In February, the U.S. Food & Drug Administration (FDA) announced plans to pilot new technologies including blockchain, to help in the track and trace of pharmaceuticals. Today IBM, Walmart, Merck and KPMG announced that they’re working together on an FDA blockchain interoperability pilot. There are a total of 20 FDA pilot projects.
The FDA started the program to help companies to comply with DSCSA legislation, which is coming into force in phases. This year there’s a deadline to enable the tracing of returned pharmaceuticals to ensure they’re not counterfeits. The FDA pilots are targeted at more distant deadlines.
There are concerns that some solutions designed to meet the 2019 deadline may not be adaptable for the 2023 targets. And before the FDA set up the pilot program, some had questioned whether the 2023 DSCSA deadline for interoperability is achievable at all.
The IBM pharma network aims to cut down the time to track inventory and improve data sharing amongst network members, as drugs go from the manufacturer to the wholesaler and onwards to the pharmacies. Additionally, the intention is to ensure that medications are kept in proper conditions including temperature. The ultimate goal is compliance with the 2023 interoperability deadline.
IBM is comparatively late to the party as we don’t believe they offer a blockchain solution for the 2019 DSCSA deadline. So instead it’s targeting 2023 requirements. The tech giant is hoping its expertise from the IBM Food Trust is transferable into pharmaceuticals.
IBM’s client Walmart, is also part of Food Trust. “With successful Blockchain pilots in pork, mangoes and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain,” said Karim Bennis, Walmart’s Vice President of Strategic Planning and Implementation, Health and Wellness.
Late last year the FDA hired Frank Yiannas away from Walmart where he headed food safety for a decade. Yiannas was responsible for Walmart’s first Food Trust pilots. He’s now the FDA Deputy Commissioner, Food Policy & Response.