WASHINGTON—U.S. Senator Mitt Romney (R-UT) joined his colleagues, led by Senators Lamar Alexander (R-TN) and Dick Durbin (D-IL), in introducing the Commission on America’s Medical Security Act, bipartisan legislation to safeguard America’s medical supply chain and address shortages due to the United States’ dependence on foreign-made medical equipment. Approximately 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are manufactured overseas—primarily from China and India. The ongoing global coronavirus outbreak has highlighted broader public health and national security vulnerabilities stemming from our nation’s reliance upon foreign manufacturing and the shortcomings in our regulatory oversight of global supply chains. On February 27, the Food and Drug Administration (FDA) announced the first coronavirus-related drug shortage, and on March 10, the FDA halted its routine overseas inspections of drugs and devices.
“With recent reports of drug shortages, the outbreak of the coronavirus highlights the extent of United States’ reliance on foreign-manufactured pharmaceuticals and the risk that poses to our health and safety,” Senator Romney said. “Our legislation will task a special commission to develop a strategy that will safeguard our medical supply chain to prevent sole reliance on China for critical drugs, devices, and equipment.”
“The global coronavirus outbreak has heightened awareness around the vulnerability we have when it comes to American reliance on foreign-made medical supplies. When a public health emergency or national security crisis occurs in China or other countries that disproportionately provide us with medical supplies, the United States is at risk of a shortage of drugs or health care equipment. We have to develop a strategy to strengthen domestic production and supplies, and our bill tasks a commission to achieve those solutions,” said Senator Durbin.
“We are asking the National Academy of Sciences to look into what exactly the impact is on our country of having medicines and medical supplies made overseas. The U.S. Food and Drug Administration estimates that about 13 percent of the facilities that make active ingredients for drugs used by Americans are in China, and the coronavirus outbreak has demonstrated the need to better understand where drugs and devices are made and how they get to consumers,” said Senator Alexander.
In December, the U.S.-China Economic and Security Review Commission sounded the alarm on the “growing reliance” on drugs and precursors produced, in many cases exclusively, in China. This week, state health departments and the Centers for Disease Control and Prevention (CDC) have raised concerns about a looming shortage of coronavirus extraction kit reagents needed to conduct diagnostic testing.
Joining Senators Romney, Alexander, and Durbin in introducing the legislation include Senators Patty Murray (D-WA), Doug Jones (D-AL), Roy Blunt (R-MO), Tina Smith (D-MN), Tammy Baldwin (D-WI), Jack Reed (D-RI), Amy Klobuchar (D-MN), and Richard Blumenthal (D-CT). A House companion bill will be introduced by U.S. Representatives Raul Ruiz (D-CA-36), Lauren Underwood (D-IL-14), and Phil Roe, M.D. (R-TN-01).
Specifically, the Commission on America’s Medical Security Act would direct the National Academies of Sciences, Engineering, and Medicine to:
- Assess the dependence of and vulnerabilities to the United States, including the private commercial sector, states, and Federal agencies, on critical medications, medical devices, and medical equipment that are sourced from or manufactured in foreign countries.
- Provide recommendations and an action plan to improve the resiliency of the supply chain for critical drugs, devices, and equipment, including to increase domestic manufacturing capabilities, supplies and stockpiles, and improve information collection and contingency planning.
- Consult, in the development of its report, with federal agencies—including Departments of Health and Human Services, Homeland Security, Defense, Commerce, State, Justice, and Veterans Affairs—as well as public health, medical, and commercial industry stakeholders.