The fact is that with insulin the regulation issues comes from the patchwork system of healthcare the US developped through political concesssionns and lobbying from private firms, which makes the developpment and the subsequent commercialization expensive relative to Europe where centralized national bodies negotiate with the pharma companies.
Regulation can be good or bad, in our era it is ineffective because politicians are boomers disconnected from the issues or in the EU a pseudo-technocratic (not really listening to technocrats recommendations) body far from reality
This series of posts is a nice forray into managerialism (the source of many regulation issues) https://baazaa.github.io/2024/10/16/managers_p1.html