The United States must shore up medical product supply chains before the next pandemic or other natural disaster, warns a new National Academies of Sciences, Engineering and Medicine (NASEM) expert panel report.
The "Building Resilience into the Nation's Medical Product Supply Chains," released on Mar 3, was sponsored by the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). Congress mandated its publication as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.
US heavily reliant on foreign manufacturers
Disruptions to the medical supply chain, such as those from infectious disease outbreaks, geopolitical conflicts, and quality issues at drug-production sites, affect health, cost medical facilities millions each year, and they can bring clinical research to a halt—all longstanding issues brought to the fore by the COVID-19 pandemic—the document says.
"Because medical product supply chains are complex, multi-level, globally-distributed systems that involve people, processes, technologies, and policies, they are vulnerable to many types of risk, as well as amenable to many types of remediation," according to the report.
Throughout the pandemic, hospitals and nursing homes were forced to make difficult decisions when confronted with limited supplies of drugs, ventilators, and personal protective equipment such as N95 respirators. At the same time, some manufacturing plants closed, leaving makers of diagnostics, treatments, and vaccines to jockey for raw materials.
The United States depends heavily on foreign sources for medical products and active pharmaceutical ingredients (APIs) for making drugs, the report noted. For instance, only 28% of the manufacturing facilities making APIs for the US market were located in the United States as of August 2019.
Another example cited in the report is the anticoagulant heparin, which is made using pig intestines; China makes 80% of the world's heparin and 60% of the US supply. In 2007, an infectious disease outbreak in Asia decimated pig herds, pushing heparin into short supply and doubling prices. As a result, the report says, the US Food and Drug Administration (FDA) is asking bovine heparin manufacturers to submit applications.
But relocating entire medical supply chains from overseas back to the United States is expensive, leading to higher prices, and the move can lead to vulnerability from regional disasters such as earthquakes.
"Disruptions in the supply chain have greater implications than making people wait for a new television set," Wallace Hopp, PhD, of the University of Michigan, chair of the committee behind the report, said in an American Economic Association news release. "They have the potential to seriously compromise patient care."
Disclosure, failure-to-supply penalties needed
The seven recommendations in the report fall into the categories of awareness, mitigation, preparedness, and response. They are:
- The FDA should work to make public sourcing, drug manufacturing volume and capacity, and quality information for all medical products approved or cleared for sale in the United States, the report says. "The public should have access to information about where and how medical products are made, and where they are in the supply chain."
- The FDA and ASPR should "cultivate capacity-buffering for supply-chain critical medical products where such capacity is a cost-effective complement to stockpiling and as protection against long-lasting supply disruptions or demand surges."
- ASPR should develop strategies to modernize and optimize inventory stockpiling management for the Strategic National Stockpile and beyond.
- Major medical-product exporters such as the United States should create a multinational treaty under the World Trade Organization that prohibits export bans and limitations on key components of global medical product supply chains. "Any country that violates the terms of this agreement should be subject to reputational, economic, or legal sanctions by other signatories," the report states.
- Device manufacturers should disclose the site of manufacture of first and last assembly steps for all products and major components sold in the United States. The reporting requirement of the CARES Act should be extended to medical devices and made public, and capacity should be added to the list of required information.
- Healthcare systems should include "failure-to-supply penalties for contracts requiring a committed purchase or purchase volume" in their agreements with medical product suppliers and prioritize awarding contracts to "suppliers that can demonstrate superior quality and reliability."
- ASPR and the Centers for Disease Control and Prevention should convene a working group of key stakeholders to identify effective last-mile strategies to ensure that end users can respond in the event of medical product shortages.
Victor Dzau, MD, president of the National Academy of Medicine, said in the news release that the more secure the medical supply chain, the more Americans will trust it. "Increasing transparency about the availability and quality of medical products—a major aspect of this report—is a fundamental step in earning the public's trust and confidence," he said.
The report follows a February HHS report on the public health supply chain and industrial base.
