1 1 (April 20, 2020)

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Treatment of COVID-19: Hydroxychloroquine

and Chloroquine



April 20, 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 two
drugs: hydroxychloroquine sulfate (hydroxychloroquine) and chloroquine phosphate (chloroquine).
Th, agency has downrincm.d 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. Somc stakeholdcrs ------ inch diag several former
FDA officials -----have espressed concerm 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 -c stiil aced to do the definitive sttidics to
detemrinlne whether any inten ention nol just this one, is truly safe and effective.

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 authori ed ibe ernergoncy usc 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
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