What Do You Think of the FDA's COVID-19 Decisions?

September 02, 2020

In an open letter to Stephen Hahn, MD, the commissioner of the US Food and Drug Administration (FDA), Medscape Editor-in-Chief Eric Topol, MD, detailed why he thinks recent FDA authorizations of interventions to treat COVID-19 have not been evidence-based. 

Topol cited three emergency use authorizations (EUAs) that he says were not evidence-based: one for hydroxychloroquine on March 30 (revoked in June for lack of evidence), one for convalescent plasma on August 23, and an expanded EUA for remdesivir to treat any hospitalized COVID-19 patient, not just those with severe disease.  

Topol also cited a recent interview in which Hahn said he was prepared to authorize a COVID-19 vaccine before Phase 3 trials were complete.

"These repeated breaches demonstrate your willingness to ignore the lack of scientific evidence, and to be complicit with the Trump Administration's politicization of America's healthcare institutions," Topol wrote.

Tell us what you think about these decisions.

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