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We found out that the FDA in the prior administration had approved gene therapy in Americans whereby the cells were gene edited in Chinese labs. | |
Literally, the cells were taken from Americans, sent to Chinese labs where they were genetically altered and then shipped back to the U.S. where those cells were infused back into American patients. | |
When we found out, we said, let's put a halt on this. | |
So there was a lot going on. | |
But I think also the agency needed to refocus its mission on delivering a stamp of safety and efficacy on drugs and devices and ensuring a safe food supply. | |
We have inspectors, law enforcement officials, thousands of scientists, and I think this is a good time for us to rehone and refocus on that core mission of the FDA. | |
Well, the FDA sat on data on myocarditis risk with the mRNA COVID vaccines in young men. | |
They literally slowwalked any action on that data. |