President Trump announced Thursday that the Food and Drug Administration would soon introduce new coronavirus therapies.
Trump announced that the FDA is “slashing all of the red tape” to get medicines on the market “as fast as we can get it.” Anti-viral therapies are still in early clinical trials, but the Trump administration is aiming to speed up the process.
“What the FDA is doing is incredible,” Trump said. “I’ve directed the FDA to eliminate outdated rules and bureaucracy. … We have to remove every barrier.”
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The FDA is considering a drug used to treat malaria called Chloroquine, which researchers think could prove an effective treatment for the coronavirus. Trump said it has “tremendous promise based on results and other tests.” Another drug that could be used to treat the coronavirus is Remdesivir, an antiviral made by Gilead, the manufacturer behind PrEP drugs to prevent HIV infection.
“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,” said the FDA commissioner, Dr. Stephen Hahn.
Though the drugs have been approved for other specific treatments, the FDA is working to see if expanded use is possible.
“We want to do that in a setting of a clinical trial, a large pragmatic clinical trial,” Hahn said.
The FDA is also considering a treatment that consists of transfusing blood plasma from a person who has been cured of the coronavirus into a patient who is still infected. The therapy, called convalescent plasma, is still under investigation and could be another three to six months away.
“What’s also important is not to provide false hope, but to provide hope,” Hahn said.
“Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective,” he said.
Hahn added that vaccines are in early testing phases and will likely be in trials for at least another year. However, he said development on vaccines is “exciting work,” and it’s happening in “record time.”
“This is a continuous process; there is no beginning and end to each of this,” Hahn said. “We’re pushing this through.”
