FDA kicks off pilot program to strengthen drug supply chain
The Food and Drug Administration (FDA) launched a pilot project to encourage the use of innovative and emerging technologies for tracing and verifying prescription drugs in the United States.
WHY IT MATTERS
Under the voluntary program — open to pharmaceutical distribution supply chain members — the pilots will explore and evaluate methods to enhance the safety and security of the supply chain.
"We're giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain," FDA Commissioner Scott Gottlieb said in a statement.
The DSCSA law requires drug manufacturers of pharmaceutical products sold in the United States to serialize, or otherwise uniquely identify, pharmaceutical products.
Importantly, DSCSA also requires that all supply chain participants share certain information for interoperable, electronic tracing of prescription drugs over a 10-year period.
THE BIGGER TREND
The FDA hopes technological innovations will improve the overall security of its system and improve its ability to prevent the introduction of illegitimate products, better detect the introduction of said products, and enable the organization to respond more rapidly when they are found.
Blockchain, for example, offers a promising solution to enable pharmaceutical traceability, real-time access to data and supply chain validation by creating a log to track each step of the supply chain.
One of the key areas of focus for the pilot program is interoperability — the FDA expects technical challenges due to a variety of potential solutions, such as the type of database used and system architecture for exchanging information among trading partners.
The FDA also hopes the pilot program will test the ability of systems to record product status at all packaging levels, as well as data governance, including control and access to data by trading partners, the FDA, and other federal or state officials.
"For the drug track-and-trace system, our goals are to fully secure electronic product tracing,” Gotlieb noted. "We're 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."
PREVIOUS SUPPLY CHAIN WORK
The FDA has previously taken steps to advance the adoption of technologies to identify and trace prescription drugs through the supply chain, including guidance on the use of product identifiers with a unique serial number and verification systems to quarantine and investigate suspect and illegitimate drugs.
Applications for participation in the program start today and run through March 11, 2019.
Nathan Eddy is a healthcare and technology freelancer based in Berlin.
Email the writer: firstname.lastname@example.org