FDA issues emergency authorization of anti-malaria drug for coronavirus care

Source: Politico | March 29, 2020 | Dan Diamond

The drugs have been championed by President Donald Trump for treatment despite scant evidence.

The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.

The agency allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.

The move was supported by the White House, part of a larger Trump-backed effort to speed the use of anti-malaria drugs as a potential therapy for a virus that has no proven treatment or cure. FDA already has allowed New York state to test administering the medication to seriously ill patients, and some hospitals have added it to their treatment protocols.

“Let’s see how it works,” Trump said at a press briefing on Sunday, referencing New York state’s efforts. “It may. It may not.”

Career scientists have been skeptical of the effort, noting the lack of data on the drug’s efficacy for coronavirus care and worried that it would siphon medication away from patients who need it for other conditions, calling instead for the agency to pursue its usual clinical trials.

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