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.

US FDA Commissioner Stephen Hahn is pictured on a billboard asking people who have recovered from COVID to “help us save lives” by donating plasma, although the treatment has not been shown to be safe and effective. • Source: screenshot of tweet

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