The US Food and Drug Administration’s (FDA) project will work with representatives of the drug supply chain and will use new innovations and approaches for securing it. The purpose of the program is to inform the development of electronic track-and-trace system technology and innovations for the industry that are set to go into effect in 2023 as part of the agency’s Drug Supply Chain Security Act (DCSA).
A spokesperson for the FDA told us the program is “a means for the FDA and stakeholders to share learnings and information obtained from the pilots in an open way to further inform the 2023 system. When the program concludes, the FDA intends to issue a final report.”
FDA’s DSCA was enacted by the US Congress in 2013 and states the steps to build an electronic, interoperable system to trace prescription drugs through distribution in the US.
The track-and-trace system will aim to reach the FDA’s goals of fully securing electronic product tracing to provide a step-by-step account of where a drug product has been and who has handled it. According to the FDA, it is open to considering all viable technologies and methods that fit the purpose of the project.
This program is set to begin in the first quarter of 2019 and while the FDA is opening this program up to representatives, participants will be responsible for the funding and resources necessary to work within the program, the spokesperson explained.
FDA Commissioner, Scott Gottlieb, made a statement on the pilot program suggesting that the new innovations can improve the security of its closed system and improve the prevention of illegitimate products entering the supply chain.
“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,” he explained further.
According to the FDA, the ability to establish this type of product verification allows the agency to ensure that a drug product is both legitimate and creates the ability to ensure that any party involved in the supply chain can investigate any suspect drug.
This program is not the first step the FDA has taken to advance track-and-trace and verification technologies. Most recently, it issued draft guidance on the use of product identifiers with serial numbers used in an aim to improve verification at the package level.
The FDA has also provided draft guidance for verification systems to quarantine and investigate suspect and illegitimate drugs.