"But what this says is that EUA products, no matter what happens, no matter how adulterated and full of these dangerous contaminants, they shall never be deemed adulterated or misbranded by the FDA." (2/2) pic.twitter.com/Col8mcDAnQ
— HealthRightsMA (@HealthRightsMA) February 13, 2024
Everybody assumed that these vaccines were going through the Expanded Access Use pathway. Turns out they were not. They are a completely different category of product that the federal government has created . . . called EUA, Emergency Use Authorization countermeasure, and this category only exists under Public Health Emergency or Prep Act declaration by Health and Human Services Secretary. So under this particular category, they're regulated by a completely separate section of Food and Drugs and Cosmetics Act [FDA] that says that "everything that's illegal for normal pharmaceuticals is now legal as long as Prep Act window remains open for them. And as we know for COVID-19, the Prep Act window is open until December 2024.
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