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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.
The legislation also directs BARDA to consult with FDA to ensure that facilities are awarded funding comply with current good manufacturing practices (GMPs).
Lastly, it calls on GAO to report to Congress on the sustainability of this manufacturing capacity and how BARDA is assessing the ability of its award recipients to manufacture medical countermeasures rapidly.
BARDA funds are used to support US efforts to develop and create manufacturing bases in the US. Past award recipients include a new advanced manufacturing laboratory at Virginia Commonwealth University (VCU) in Richmond (RELATED: USP, Phlow say new labs will bolster continuous manufacturing, Regulatory Focus, 13 December 2022).
BARDA is an agency within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.
The FY 2023 spending bill was signed by President Biden on 27 December (RELATED: This Week at FDA: Congress passes omnibus spending bill, securing budget increase for FDA, Regulatory Focus 23 December 2022).
Omnibus bill
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.
The legislation also directs BARDA to consult with FDA to ensure that facilities are awarded funding comply with current good manufacturing practices (GMPs).
Lastly, it calls on GAO to report to Congress on the sustainability of this manufacturing capacity and how BARDA is assessing the ability of its award recipients to manufacture medical countermeasures rapidly.
BARDA funds are used to support US efforts to develop and create manufacturing bases in the US. Past award recipients include a new advanced manufacturing laboratory at Virginia Commonwealth University (VCU) in Richmond (RELATED: USP, Phlow say new labs will bolster continuous manufacturing, Regulatory Focus, 13 December 2022).
BARDA is an agency within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.
The FY 2023 spending bill was signed by President Biden on 27 December (RELATED: This Week at FDA: Congress passes omnibus spending bill, securing budget increase for FDA, Regulatory Focus 23 December 2022).
Omnibus bill
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