Oct 11, 2020 - Health

Ex-FDA chief: Trump "definitely missed the window" to mass produce antibody drug

The Trump administration "definitely missed the window" to mass produce Regeneron Pharmaceuticals' coronavirus antibody drug this year, former FDA commissioner Scott Gottlieb told CBS News' "Face the Nation" on Sunday.

Why it matters: President Trump, who received the antibody cocktail after testing positive for the coronavirus, has hailed the drug as a miraculous "cure" — despite a lack of scientific evidence — and promised to distribute it to every hospital for free.

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

What he's saying: "We would have needed to take different steps in April and May to ramp up manufacturing capacity to have the drug available in larger quantities right 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'd probably need anywhere between 300,000 and 400,000 doses a month to supply it just for people who are indicated based on age alone," and he added that he and others raised the issue of ramping up manufacturing "many times" earlier in the year.
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