Big Pharma Urges FDA to Use Blockchain for Drug Tracking

MediLedger, a working group comprising 25 major companies operating in the pharmaceutical supply chain has completed a pilot program with the US FDA.

25 leading pharmaceutical manufacturers, distributors, logistic partners, and other representatives of the pharma supply chain have published a report arguing in favor of adopting blockchain technology to track and trace prescription drugs after completing a pilot program with the US Food and Drug Administration.

During early 2019, the FDA began accepting proposals for projects seeking to assist the office 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, the MediLedger Project was approved by the FDA, comprising a working group of 25 major companies operating within the pharmaceutical supply chain seeking to evaluate the blockchain-based MediLedger Network as a vehicle for tracking and tracing prescription medicines in the US.

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.

US pharmaceutical supply chain could suffer without blockchain

The report states the working group believes that the absence of “a central point of data sharing” will result in the US pharmaceutical supply falling behind international competitors as companies “struggle with keeping data accurately and completely shared across a wide variety of partners, systems and technical formats.

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

Zero-knowledge-proofs used to protect confidential information

The MediLedger report notes that data privacy requirements of the pharmaceutical industry can be upheld by maintaining zero knowledge proof technology, ensuring that no business intelligence of confidential information is shared while maintaining the immutability of the blockchain.

Despite asserting that the pilot evidenced that “blockchain has the capability to be the technology underlying an interoperable system for the pharmaceutical supply chain,” the report notes that it is “a complex solution” that would require a stabilization period.

The report also advances that the long-term success of an interoperable blockchain solution will be contingent on “strong participation and adoption from all industry stakeholders.”

Participating companies evaluate MediLedger

The MediLedger project comprised three core technologies: a private messaging system between clients by and trading partners, blockchain as an immutable, shared ledger for transaction validification and smart contract execution, and zero-knowledge to ensure robust privacy for messaging and transfers.

David Vershure, the vice president of channel and contract management at Genentech, asserts that the US pharmaceutical sector’s current point-to-point systems infrastructure 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 stated 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, expressed his satisfaction with the pilot’s execution, stating: "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."