of the U.S. pharmaceutical industry’s point-to-point systems is “lack[ing] the ability to keep data in-sync across the healthcare supply chain, which ultimately increases the risk of counterfeit, diverted or otherwise illegitimate products.”

The Genentech representative noted that the pilot “serves as a key milestone in demonstrating that blockchain technology is a viable option to address the complexity of building an interoperable system needed for DSCSA 2023.”

Mack MacKenzie, Pfizer’s vice president of digital market access and revenue management solutions, was satisfied with the blockchain drug tracking solution pilot with the FDA, saying:

“I am very encouraged by this demonstration of broad industry commitment to an interoperable system that achieves DSCSA compliance. It is exciting to imagine how we can build on this success to jointly deliver transformative digital services that add more value for patients.”