In introducing the Pharmaceutical Supply Chain Risk Assessment Act last week, U.S. Sens. Gary Peters (D-MI) and Joni Ernst (R-IA) proposed an assessment of pharmaceutical supply chain vulnerabilities and toeing plans to reduce reliance on foreign manufacturing.
The issue is a long-running one, but perhaps best highlighted during the early days of the COVID-19 pandemic, when borders were sealed and nations struggled to keep necessary supplies moving. In two previous reports from Peters, overdependence on foreign sources for critical drug products and a lack of transparency surrounding U.S. pharmaceutical supply chains were cited as major national security concerns.
“Our federal government’s lack of visibility into the entire supply chain for critical medications limits our ability to address drug shortages that pose a serious national security risk and could compromise medical care for people all across the country, including service members,” Peters said. “This bipartisan legislation will provide the federal government with a better understanding of how our overreliance on foreign nations for critical drugs threatens our military readiness and creates health risks for Americans, which will help lawmakers ensure our nation is better able to mitigate these national security threats. This is just the first step, and I am continuing to work on additional legislation that will help strengthen our drug supply chains and prevent drug shortages.”
The bulk of foreign suppliers of raw materials for these drugs are centered in China and India. Between 2010 and 2015, the number of Chinese-based manufacturers of key ingredients needed to make drugs more than doubled, according to Peters, a particularly troubling finding when coupled with a 2021 Department of Defense (DoD) Inspector General report that found the U.S. military is likewise reliant on such sources for drugs – even as tensions between China and the U.S. continue to rise.
Enter the Pharmaceutical Supply Chain Risk Assessment Act, which would require the DoD, Department of Health and Human Services (DHHS) and Department of Homeland Security (DHS) to undertake assessments of pharmaceutical supply chain vulnerabilities and related national security risks, and then to create plans to reduce those vulnerabilities and foreign reliance overall. They would also need to build on existing lists of critical drugs and use those lists to identify which drugs and key ingredients have vulnerable supply chains.
“The United States cannot continue to rely on our foreign adversaries, like China, for critically important materials to meet the medical needs of Americans,” Ernst said. “I’m sounding the alarm on our compromised medical supply chain. It’s past time to reduce our reliance on bad actors and protect the health of our citizens now and in the future.”
The bill received the backing of the Association for Clinical Oncology and the American Society of Health-System Pharmacists.