Former FDA chief: Trump ‘definitely missed the window’ to mass-produce antibody drug

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The Trump administration “definitely missed the window” to mass-produce Regeneron Pharmaceuticals’ anti-coronavirus drug this year, former FDA commissioner Scott Gottlieb told CBS News’s “Face the Nation” on Sunday.Why is this important: President Trump, who received the cocktail of antibodies after testing positive for coronavirus, hailed the drug as a miraculous “cure” – despite a lack of scientific evidence – and vowed to distribute it free to all hospitals .

  • The president is now seeking emergency use authorization for the drug from the FDA.
  • Leonard Schleifer, PDG of Regeneron said earlier on the show that the company currently only has sufficient doses for 50,000 patients. More than 50,000 Americans have tested positive for COVID-19 each of the past three days.

What he says: “We should have taken different steps in April and May to increase manufacturing capacity so that the drug was available in larger quantities now,” Gottlieb said.

  • “It’s too late for this year. I think we could still take steps to do it for 2021, but we’re stuck with the doses we have. “
  • Gottlieb said: “You would probably need 300,000 to 400,000 doses per month to provide them only to the people indicated only by age”, and added that he and others had raised the question of the production ramp-up “several times” earlier in the year.



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