The Food and Drug Administration is advising industry partners on new guidance for identifying and tracing prescription drugs as they move through the distribution supply chain to ensure availability of critical drugs during the pandemic, Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response, told GovernmentCIO Media & Research.
Overall, FDA’s supply chain strategy is aiming to do three things: detect illegitimate products, prevent them from entering the supply chain, and rapidly respond when they are found.
The move comes amid President Biden’s Executive Order on America’s Supply Chains and also ahead of drug-distribution security requirements that are set to go into effect in November 2023 as part of the Drug Supply Chain Security Act signed into law in 2013.
While the law outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed, it also called on FDA to develop processes for waivers and exceptions, such as for emergency medical reasons or space constraints.
“[The new guidance] was triggered because we felt the need to explain emergency medical reasons that were exempted, such as those needed to address the COVID public health emergency,” Verbois said. “This was something that we knew we needed to balance the need to effectively distribute prescription drugs under emergency conditions and help protect consumers from exposure to prescription drugs that could be counterfeit, stolen or otherwise harmful.”
Since the legislation, the agency has helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products, Verbois said. The FDA will build upon its foundation to make continuous improvements to its supply chain and drive a more secure, robust system.
“We’re working to develop an enhanced system along with stakeholders. FDA requires that the development of the enhanced system across the supply chain will be complex, and the elements described in our recent guidances on the system at the package level are important parts of this robust system,” Verbois said.
While each trading partner should have its own individual validated system and processes for managing product data, FDA is recommending that the enhanced system enable the interoperable integration of individual systems to boost access, assist in information sharing and bolster data security.
“In essence, everything needs to work together. The enhanced system should allow FDA and others to communicate with trading partners’ individual systems and receive that information upon request,” Verbois said.
From its successes, FDA is looking into how it can leverage best practices and lessons learned to realize new benefits in areas like documentation of patient records, medication records, health care administration and drug inventory management.
“Leveraging existing data, and even existing systems, when possible will benefit everybody. We’re doing our part to effectively put supply chain security requirements in place while understanding and balancing the needs and capabilities of members throughout the supply chain,” Verbois said. “In the end, we’re working toward protecting the supply chain and ensuring that patients do not receive harmful products.”