President Biden announces new focus on supply chain security with creation of new cabinet council

US President Joe Biden has announced the creation of a new cabinet-level council to oversee efforts to improve the resiliency of the US supply chain, and the granting of new authorities to the Department of Health and Human Service’ (HHS) to invest in domestic manufacturing of essential medicines under the Defense Production Act (DPA).

These initiatives are part of 30 new actions Biden announced on 27 November to bolster US supply chains.

The US Food and Drug Administration (FDA) reports that in 2022, its drug and biologic centers reported 49 new drug shortages tied to the COVID-19 pandemic (RELATED: FDA saw uptick in drug shortages in 2022, Regulatory Focus 8 June 2023).

Mounting concerns over drug shortages prompted Congress to announce plans to investigate FDA’s response to the crisis. These plans were detailed in a 3 November letter sent by the House Committee on Oversight and Accountability to FDA Commissioner Robert Califf.

The new cabinet-level Council on Supply Chain Resilience will be co-chaired by the National Security Advisor and National Economic Advisor, and include several members, including the Secretaries of Agriculture, Commerce, Defense, Energy, Health and Human Services, Homeland Security, and Housing and Urban Development.

“I’m charging this group to ensure that our supply chain remain secure, diversified, resilient, and do all and into the future,” Biden said.

The new council is charged with reviewing the state of the supply chain every four years; the first review is set to be completed by 31 December 2024. As part of the review, the council will update criteria on industry sector and products defined as critical to national and economic security. The council will implement the criteria 12 months after they are published.

The administration will also be deploying the Defense Production Act (DPA) to speed the manufacture of more essential medicines in the US. The White House said HHS earmarked $35 million for investing in domestic production of key starting materials for sterile injectable medicines. As part of these efforts, HHS will designate a new supply chain resilience coordinator to boost the security of the medical product and food supply chains. In addition, the Department of Defense (DOD) plans to soon release a report on the resiliency of the pharmaceutical supply chain and to ways to reduce reliance on “high-risk” foreign supplies.

Biden also announced a several new cross-government partnerships to improve monitoring of the US supply chains. This includes the Department of Commerce’s Supply Chain Center which will integrate industry experience and data analysis to develop plans to mitigate threats to the supply chain. The center will coordinate an analysis on critical supply chains and will partner with HHS to evaluate import data to address “foreign dependence vulnerabilities and points of failure for critical drugs.”

The administration also announced plans to deepen its collaborations with Australia, Canada, the EU, Japan, the United Kingdom and the World Health Organization (WHO) on strategies to reduce drug shortages. This work is led and coordinated by FDA’s s Global Regulatory Working Group on Drugs Shortages, and will be meeting quarterly.

Announcement, Biden’s remarks