US FDA's decision to revoke the COVID-19 emergency use authorization for two anti-malarial drugs keeps with commissioner Hahn's stated goal of moving fast to tackle the pandemic, but shifting course as new data comes available. FDA cited new evidence as well as a reanalysis of the data it initially based the EUA on as reasons for pulling the authorization. Meanwhile, HHS Secretary Alex Azar appeared to equate the EUA revocation as opening the doors for broader use of the medicine, potentially undermining FDA's own communication on the drug, in yet another example of political leaders complicating the science and public health response to COVID-19.
The US FDA revoked on 15 June the emergency use authorization for two anti-malarial drugs, hydroxychloroquine and chloroquine less than three months after granting the EUA, concluding that it is no longer reasonable to believe the drugs may be effective in treating hospitalized COVID-19 patients. New safety concerns along with lingering worries of cardiac risks with the drugs also factored into the agency’s latest risk-benefit calculus.
The decision appears to be keeping with Commissioner Stephen Hahn’s stated goal of making fast decisions during the pandemic, using...
