Consortium Costs Debated As BARDA, Industry Discuss Plans For Next Pandemic Response
BARDA’s consortium approach scrutinized as industry recovers from US Defense Production Act rated orders. Questions of sustainment fees, interruptible commercial activities explored during BioMaC Industry Day call as agency emphasizes need for proven capacity.
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Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements – provides the framework to mitigate against and respond to drug shortages.
COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
Committee's bipartisan discussion draft for legislation outlines lessons learned from COVID-19 pandemic response, including need for greater manufacturing facility readiness. Meanwhile, congressional oversight agency calls for “transformation” of response efforts.