The FDA only require safety (and even then side-effects can occur) and efficacy. There is no requirement for an understanding of mechanism of action.
Here is a quote from Nature Medicine
"For a drug to gain FDA approval, it must be safe and show some efficacy. Because the FDA does not require any understanding of the mechanism by which a drug acts..." in an article advocating for MoA being useful to test for expected side effects.
Cell Therapy News/Articles, page-6613
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