Thursday, March 12, 2020

U.S. Senator Tammy Baldwin Helps Introduce Bipartisan Bill to Address Medical Supply Vulnerability Due to Coronavirus

baldwin

Senator Tammy Baldwin's office issued the following today:



3.12.20

Bill would study and develop action plan to address U.S. dependence on foreign-made medical equipment and boost domestic production and supply

WASHINGTON, D.C. - Amid the coronavirus outbreak, U.S. Senator Tammy Baldwin, a member of the Senate Committee on Health, Education, Labor and Pensions (HELP), helped introduce the Commission on America’s Medical Security Act, bipartisan legislation led by Senators Dick Durbin (D-IL) and Lamar Alexander (R-TN) 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.

“The coronavirus outbreak makes it clear that our country is over-reliant on medical supplies from other countries and that we need stronger policies in place to ensure we have access to American-made supplies when we need them most,” said Senator Baldwin. “In order to effectively respond to public health emergencies, I believe we need to scale up our Made in America manufacturing capabilities so we have the supplies and resources we need here at home.”

“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 Baldwin, Durbin and Alexander in introducing today’s legislation includes Senators Patty Murray (D-WA), Mitt Romney (R-UT), Doug Jones (D-AL), Roy Blunt (R-MO), Tina Smith (D-MN), 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).

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.