US President Donald Trump on Thursday called on the FDA to cut "all of the red tape" in order to help get therapies against COVID-19 on the market. "I have directed the FDA to eliminate rules and bureaucracy so work can proceed rapidly," he said, adding "we have to remove every barrier."
Trump also wants the FDA to see if it can expand the use of chloroquine, a drug already used to prevent and treat malaria, for patients with COVID-19 infections. He suggested that the drug will be made available by prescription "almost immediately," noting that "it's been around for a long time, so we know that if things don't go as planned, it's not going to kill anybody." However, an FDA spokesperson clarified the drug had not been approved for use in COVID-19 patients.
Meanwhile, the US President also described Gilead Sciences' experimental antiviral remdesivir, which was initially developed for Ebola, but is now undergoing testing as a potential therapy for COVID-19, as being "essentially approved," although he did not elaborate.
Following up on Trump's remarks at a press briefing, FDA Commissioner Stephen Hahn indicated that the agency is working to see whether expanding the use of existing drugs, such as chloroquine, to treat COVID-19 is possible. "We need to make sure that the sea of new treatments will get the right drug to the right patient at the right dosage at the right time,” he said, adding "we want to do that in a setting of a clinical trial, a large pragmatic clinical trial."
Earlier this week, a report in The Wall Street Journal cited a senior US government official as saying the White House considered issuing an executive order to greatly expand the use of investigational drugs against COVID-19, but was met with objections from the FDA.
Aside from chloroquine, other currently marketed drugs thought to have potential efficacy against COVID-19 include Roche's Actemra/RoActemra (tocilizumab), and Sanofi and Regeneron Pharmaceuticals' Kevzara (sarilumab), as well as Fujifilm's Avigan (favipiravir). On Thursday, findings published in the NEJM indicated that the addition of AbbVie's Kaletra (lopinavir/ritonavir) to standard care was no better than standard care alone at reducing the time to clinical improvement or cutting death rates among seriously ill patients with confirmed SARS-CoV-2 infection.
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