March 19, 2024

Warren, Rubio, Lawmakers Request Updates from DoD About Implementation of Measures to Address Risks to the Military Pharmaceutical Supply Chain; Release DoD Report

“27 percent of the drugs on the Food and Drug Administration’s Essential Medicines List were categorized by the Defense Logistics Agency as “Very High Risk”.” 

Text of Letter (PDF) | DoD Report (PDF)

Washington, D.C. – Senators Elizabeth Warren (D-Mass.), Marco Rubio (R-Fla.), Richard Blumenthal (D-Conn.), Kevin Cramer (R-N.D.), Joni Ernst (R-Iowa), Mazie Hirono (D-Hawaii), Angus King (I-Maine), Mike Rounds (R-S.D.), and Eric Schmitt (R-Mo.) sent a letter to the Department of Defense (DoD) Secretary Lloyd Austin requesting an update on the Department’s efforts to address risks to the military pharmaceutical supply chain.  

Section 860 of the Fiscal Year 2023 (FY23) National Defense Authorization Act (NDAA) – a provision that stemmed from Senators Warren and Rubio’s Strengthening Supply Chains for Servicemembers and Security Act – directed DoD to develop guidance for risk management of the Department’s pharmaceutical supply chain, report on supply chain vulnerabilities, and establish a working group to develop policies for allocating scarce pharmaceutical resources. 

Last year, drug shortages reached their highest levels since 2014, and over half of drug manufacturers supplying the U.S. market were based overseas in 2022. This poses serious safety and security concerns, as federal regulators generally have reduced ability to conduct oversight in India, China, and other foreign countries to ensure quality products and inputs throughout the entire supply chain. Because only a handful of pharmaceutical companies manufacture any given drug, quality concerns or manufacturing challenges experienced by a single manufacturer can place enormous strain on the entire supply chain, leading to widespread disruptions. 

Last August, DoD announced its intention to enter into a cooperative agreement with Valisure, an independent laboratory, to conduct a pilot study to “generate objective drug quality data” for twelve common drugs, from blood pressure medicine to antidepressants. According to Valisure, the goal of this agreement is to help DoD and other federal agencies diversify their manufacturers, reward good manufacturers, and remove substandard medicine from the supply chain. 

Alongside the letter, the lawmakers are also releasing the Department’s Report on the Department of Defense Pharmaceutical Supply Chain Risks, which DoD prepared in accordance with Section 860 of the FY23 NDAA. The report reveals that 27 percent of the drugs on the FDA’s Essential Medicines List were categorized by the Defense Logistics Agency (DLA) as “Very High Risk” because they are either dependent on Chinese manufacturers using Chinese ingredients or are drugs with unknown sources. The report further found that, out of the 211 drugs DLA examined, 46 were sourced from China and 126 had API sourced from India in 2022.

The lawmakers are requesting more information aboutDoD’s steps to implement Section 860 of the FY23 NDAA and recommendations from the Department’s Office of the Inspector General on pharmaceutical supply chain resilience, as well as an accounting of the Department’s pharmaceutical supply chain disruptions to date. 

For years, Senator Warren has worked to end the United States’ overreliance on foreign countries for critical drugs and to boost the nation's domestic manufacturing capacity:  

  • In December 2023, at a hearing of the Senate Finance Committee, Senator Elizabeth Warren highlighted the need for the public manufacturing of generic drugs to address critical drug shortages and ensure access and affordability of prescription drugs for consumers. 

  • In December 2023, Senator Elizabeth Warren and Representative Jan Schakowsky reintroduced the Affordable Drug Manufacturing Act, to address the skyrocketing price of prescription drugs and increase competition in the generic pharmaceutical market. 

  • In June 2022, during the NDAA negotiations, Senator Warren prioritized her bills to help prevent civilian harm, electrify the military's vehicle fleet, prevent conflicts of interests and corruption at the Department of Defense, prohibit price gouging by defense contractors, expand medical care for military families, lower the costs of prescription drugs, and reduce America's reliance on foreign countries for critical drugs.

  • In December 2021, Senators Elizabeth Warren and Marco Rubio (R-Fla.) sent a letter to Gregory Kausner, who was performing the duties of Under Secretary of Defense for Acquisition and Sustainment at the Department of Defense (DoD), urging him to address DoD’s overreliance on pharmaceuticals produced abroad.

  • In November 2021, Senators Elizabeth Warren and Marco Rubio introduced the Strengthening Supply Chains for Servicemembers and Security Act to address the national security risk posed by the United States’ reliance on foreign entities for pharmaceuticals.

  • In April 2021, Senators Elizabeth Warren and Tina Smith reintroduced the Pharmaceutical Supply Chain Defense and Enhancement Act -- comprehensive legislation that takes bold steps to reinvigorate the United States' manufacturing capacity and end the nation's reliance on foreign countries for critical drugs used by millions of Americans. 

  • In September 2020, Senators Elizabeth Warren and Tina Smith (D-Minn.) wrote to President Donald Trump raising questions about the failure of his recent Executive Order to address the nation's overreliance on foreign nations for key drug products, and asking that he support their legislation, which would address this serious problem.

  • In March 2020, Senators Warren and Rubio introduced bipartisan legislation to combat America's supply chain risk and dependence on China for pharmaceuticals. 

  • In December 2019, Senator Elizabeth Warren, along with Senators Tom Cotton, Mitt Romney, and Tim Kaine, sent a letter to Secretary of Defense Mark Esper raising concerns about the national security risks posed by U.S. reliance on foreign-manufactured pharmaceutical products.

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