The United States Food and Drug Administration has now pulled an emergency authorization that permitted the use of hydroxychloroquine and chloroquine for treatment of the novel coronavirus.
The FDA decided to revoke its decision because the drugs, used to treat malaria, do not meet the "the statutory criteria" for emergency use authorization as there is no evidence that confirms the effectiveness of the drug in treating COVID-19.
In a letter to Gary Disbrow of the Biomedical Advanced Research and Development Authority on Monday, FDA chief scientist Denise Hinto explained the revocation, writing "FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks."
"Accordingly, FDA revokes the EUA for emergency use of (hydroxychloroquine) and (chloroquine) to treat COVID-19," Hinton continued in the letter, "As of the date of this letter, the oral formulations of (hydroxychloroquine) and (chloroquine) are no longer authorized by FDA to treat COVID-19."
Just last month in an open letter published by FDA commission Dr. Stephen Hanh, Hanh defended the agency’s decision to issue the emergency authorization. "This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies," Hanh wrote in the letter.
Hydroxychloroquine has long been advocated for President Trump, who shared he himself uses the drug and even recommended the drug to the public, despite warnings from medical experts.