So again I think real medicine - my definition of real medicine is one where the error rate and speed of responsiveness is such that deaths are almost never from all causes - isn't compatible with the FDA.

At a certain point you need the AI system and doctors overseeing it to do what needs to be done and theres no way to regulate it by chemical compounds used. You would need to use anything and everything, often synthesizing what you need right before use. Not to mention gene edits would be patient specific done by a learning algorithm that changes by the hour.

One way around this would be to offer the treatment in other jurisdictions. If the group doing this has an AGI and singularity grade robotics it's going to actually work. Once enough wealthy people are restored you'd start a political campaign to have the FDA abolished and replaced with an outcome based agency.

There could amusingly be an edge period, where medicare is tired of paying nursing home and hospice bills so it sends the patients to Antigua or whatever to be regenerated and legally no longer eligible for Medicare. But the FDA is still fighting it's abolition and USA hospitals are still running and filling their morgues with their mistakes.