Sounds like a fixable problem.

If you’ve read the stories on some of these foreign manufacturers, you might reconsider trying to bypass the FDA inspection requirement.

Here’s just the first hit I saw on Google, there have been quite a few exposés on the topic.

https://www.npr.org/sections/health-shots/2019/05/12/7222165...

Exactly. Instead of spending 10Bn on R&D, spend 10Mn on lobbying.

How exactly would you fix it?