US COVID-19 Relief Law Boosts Pharmaceutical Manufacturing Programs; Is More To Come?
$10bn here and $6bn there on top of what’s left from earlier CARES Act gives government more options on COVID-19 medical countermeasures.
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Nearly four years after introduction and a half-dozen legislative attempts, proposal to establish academic centers of excellence – hoped to help usher in a renaissance in US pharmaceutical manufacturing – secures passage in omnibus spending bill. New law also supports emerging technologies, building on the FDA’s Critical Path Initiative.
Agency seeks bids to train biologics field personnel on relevant aspects of mRNA technology such as corralling stray plasmids or nanoparticles as the possibilities for the technology expand in the wake of the Pfizer/BioNTech and Moderna COVID-19 vaccine successes. Review documents suggest the first mRNA vaccine inspections focused on more traditional issues.
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.