March 31, 2020
A statement issued March 29 by the U.S. Department of Health and Human Services (HHS) announced that millions of donated doses of hydroxychloroquine sulfate and chloroquine phosphate had been accepted into the Strategic National Stockpile. In addition, the statement announced that the Food and Drug Administration has granted Emergency Use Authorization (EUA) for the two drugs to be “prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
The HSS statement pointed out that: “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.”
The Lupus Research Alliance (LRA) thanks Sandoz, a division of Novartis, Bayer and other companies such as Mylan, Teva Pharmaceuticals and Sun Pharmaceuticals for responding to the need we voiced with pledges of hydroxychloroquine and chloroquine donations – all of which help preserve the supply for people who rely on the drug to treat lupus and other rheumatic conditions. These companies also are ramping up production to produce additional supply. In addition, pharmacy chains and state pharmacy boards have answered requests from the LRA and the rheumatology community with guidelines that also help make sure that people with lupus and other conditions continue to be able to fill their prescriptions for these important drugs.
The EUA issued for hydroxychloroquine and chloroquine is the first for a drug related to the COVID-19 response. The FDA has the authority to issue an EUA if it “determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives.”