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 U.S. 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).
“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.”
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.