Well, I agree with you that it's slower here and I also feel your frustration with the pace of research. But, in Europe, they only have to show safety for approval. In the US they also have to show efficacy as well as safety. So, the FDA is using stricter criteria.
In most cases, yes, it is *better* to use efficacy as a guideline because why take an expensive new painreliever if 2 aspirin works just as well. However, neither safety or efficacy measures really get at a quality of life evaluation. Maybe(*) smart insulin will not reduce A1Cs or complications much compared to current MDI regimes. So it comes out of the study not looking safer or more effective. The FDA seems to struggle with cases where the improvement in the patients quality of life (less shots, eating more normally, etc.) is the real win because any way to monitor that is becomes at least somewhat subjective. So I hope smart insulin is on its way and I hope the FDA gets some common sense before it gets there.
*Just to note, my example is not because I know anything about the safety or efficacy about how smart insulin actually works and how it will go down at the FDA, just my imagination of why it could get stuck in the FDA for quite a while.
I'm not sure whether the FDA's approach is "better" (as you said) or worse. As you implied, it seems to depend somewhat on the device or medication. But, what I don't like is the anti-FDA tone in a lot of the T1 online community, including in this thread. The speed of research relates to a lot of things including science, funding, and the approval process. But, I feel they have good intentions and are not purposefully trying to delay a cure, even if they may be misguided. I know 2 of the endos who work over at FDA, and one of them has T1. Both feel they're doing their best to make sure the approved medications are safe, even if we all wish it would go MUCH faster.
And PS, I agree that everyone that I'd LOVE to see this smart insulin tomorrow, lol!