Comment: Without the FDA to approve

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In reply to comment: I had the same thought. (see in situ)

Without the FDA to approve

Without the FDA to approve drugs drug companies wouldn't have protection from tort.

Without protection from tort they would have to have underwriting against liability.

The underwriters only make money if they charge more for insurance than gets paid out in a period. It's their job to know the risk, if they fail they lose money.

The drug companies in turn want the cheapest underwriting, to get the cheapest underwriting they will have to comply with safety standards.

The FDA is supposed to ensure safety, but since they can't lose money, they actually have incentive to let people be harmed. When people are harmed they can call for a greater budget.

Private underwriters also do not have as much incentive to deny new drugs, and in any case have no power to literally interdict them.

In a free market you would be free to try new drugs. Either on your own or with your doctor's recommendation. If you try something that is not insured, like if you are dying and have tried everything else, well that is your choice.