FDA’s authorization of malaria drugs for COVID-19 looks like political science
Editor’s Commentary: Why FDA's authorization of hydroxychloroquine and chloroquine for COVID-19 is bad for patients
FDA’s decision to grant Emergency Use Authorization for hydroxychloroquine and chloroquine to treat COVID-19 was unnecessary and unwise.
The EUA was unnecessary because the drugs are approved in the U.S. to treat malaria and for other uses. Physicians who believe the evidence for safety and efficacy outweighs the risks can prescribe either drug for COVID-19 on an off-label basis.
FDA can -- and has -- approved clinical trials of the drugs to treat COVID-19.
The main practical effect is that the EUA provides liability protection to physicians who prescribe and hospitals that administer the drugs. More importantly, it will be interpreted as a statement by FDA that the drugs should be used to treat COVID-19.
FDA’s action creates two sets of problems: the potential for harm to patients who will receive