FDA Gives Emergency Authorization of Hydroxychloroquine Use

The Food And Drug Administration (FDA) issued an emergency authorization Sunday for hydroxychloroquine, a drug already used to treat malaria and other ailments, which has shown anecdotal efficacy against coronavirus.

The use of the drug — often paired with azithromycin — has not yet been proven in clinical trials to be effective against the disease. However, given reported success in a growing number of small, non-randomized studies; as well as testimonials from doctors and patients about the use of the “off-label” drug regimen, doctors are said to be prescribing the treatment to patients who are severely ill. Anecdotally, many doctors are taking it prophylactically.

The Department of Health and Human Services (HHS) issued a statement on Sunday:

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) 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.

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HHS also noted that it had “accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials.”

Earlier, the French government had approved similar drugs to treat the virus.

Amid concerns that the sudden interest in hydroxychloroquine could cause shortages, HHS noted: “Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.”