“COVID-19 exposed new weaknesses within the domestic supply chain and required agencies to quickly secure critical items needed to combat the pandemic, including personal protective equipment and medical devices like respirators, as well as reduce reliance on foreign manufacturers.”
“As part of its fiscal year 2022 budget proposal, the Food and Drug Administration plans to allocate $21.6 million in funds to establish a new Resilient Supply Chain and Shortages Prevention Program, a permanent program for U.S. supply chain resilience and shortages prevention for medical devices.”
“’The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices,’ said the agency’s Acting Commissioner Janet Woodcock in a press announcement. ‘To ensure the U.S. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts and components.'”
“The move follows an earlier supply chain executive order from President Biden issued to advance the manufacturing capacity and availability and integrity of critical goods, products and services in national emergencies…”
“FDA’s new program will be housed within the agency’s Center for Devices and Radiological Health (CDRH) and will focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply short-falls, and continuing surveillance and rapid intervention.”
“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, FDA Office of Drug Security, Integrity and Response Director Leigh Verbois told GovernmentCIO Media & Research last month…” Read the full article here.
Source: FDA Getting Ahead of Supply Chain Threats With New Program – By Sarah Sybert, August 12, 2021. GovernmentCIO.
