FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.
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Bowing to President Trump’s latest push to authorize the anti-malarial drug for COVID-19 could damage the reputation of the agency for the duration of the pandemic and beyond, experts say, arguing it may be the best example yet of why the FDA’s decision making needs to be more clearly delineated from the country’s political leadership.
After slow start early in SARS-CoV-2 pandemic, CURE ID now has more than 150 case reports of drugs to treat the coronavirus.
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.