Discussion of the controversial approval of remdesivir as the first FDA-approved drug for COVID-19 treatment in October 2020. Despite mixed results from clinical trials, including the large WHO Solidarity study that showed no significant benefits, the FDA approved remdesivir without consulting the external advisory committee. The European Union also agreed to a billion-dollar deal with the drug's manufacturer just before the disappointing WHO trial results were released, while the results were known to the manufacturer. Authors highlight concerns about the FDA's decision-making process, Gilead's aggressive marketing despite questionable efficacy, and the lack of transparency in both the FDA approval and EU procurement. Critics argue that the available data did not support such a strong endorsement of remdesivir, and that public discussion of the evidence would have been beneficial.
Cohen et al., 28 Oct 2020, preprint, 2 authors.
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