[LeifCarrotson]

The presence of a handful of scandals with huge settlements does not need that we need more FDA.

We need less. Much less. At the very least we need to separate the concept of it being legal for doctors to prescribe a drug and mandatory for insurance to pay for a drug.

Right this minute, hundreds or thousands people are actively suffering and dying from rare diseases because it's ludicrously expensive to bring new medicines to market. We place blame - we file lawsuits - on someone who sells a drug that doesn't work or that causes harmful side effects, but we sag our shoulders and shake our fist at the uncaring universe when someone dies of a disease that wasn't worth $200,000,000 to force a guaranteed-safe treatment through FDA approval.

A medical review and approval process that must never, ever allow a single bad outcome through on pain of terrible, multi-billion-dollar scandals is guaranteed to cause bad outcomes, because not allowing good things to be approved is a bad outcome.

[photochemsyn]

There's an easy fix for these rare disease cases, but it's not one the pharmaceutical industry likes - open source drug development with clinical trials run by research agencies themselves.

This would mean such drugs would not be exclusively licensed by any private entity, but instead could be manufactured and distributed by anyone that met quality standards, greatly reducing prices for consumers. See Linux etc.