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FDA walks back Trump claims on COVID-19 drugs - Roll Call

Fourteen companies make generic hydroxychloroquine, according to the FDA, and Sanofi makes a branded version marketed as Plaquenil. At least 14 companies make generic chloroquine, which is more toxic than hydroxychloroquine.

CQ Roll Call asked half a dozen companies if they were in discussions with the administration to ramp up supply, but none immediately responded. 

Asked when remdesivir might be ready to come to the market, Hahn said that was proprietary information he could not share. Hahn said Gilead would supply more information to the public “relatively soon.”

But he encouraged practitioners to consider using the FDA’s compassionate use process to acquire remdesivir and treat patients. Those requests depend on the drug companies to cooperate and provide the drug, and while Gilead says it is considering requests, it appears to be prioritizing the most severely ill people. 

“Gilead is currently assessing requests on an individual basis and require, at a minimum, that the patient be hospitalized with confirmed COVID-19 infection with significant clinical manifestations,” Gilead’s website says. The company didn’t reply to questions about how many compassionate use requests it has received or fulfilled in the U.S., nor did the FDA. 

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March 20, 2020 at 03:15AM
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FDA walks back Trump claims on COVID-19 drugs - Roll Call
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