The problem isn't "should we have regulation at all," but rather what is the right level of regulation. It is quite possible that the current burden of proof is too high in many cases. If drugs were made more broadly available sooner, it would likely save many lives. But also it would also likely cost some. Do we currently use the correct threshold?

There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US.

I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.

Perhaps it's a situation where there is no outcome where the barrier to entry is too high for bad actors while simultaneously being low for good actors.

The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing.

Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.