From the Document: "To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics--drugs or biologics--for the treatment of COVID-19 [coronavirus disease 2019]. However, FDA has authorized the emergency use of two drugs: hydroxychloroquine sulfate ('hydroxychloroquine') and chloroquine phosphate ('chloroquine'). The agency has determined that based on the totality of scientific evidence, 'it is reasonable to believe that [chloroquine] and [hydroxychloroquine] may be effective in treating COVID-19,' and that when used in accord with the conditions of the emergency use authorization (EUA), the known and potential benefits outweigh the known and potential risks of these drugs. Some stakeholders--including several former FDA officials--have expressed concern regarding FDA's EUA, stating that current data regarding the safety and effectiveness of these drugs for treatment of COVID-19 are largely anecdotal and that expanding access may jeopardize research into the drug. When asked whether there is evidence that hydroxychloroquine may be effective as a prophylaxis against COVID-19, Dr. Anthony Fauci--Director of the National Institute of Allergy and Infectious Diseases (NIAID)--has said 'the answer is no' and that with respect to hydroxychloroquine as a treatment '[w]e still need to do the definitive studies to determine whether any intervention, not just this one, is truly safe and effective.'"
CRS Insight, IN11347
Congressional Research Service: https://crsreports.congress.gov/