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The unintended consequence of the onerous FDA approval process is that only a few extremely large players have the resources to develop and bring new drugs to the market. Therefore they need to make a lot of money back to cover their costs.

On the other hand, in earlier times we had a lot of drugs that were in the "snake oil" category, making a lot of claims but doing nothing at all (or that were actually harmful).

But in a bid to mitigate risk (from their shareholders) big pharma effectively outsources lots of compound discovery to biotechs. This has helped create a large pool of biotech startups that never intend to run a phase 1 study but instead prepare for acquisition upon promising preclinical.

IMO the only criteria should be safety. Medicine doesn't have to work for everyone to be useful for a lot of people.

A great many drugs are grossly unsafe if you even minorly exceed the clinical dosage threshold, but are still regularly used by people because we haven't found better replacements.

A much larger set of drugs fall into a gradient of "as far as we can tell you'll just excrete it if you take too much" to "it's probably not _good_ if you unnecessarily take it, but it won't really be detectable in 4 weeks" to "oh god why would you ever prescribe that".

So if we were purely grading on safety, we'd be out quite a lot of pharmacology.

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