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1 1 (May 27, 2020)

handle is hein.crs/goveahe0001 and id is 1 raw text is: Congressional Research Service Treatment of COVID-19: Hydroxychloroquine and Chloroquine Updated May 27, 2020 To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics-drugs or biologics-for the treatment of COVID-19. However, FDA has authorized the emergency use of three drugs, including two drugs that have been approved by FDA for other uses: hydroxychloroquine sulfate (hydroxychloroquine) and chloroquine phosphate (chloroquine). The agency authorized the emergency use of both drugs on March 28, 2020, determining 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. On April 24, 2020, FDA issued a drug safety communication warning against the use of these drugs for treatment of COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Further, the National Institutes of Health (NIH) treatment guidelines on use of antivirals for COVID-19 state that [t]here are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19 and recommend against using high- dose chloroquine for the treatment of COVID-19. FDA Regulation of Drugs FDA, under the Federal, Food, Drug, and Cosmetic Act, regulates the safety and effectiveness of drugs. Generally, before a new drug may be marketed in the United States, the manufacturer must submit to FDA for approval a new drug application containing evidence of the drug's safety and effectiveness, as derived from clinical studies. Under certain circumstances, such as a public health emergency, FDA may authorize the use of investigational, unapproved therapies. On March 28, 2020, FDA authorized the emergency use of hydroxychloroquine-approved as an anti- inflammatory and antimalarial-and chloroquine-approved as an antimalarial. Neither drug is FDA- approved for treatment of COVID-19 (see Table 1), and the drugs' mechanisms of action are not entirely known. Congressional Research Service https://crsreports.congress.gov IN11347 CRS INSIGHT Prepared for Members and Committees of Congress