Former FDA leaders decry emergency authorization of malaria drugs for coronavirus

The recent Food and Drug Administration (FDA) emergency use authorization (EUA) for two malaria drugs to treat COVID-19, based on thin evidence of efficacy, has jeopardized research to learn the drugs’ real value against the pandemic coronavirus, say former agency executives under President Donald Trump and former President Barack Obama. They also charge that the 28 March EUA for chloroquine phosphate and hydroxychloroquine sulfate undermines FDA’s scientific authority because it appeared to be a response not to scientific evidence, but to fervent advocacy of the drugs by Trump and other political figures. FDA has multiple mechanisms to allow the use of unapproved, experimental drugs for small numbers of desperately ill patients outside of clinical trials. Because chloroquine and hydroxychloroquine are approved for malaria, doctors could prescribe them “off label” for COVID-19 patients even without the EUA. Since Trump first endorsed the drugs on 19 March, however, shortages have been reported, depriving some people with autoimmune disorders such as lupus who also depend on hydroxychloroquine. The EUA will immediately add tens of millions of doses of the drugs for distribution to hospitalized COVID-19 patients through health care centers.