September 02, 2020

Warren, Smith to President Trump: Your Executive Order Won't End U.S. Overreliance on Foreign Nations for Critical Pharmaceutical Products

Senators call on the president to support their legislation to eliminate the public health and national security risks exacerbated by COVID-19 Senators' U.S. Pharmaceutical Supply Chain Defense and Enhancement Act contains the tools needed to solve the problem

Text of letter (PDF)

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) 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.

The Executive Order directs several federal agencies to prioritize the procurement of essential medicines and critical inputs from domestic manufacturers and to promote the manufacturing of these products in the United States. But, it falls well short of its goal. It fails to establish or even recommend guidelines for the list of essential medicines and key inputs the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have been tasked with creating. It does not address the existing loopholes in reporting requirements for drug manufacturers that prevent the federal government from understanding the weaknesses in our supply chain. And the further deregulation and streamlining of FDA and Environmental Protection Agency (EPA) regulations raise concerns, as both agencies are responsible for ensuring manufacturers are producing safe and effective materials. 

"Absent these meaningful actions, your Executive Order will not help address this legitimate national security and public health problem. We ask that you work with us and with other members of Congress on a bipartisan basis to pass legislation to help rectify the failures of your Executive Order and address the public health and national security risks posed by our overreliance on foreign drug producers," wrote the senators

The senators' U.S. Pharmaceutical Supply Chain Defense and Enhancement Act would take a series of comprehensive steps that the Executive Order fails to put in place, like requiring the Biomedical Advanced Research and Development Authority to issue contracts to U.S.-based companies to promote the development of pharmaceutical products domestically, authorizing additional funds for agencies to procure domestically produced drugs and key starting materials, leveraging the federal government's buying power to create a robust and sustainable market, and increasing transparency in the pharmaceutical supply chain by closing reporting requirement loopholes and providing additional resources to federal agencies. 

Last year, a bipartisan congressional commission released a report highlighting the United States' heavy reliance on imports of the essential medicines (and their ingredients) and detailing the potential national security and public health concerns it poses. The commission estimated that the United States imports 80 percent of the active pharmaceutical ingredients (APIs), the raw chemical components of drugs that are required to manufacture pharmaceutical products, used in domestic production of generic drugs and warned of the dangers of this overreliance. 

Overreliance on imports of pharmaceutical products and a lack of domestic manufacturing capacity pose several public health and national security risks to the nation: 1) Without sufficient domestic capacity, the U.S. is vulnerable to supply chain interruptions, and experts have warned that if importation of medicines or key materials were to be disrupted, "military and civilian hospitals and clinics would cease to function within months if not days." 2) Lax regulatory requirements abroad have allowed some low-quality and unsafe products to enter circulation in the United States, leading to the deaths of many Americans. 3) Medication "can be weaponized," withheld, or "sold without any real medicine" if developed by an adversary.  This is particularly true of the Department of Defense (DoD) and the Department of Veterans Affairs (VA), which purchase drugs in bulk for military and veteran hospitals. Today, nearly roughly 25% of DoD pharmaceutical ingredients used in military hospitals originate from China. 

The senators asked President Trump to provide specific steps his Administration will take to end the country's overreliance on foreign pharmaceutical products and urged him to work with them and other members of Congress on a bipartisan basis to pass legislation to help rectify the failures of his Executive Order and address the public health and national security risks posed by our overreliance on foreign drug producers.