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.

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.”

President Donald Trump has suggested that hydroxychloroquine could be effective, and has encouraged further study. His interest in the drug has prompted pushback from the media.

NBC News’ Peter Alexander accused the president last week of giving Americans “false hope,” and Politico’s Dan Diamond reported Sunday that the FDA decision came despite “scant evidence,” adding that “[c]areer scientists have been skeptical of the effort.”

Joel B. Pollak is Senior Editor-at-Large at Breitbart News and the host of Breitbart News Sunday on Sirius XM Patriot on Sunday evenings from 7 p.m. to 10 p.m. ET (4 p.m. to 7 p.m. PT). He earned an A.B. in Social Studies and Environmental Science and Public Policy from Harvard College, and a J.D. from Harvard Law School. He is a winner of the 2018 Robert Novak Journalism Alumni Fellowship. He is also the co-author of How Trump Won: The Inside Story of a Revolution, which is available from Regnery. Follow him on Twitter at @joelpollak.