The US Food and Drug Administration (FDA) has launched a new pilot program as part of its implementation of the Drug Supply Chain Security Act (DSCSA), a federal law that outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US.
The DSCSA Pilot Project Program is a voluntary program open to participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders). 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 DSCA. The FDA says the new program will pilot technologies that may become part of the enhanced expectations for reliable track-and-trace systems. The FDA says the new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain.
“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,” said FDA Commissioner Scott Gottlieb in a February 7, 2019 agency statement. “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.”
DSCSA, which was signed into law in November 2013, has staged implementation over a 10-year period and is designed to create a system that will facilitate the exchange of information (i.e., transaction information, transaction history, and transaction statement) at the individual package level about where a drug has been in the supply chain
“This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply,” Gottlieb said in the February 7, 2019 agency statement. “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.”
The DSCSA pilot-project program is intended to help identify and evaluate the most efficient processes to comply with and apply drug supply-chain security requirements. The program will aid in identifying attributes the system will need for enhanced product tracing and verification as well as electronic means to share the information. The FDA said it will share new approaches considered through the pilot program with the broader drug supply-chain community. The pilot program is part of other initiatives by the FDA to advance the development and adoption of technologies that can help identify and properly trace prescription drugs as they move through the supply chain. 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. It also also provided draft guidance for verification systems to quarantine and investigate suspect and illegitimate drugs.
“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,” Gottlieb said in the statement. Gottlieb also noted that the FDA is exploring the use of technology in its regulation of other product supply chains, such as in the food supply chain, which may have potential in the drug 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 said in the statement. To advance these efforts, the FDA recently named Frank Yiannas as Deputy Commissioner for Food Policy and Response, a position he assumed in December of 2018, and who serves the principal advisor to the FDA Commissioner in the development and execution of policies related to food safety, including implementation of the FDA Food Safety Modernization Act. He was formerly Vice President of Food Safety for Walmart. “He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the US food supply,” said Gottlieb in the agency statement.