December 20, 2024

Warren, Smith Renew Fight to Strengthen U.S. Pharmaceutical Manufacturing Capacity and End Over-Reliance on Foreign Countries for Life-Saving Drugs

Bill Text (PDF) | Bill One-Pager (PDF) 

Washington, D.C. – U.S. Senators Elizabeth Warren (D-Mass.) and Tina Smith (D-Minn.) reintroduced the Pharmaceutical Supply Chain Defense and Enhancement Act, a bill to reinvigorate the United States' manufacturing capacity and end the nation's reliance on foreign countries for critical drugs used by millions of Americans.

77% of the facilities that manufacture active pharmaceutical ingredients (APIs) used in drugs consumed by Americans are located overseas. As demonstrated by the COVID-19 pandemic, this overreliance leaves Americans vulnerable to supply chain shocks that result in extreme shortages of critical medicines, harming patients and health care professionals across the nation. The United States must take steps to counter this overreliance and ensure that reliable and high-quality drugs can be produced at home.

The Pharmaceutical Supply Chain Defense and Enhancement Act would:

  • Require the Food and Drug Administration (FDA) and Defense Department to develop a confidential list of "critical drugs" essential for public health and national security.
  • Lower the cost of domestic production by providing $1 billion a year for 5 years to the Biomedical Advanced Research and Development Authority, to dramatically upgrade domestic manufacturing capacity of “critical drugs.” 
  • Require the Defense Department, Department of Veterans Affairs, Department of Health and Human Services, and Federal Bureau of Prisons to purchase American-made drugs and provide funding to subsidize the purchase of these drugs, creating a market for domestically-produced pharmaceuticals.
  • Boosts supply chain transparency by requiring drugmakers to annually report to the FDA information about the source of APIs and starting materials used to make drugs consumed in the United States; requiring drugmakers to report information on foreign manufacturers in their supply chain to any federal agency to which they supply drugs; and requiring the FDA to issue both public and classified reports to Congress on the strength of the U.S. supply chain. 
  • Requires the Federal Trade Commission and the Treasury Department to study the role of foreign investment in the U.S. pharmaceutical industry within one year of the Act’s passage. 

"A strong, reliable supply chain for life-saving drugs will prevent shortages and protect American families," said Senator Warren. "This bill will end our overreliance on foreign countries and give us the tools we need to produce the critical drugs that millions of Americans depend on here at home."

"Addressing the vulnerabilities in our pharmaceutical supply chain is a matter of public health and national security," said Senator Smith. "I'm glad to work with Senator Warren on this bill that strengthens our country's capacity to manufacture critical drugs on U.S. soil and closes gaps in our supply chain. This will help lessen our over-reliance on other countries and make sure Americans can get the drugs they need."

Senator Warren also secured a provision in the Fiscal Year 2025 (FY25) National Defense Authorization Act (NDAA) to address DoD’s overreliance on foreign drug manufacturers. The provision requires the Department of Defense to establish a plan to ensure access to safe, high-quality pharmaceutical products and eliminate or mitigate risks in the pharmacy supply chain, including the feasibility of establishing a pharmaceutical manufacturing facility owned and operated by the Department of Defense (DoD). 

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 October 2024, Senators Elizabeth Warren and Marco Rubio (R-Fla.) reintroduced the United States Pharmaceutical Supply Chain Review Act, legislation to require the Federal Trade Commission, in consultation with the Department of Commerce, to produce a report on the impacts of foreign investment in the United States’ pharmaceutical industry. 
  • In March 2024, Senators Elizabeth Warren, 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.) wrote to the Department of Defense requesting an update on the Department’s efforts to address risks to the military pharmaceutical supply chain.  
  • 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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