> why do i need environmental review to stick a shed in my backyard??

Because cowboys make cowboy decisions, which leads to loss of lives.

"We're going to build on a flood plane, don't worry we've put in protection" turns out they didnt and the things they did made the flooding worse.

> companies have a strong incentive not release bad drugs now

Given that fentanyl exists and managed to get through, and was widely prescribed by doctors, and the whole industry setup to encourage prescription, I think thats not really true. Its not even like its that effective as a pain relief (https://www.bjanaesthesia.org/article/S0007-0912(17)37428-7/...)

Fentanyl is not a bad drug.

It's deadly *on the street* because of it's tendency to clump, meaning that your average drug dealer is not competent to dilute it properly. That's not a problem when handled by professionals.

so cowboys meet Darwin and their population drops. An alternative is a "nanny state" where every personal choice must pass regulation. This is as old as the hills, but add new abilities to monitor for compliance at scale; new orders of magnitude advantages for certain high-tech; and new amounts of money in an active and massive economic system.

Without prescribing any solution here, is it that much of a stretch to think that the FDA in practice exhibited dysfunctional characteristics in markets? With the longevity of the players and the deep pockets associated with health care, is it a stretch to see large changes to the institution as constructive in the long-run?