Law aims to mitigate ongoing global drug shortages.
US President Joe Biden has announced approximately 30 new actions aimed at strengthening supply chains critical to national interests. According to the White House, these actions aim to help Americans get necessary products when they need them. Furthermore, the president has invoked the Defense Production Act, enabling investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed as essential to the national defense.1
“And today, we’re coming together to ask a simple question: What’s next?What can we do? What must we do to keep making progress to keep our supply chain stable and secure in the long term, to keep preserving that breathing room—that little bit of breathing room for American families for the season to come, no matter what challenges we face,” Biden said during a speech delivered yesterday.2
Earlier this month, Congress launched an investigation focused on determining what the FDA has been doing in response to current drug shortage issues. The House Committee on Oversight and Accountability sent a formal letter to the agency requesting documents and insights on how the agency is navigating complex supply chains and reductions in domestic manufacturing as a result of drug price controls included in the Inflation Reduction Act (IRA). Previously, FDA commissioner Robert Califf, MD labeled the issue as a threat to national security.3
The FDA also attempted to ease shortages by temporarily authorizing the imports of non-FDA approved cancer drugs manufactured in China, which the US government argues could be dangerous for American citizens.3
To address the ongoing shortages, the Biden administration developed several cross-government supply chain data-sharing partnerships focused on improving supply chain monitoring and strategy, including:
- The Department of Commerce will focus on integrating industry expertise and data analytics to develop innovative supply chain risk assessment tools through its new supply chain center.
- The Department of Transportation will use its Freight Logistics Optimization Works (FLOW) to bring together supply chain stakeholders to create a shared, common picture of supply chain networks and facilitate a more reliable flow of goods. A new FLOW ability will reportedly enable participants to inform their logistics decision-making, helping to avoid bottlenecks, shortening lead times for customers, and enabling a more resilient and globally competitive freight network through earlier warnings of supply chain disruption.1
In a speech at the White House briefing room, President Biden also announced the formation of the Council on Supply Chain Resilience, aiming to ensure stability across US supply chains and to ramp up domestic production of various medicines.2
“I’m charging this group to ensure that our supply chains remain secure, diversified, resilient, and do all—and into the future,” he explained. “I’ve also directed my Cabinet to create an early warning system that uses data to spot subside—supply chains risks to our economic security, our national security, our energy security, and our climate security. And I’m proud to announce that I’ll be invoking what’s known as the Defense Production Act to boost production of essential medicines in America, by American workers.”2
Globally, the administration also announced plans to strengthen supply chain agreements with the European Union, Japan, South Korea, Mexico, Canada, the UK, Australia, WHO, and other global partners. Additionally, the US intends to focus on deepening international early warning systems to detect and respond to supply chain disruptions in sectors considered critical with the previously mentioned allies.1
Other multilateral partnerships include:
- Indo-Pacific Economic Framework for Prosperity (IPEF) Supply Chain Agreement.
- Americas Partnership for Economic Prosperity (Americas Partnership).
- North American Leaders’ Summit (NALS).
- Partnership for Global Infrastructure and Investment (PGI).1
“Two weeks ago, I signed the first-of-its-kind supply chain agreement with 13 countries in the Indo-Pacific,” Biden continued. “This agreement is going to help us identify supply chain bottlenecks…before they become the kind of full-scale disruptions we saw during the pandemic.”
1. FACT SHEET: President Biden Announces New Actions to Strengthen America’s Supply Chains, Lower Costs for Families, and Secure Key Sectors. The White House. November 27, 2023. Accessed November 28, 2023. https://www.whitehouse.gov/briefing-room/statements-releases/2023/11/27/fact-sheet-president-biden-announces-new-actions-to-strengthen-americas-supply-chains-lower-costs-for-families-and-secure-key-sectors/
2. Remarks by President Biden on New Actions to Strengthen Supply Chains, Lower Costs for Families, and Help Americans Get the Goods They Need. The White House. November 27, 2023. Accessed November 28, 2023. https://www.whitehouse.gov/briefing-room/speeches-remarks/2023/11/27/remarks-by-president-biden-on-new-actions-to-strengthen-supply-chains-lower-costs-for-families-and-help-americans-get-the-goods-they-need/
3. Congress Launches Investigation into FDA Drug Shortage Response. Pharmaceutical Executive. November 7, 2023. Accessed November 28, 2023. https://www.pharmexec.com/view/congress-launches-investigation-into-fda-drug-shortage-response
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