USA – Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics

The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.

Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.

The law amends Section 319L of the Public Health Service Act by authorizing BARDA to establish activities to “support, maintain, and improve domestic manufacturing surge capacity and capabilities” through the utilization of advanced manufacturing and platform technologies to increase the availability of medical countermeasures in responding to a public health emergency.

It also calls for BARDA and FDA to communicate on how to award such funding to companies that use advanced manufacturing and platform technologies and to consult on the availability of these countermeasures, and to identify challenges relating to maintaining these capacities…