The FDA is allowing two drugs to be used for 'compassionate use' to treat the coronavirus. Here's what that means.
- During a Thursday press conference, President Trump said the drugs chloroquine and remdesivir would soon be available to treat people with COVID-19.
- Food and Drug Administration Commissioner Stephen Hahn clarified the drugs would actually be available only for "compassionate use."
- The term "compassionate use" refers to using a drug off-label when other treatment options are not available.
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During a Thursday press conference, President Trump said the drugs chloroquine and remdesivir would soon be available to treat people with COVID-19, the disease caused by the coronavirus. FDA Commissioner Stephen Hahn later clarified Trump's comments, saying the drugs would actually be available only for "compassionate use."
Compassionate use refers to using a drug off-label when other treatment options aren't available.
Anecdotal reports have suggested the two drugs help some people recover from COVID-19. But neither chloroquine, a generic anti-malaria pill that was approved in the US in 1949, or remdesivir, an antiviral developed by Gilead Sciences, have completed clinical trials for use with COVID-19, so they are considered compassionate use options for the time being.
At the press conference, Trump said both remdesivir and chloroquine were FDA-approved for use and would soon be available through prescriptions. But since both drugs would be used off-label, they aren't actually FDA-approved for treating COVID-19.
The FDA didn't respond to Business Insider's request for comment.
Usually, compassionate-use drugs are reserved for terminally ill patients who have no other treatment options. If a patient is part of a compassionate use program, doctors are allowed to give them these treatments despite the fact they have yet to be proven safe or effective at treating a condition off-label.
To better understand if the general public can benefit from remdesivir and chloroquine, Hahn said doctors at Gilead are testing the drugs in compassionate use programs right now.
They expect to have results in April from tests now being done in China, and will then be better able to decide if the drugs should be distributed on a larger scale.
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