One of the main missions of the U.S. Food and Drug Administration’s mission is to ensure that all products we regulate, including consumer drugs, are safe and of high quality.
This means working to ensure greater accountability in the drug supply chain.
As part of these efforts, the agency is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracking and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain.
The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act. This new program will pilot technologies that may become part of our enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.
“As part of our ongoing efforts to protect our nation’s drug supply, today, 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. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found,” said FDA Commissioner Scott Gottlieb, M.D.
According to Gottlieb, tracking and tracing product is critical to the industry’s ability to detect and remove potentially dangerous drugs from the supply chain.
The FDA is 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.
“For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it; establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to make sure that any party involved in handling drugs in the supply chain must have the ability to spot and quarantine and investigate any suspect drug. We’re committed to staying at the forefront of new and emerging technologies and how they might be used to create safer, smarter and more trusted supply chains to better protect consumer safety and ensure the integrity of the high quality of products they deserve.” said Gottlieb.
This is not the first step that the FDA has taken to identify and properly trace prescription drugs as they move through the supply chain. For example, the FDA recently issued draft guidance on the use of product identifiers with a unique serial number to improve verification down to the package level. Additionally, the FDA has provided draft guidance for verification systems to quarantine and investigate suspect and illegitimate drugs. Enhanced verification and tracing in the supply chain can translate to a more rapid response by industry and the FDA when an illegitimate product is found.