There are two kinds of errors an FDA type agency can make:

A: Approve a drug that turns out to be a "cure worse than the disease", and shouldn't have been approved.

B: Not approve a drug that would have cured many sick and/or saved a lot of lives.

You can never fully know beforehand which error a decision will have. So the FDA will always gamble a bit in their decisions.

And here is the gigantic problem:

With a type A error, patients taking the new drug dies, there is an uproar in the media, the agency takes a big beating, and careers are ruined.

With a type B error, a lot of people who could have been saved dies. But that is no change from before, no one notices, and the careers of FDA officials are unharmed.

Given these incentives, it is not surprising that the FDA overwhelmingly errs on the side of type B errors. It's hard to compute, but the number of lost lives from this is probably in the millions since the 60s.

In type A, people have a choice. They could be informed there is a risk. In type b, they have no choice.

And who provides the neutral informed accessible information? and there's the rub with modern society. No one could possibly be expected to be an expert in every field and sub field.

Drugs are prescribed by a doctor, who should be an expert in this exact field.

And you hear all the time about getting test you don't need and all kinds of other conflicts of interest.

And clearly the FDA has a bias on not making a decision that could be wrong. They lose nothing by delaying, and lose a lot by approving the wrong drug. So what happens, everything takes longer, drives up costs, and delays treatment -- they have no incentive to deal with the problems they create.

That was Thalidomide and it was legal in the US.

At any rate my point wasn't that the FDA only makes bad decisions.

My point was that it has a monopoly on approving new medicines and therepeutics, and it is not at all clear that this monopoly is a net good or net bad. (And it's impossible to measure because we can't tell how thing would have played out for things that never happened)