Regulatory Focus™ > News Articles > 2019 > 6 > Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

Posted 13 June 2019 | By Michael Mezher 

Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

The US Food and Drug Administration (FDA) has selected Merck, IBM, KPMG and Walmart to participate in a pilot evaluating blockchain technology to enhance supply chain security, according to a joint press release from the companies.
The pilot is being conducted as part of the FDA’s effort to develop the interoperable track-and-trace system required under the Drug Supply Chain Security Act (DCSCA) by November 2023.
FDA first announced the pilot in February, and while the agency didn’t specify blockchain technology as a component of the pilot in the Federal Register notice for the pilot, then-FDA Commissioner Scott Gottlieb noted the agency’s interest in blockchain in a corresponding statement.
“We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain,” Gottlieb said, noting that the agency had recently hired blockchain expert and former Walmart Vice President of Food Safety Frank Yiannas.
According to the press release, the four companies will create a shared permissioned blockchain network that will allow drugs and vaccines to be monitored by the participants in real time.
While the interoperable system described in the DCSCA is intended to increase supply chain security and reduce diversion, the companies argue that blockchain technology can go beyond the requirements laid out in the act.
“The proposed network is intended to help reduce the time needed to track and trace inventory; allow timely retrieval of reliable distribution information; increase accuracy of data shared among network members; and help determine the integrity of products in the distribution chain, including whether products are kept at the correct temperature,” the companies said.
The pilot is expected to be completed by the end of 2019. The companies are instructed to provide FDA with a report on the pilot within 30 to 45 business days of its completion, with the agency set to publish information on the pilot in a DSCSA program report.
Press Release

Regulatory Focus newsletters

All the biggest regulatory news and happenings.