The Old FDA Approach is Over

MAKARY: “I think the most dangerous thing you can do in public health is demand something of a young, healthy individual.”

Dr. Marty Makary is making it clear: the old FDA approach is over.

A new era is here.

“Our job at the FDA is, and this is a charge by Congress, is to look at applications that are submitted to us and determine what is safe and effective.”

He pinpointed exactly why trust was lost.

“I think there was some lost trust in the FDA when there was a new policy that basically said for a young, healthy 15-year-old boy, we were going to rubber stamp a Covid vaccine without a clinical trial every year in perpetuity.”

“And I think we're saying we're going to be less absolutist when there's no evidence.”

Makary drove the point home with a clear warning.

“I think the most dangerous thing you can do in public health is to demand something of a young, healthy individual when the evidence is just not that supportive for a new virus that creates a new protein and a new vaccine that creates a new protein, where we haven't had a clinical trial in over four years.”