GP is right that monopolization and vertical integration (as you allude to in your comment) is much more salient.
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The main expense is proving your drug works. It’s not really fair to describe that as incurred by FDA regs.
And in any case: drugs are (surprisingly) not a major driver of healthcare costs in the US.
The things that are uniquely costly in American healthcare are administrative overhead and doctors + nurses.
Go read KFF reporting on it.
GP is right that monopolization and vertical integration (as you allude to in your comment) is much more salient.