The approval allows doctors freedom to prescribe the antiviral earlier. But it comes less than a week after the agency approved use of convalescent plasma without published scientific support, fueling concerns the agency is yielding to political pressure.
“It seems to be a pattern of approval without science, without data, without evidence,” said Dr. Eric Topol, vice president for research at Scripps Research.
In May, the FDA issued an emergency use authorization for a drug called hydroxychloroquine, which was strongly promoted by President Donald Trump. There was little data supporting the approval, and the FDA reversed its decision in June after mounting evidence suggested the drug did more harm than good.
For decades the FDA has set the world’s standard for drug approvals. Although it has been criticized before for yielding to political pressure, those who follow the agency said they have never seen such consistent politicization.
Topol and others said they are particularly concerned about the FDA because the public needs to have faith in the agency that will approve any COVID-19 vaccine.
Topol said he fears it may be too late to preserve the FDA’s credibility. “For the public that’s paying attention, it’s already been sacrificed,” he said.