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Home > News > Pharma News > Former FDA chief says U.S. 'too late' to mass produce COVID-19 antibodies

Former FDA chief says U.S. 'too late' to mass produce COVID-19 antibodies

2020-10-15

Regeneron's antibody blend could get emergency approval quickly within days of President Donald Trump's standout COVID-19 treatment. But will there be enough supply to meet this year's demand if it gets there, and the former head of the FDA warns that that ship has sailed.

Former FDA Commissioner Scott Gottlieb said that with Regeneron seeking emergency use authorization for the cocktail, it's "too late" for drugmakers to scale up production to produce enough antibody doses to meet this year's demand.

On CBS's Face the Nation, Gottlieb predicted that the U.S. would need to produce 300,000 to 400,000 antibody treatments per month to keep up with continued demand for what he called a "potentially difficult fall and winter.

Regeneron CEO Len Schleifer noted earlier in the show that the company has only about 50,000 courses in stock, but is working to supply 300,000 courses to the U.S. in the coming months as part of a $450 million contract it signed in July.

Gottlieb said, "We will need to take different steps in April and May to ramp up production capacity in order to have a greater number of drugs available now." "It's too late this year. I think we can still take steps to do that in 2021, but we're still helpless,"

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