FDA Blockchain Pilot

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

In February 2019, the US Food and Drug Administration (FDA) announced in the Federal Register the implementation of pilot projects related to the Drug Supply Chain Security Act (DSCSA). The intention was to "assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States". Blockchain technology wasn't mentioned directly in this document. However FDA has now selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security: Merck, IBM, KPMG and Walmart. This pilot is part of FDA's effort to develop the interoperable track-and-trace system which is required under the DCSCA by November 2023.

In a press release, Craig Kennedy, Senior Vice President, Supply Chain, at Merck, (MSD outside the U.S. and Canada) points out that Merck's "supply chain strategy, planning and logistics are built around the customers and patients" and that "reliable and verifiable supply helps improve confidence among all the stakeholders-especially patients-while also strengthening the foundation of our business."

What about Europe?

A consortium of various universities (Frankfurt University of Applied Sciences, RheinMain University of Applied Sciences, Fulda University of Applied Sciences) and operational partners (e.g. Bayer AG, Boehringer Ingelheim Pharma GmbH & Co. KG, GEFCO Forwarding Germany GmbH) has developed a validated web-based platform called MYTIGATE. It is intended to support companies within the pharma supply chain and help them to "identify, analyze, evaluate and mitigate their Supply Chain Risk Management".