Imagine that there were no FDA Iron Curtain and doctors prescribed afobazole because "the paper was good" (or more likely because the money was good). Then people taking this drug got hospitalized left and right (or - shudder - found dead) because of side effects. FDA could not do anything to protect her dear US citizens. She couldn't sue the manufacturer or ask them to do further research or impose black box warning…
Its hubris, American regulatory groups sticking their fingers in the affairs of other countries. And its beyond their charter to try to regulate what Americans do; they're supposed to regulate what American manufacturers do, not private citizens?