U.S. Senators Mitt Romney (R-UT) and Maggie Hassan (D-NH), members of the Health, Education, Labor, and Pensions (HELP) Committee, today introduced the Medical Countermeasures Surge Capacity Act of 2022, legislation to improve our domestic manufacturing surge capacity and capabilities for biodefense and pandemic preparedness and response. Their legislation has been included in the recently released discussion draft of the HELP Committee’s bipartisan pandemic response bill, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
“More than two years into the pandemic, we continue to see a lack of capacity in medical countermeasure manufacturing—most recently experiencing a testing shortage,” Senator Romney said. “One of the ways we can improve is by providing our public health agencies the tools to support critical manufacturing on an ongoing basis, which this legislation will equip us to do.”
“We can’t be caught flatfooted when another public health emergency health like COVID-19 strikes,” said Senator Hassan. “We need to invest in American manufacturing and research so that we don’t have to rely on a country like China during a crisis. New England is home to some of the best medical research companies in the world – this bipartisan bill would make critical investments now and better ensure that we are prepared for the threats of tomorrow.”
The Biomedical Advanced Research and Development Authority (BARDA) is the authority within the Federal Government for advanced research and development of medical countermeasures, including drugs, vaccines, and diagnostic tools, in response to bioterrorism, antimicrobial resistance, pandemic influenza, and emerging infectious diseases. BARDA works strategically with the public and private sectors to accelerate medical countermeasure innovation and development.
However, BARDA’S ability to support manufacturing capacity for medical countermeasures has only been used for pandemic influenza, and further restricted in the type of operationally ready facilities the agency can support. These limitations hamper our nation’s ability to support, maintain, and improve domestic manufacturing surge capacity for any qualified medical countermeasure.
The Medical Countermeasures Surge Capacity Act of 2022 expands BARDA’s authority to ensure a warm base for any qualified medical countermeasure, pandemic, or epidemic product. With this expanded authority, BARDA can support the entire lifecycle of a countermeasure—from initial research and development to surge manufacturing capacity and capabilities in an emergency.
Additionally, the Medical Countermeasures Surge Capacity Act of 2022 builds in important coordination with the Food and Drug Administration (FDA) to ensure manufacturing facilities maintain good manufacturing practices and are in compliance with FDA inspections.