What’s Taking the FDA So Long on COVID Drug Molnupiravir?

The FDA headquarters in White Oak, Md., August 29, 2020. (Andrew Kelly/Reuters)
A breakthrough pill has been approved in the United Kingdom. Americans will have to wait at least a month more.

NRPLUS MEMBER ARTICLE O n October 1, pharmaceutical companies Merck and Ridgeback Biotherapeutics announced that their investigational oral antiviral drug Molnupiravir reduced the risk of hospitalization or death by about 50 percent compared with placebo for patients with mild or moderate COVID-19. Now the breakthrough drug from the two American companies has been approved — in the United Kingdom. Americans will have to wait at least a month more.

The drug is so exciting because it will be the first effective antiviral pill against COVID-19. Remdesivir, the only FDA-approved antiviral for COVID-19, must be administered intravenously in a hospital or in a similar medical setting,

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Joel Zinberg is a senior fellow at the Competitive Enterprise Institute, the director of Paragon Health Institute’s Public Health and American Well-being Initiative, and an associate clinical professor of surgery at the Icahn Mount Sinai School of Medicine. He was general counsel and a senior economist at the White House Council of Economic Advisers from 2017 to 2019.

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