I have concluded that the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19 when administered as described in the Scope of Authorization (section II) meet the criteria for issuance of an authorization under Section 564(c) of the Act, because:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products; and
3. There is no adequate, approved, and available alternative to the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID19.
Denise M. Hinton
Food and Drug Administration