Why are Standards So Lax on Covid Drugs Approval?

Vinay Prasad

Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet.

First, consider that EUA ( emergency use authorization ) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that is dire, with few available options. That’s the justification for lower standards, including acceptance of surrogates.

Next, consider that COVID-19 is a life-threatening illness in an older person, for instance someone over the age of 80. For an older person, it rivals cancer or heart disease.

But also consider that COVID-19 is a flu-like illness for most children, particularly in the era of Omicron. It would be incorrect to say children have ever faced an ’emergency’.

Now think about what regulatory experts have said for years. We should be cautious with accelerated approval. We should use it sparingly, and when appropriate. We can’t use accelerated approval for high blood pressure.

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