Bill would study and develop action plan to address shortages of important products manufactured abroad and boost production and supply
WASHINGTON – Amid the coronavirus outbreak, U.S. Senators Amy Klobuchar (D-MN) and Tina Smith (D-MN) joined Senators Dick Durbin (D-IL) and Lamar Alexander (R-TN), along with a group of their colleagues to introduce the Commission on America’s Medical Security, bipartisan legislation to safeguard America’s medical supply chain and address shortages of important products manufactured abroad. 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.
“As we continue our work to prevent the spread of coronavirus, it is imperative that America maintains access to safe and secure medical supplies,” Klobuchar said. “This legislation encourages a strong domestic medical product supply chain and helps to identify the critical drugs and devices manufactured abroad that Americans rely on for their health and well-being.”
“As senator, my top priority is to keep Minnesotans healthy and safe,” said Smith. “Our dependence on foreign-made pharmaceutical ingredients and medical supplies is a serious public health risk for our state and the country. I’m glad to help lead this bipartisan effort to mitigate the risk of future drug and medical supplies shortages. Now, Congress needs to act.”
“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 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 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.
In addition to Klobuchar, Smith, Durbin, and Alexander, the legislation was also introduced by U.S. Senators Patty Murray (D-WA), Mitt Romney (R-UT), Doug Jones (D-AL), Roy Blunt (R-MO), Tammy Baldwin (D-WI), Jack Reed (D-RI), 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).
The bipartisan 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.