Preapproval Promotion? US FDA Commissioner Touts ‘Lifesaving’ Investigational Plasma For COVID-19
Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.
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US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.
Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.
Medicare’s New Codes For Remdesivir, Convalescent Plasma To Be Test Of Real-World, Though Not Real-Time, Data
CMS’s new procedure reimbursement codes will help generate ‘critical information’ on the effectiveness of the COVID products, but will suffer from a ‘claims lag.’