The White House has urged the US Food and Drug Administration (FDA) to reinstate its emergency use authorization (EUA) for the anti-malaria drug, hydroxychloroquine (HCQ), for COVID-19 treatment.
Weeks ago, the FDA revoked the EUA that allowed for HCQ used to treat certain hospitalized patients with COVID-19, after the agency determined that the drug was “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA”, while highlighting potential serious side effects, reports Xinhua news agency.
“White House trade adviser Peter Navarro is leading a Trump administration effort to demand the FDA reverse course,” the Washington Post said in a report on Monday.
“A reversal (on HCQ) would be widely seen as bending to the political will of the White House,” the Washington Post quoted Steven Joffe, a medical ethicist at the University of Pennsylvania, as saying.
As the agency will take the lead in approving a vaccine for the coronavirus in the country, “health experts say it is important for the agency, which was criticized for its initial decision to okay hydroxychloroquine in March, to guard its credibility as it prepares to make these landmark decisions for a public sometimes sceptical of vaccines”, the report warned.
The World Health Organization has vacillated on HCQ use, stopping trials using it, then reinstating it and again dropping it.
Last month, the US National Institutes of Health (NIH) announced that it has halted a clinical trial to evaluate the safety and effectiveness of HCQ as it determined that while there was no harm, the drug was very unlikely to be beneficial to hospitalized patients with COVID-19.