When red tape makes drug development and testing impossible, as it did here, the system has ceased to benefit humanity and is causing nothing but stagnation and long-term suffering (by virtue of holding back potentially life-improving or life-saving treatments.)

Enabling medical progress is far more important in the long term for our species (and to reduce suffering) than adding the umpteenth killswitch/safeguard for an ostensibly safe medicine.

But FDA regulators have no incentive in the positive direction, only in the negative direction. The more drugs they deny, the less likely they can be blamed if something goes wrong; the more requirements they add, the more secure their careers - humanity's medical progress be damned.