In case helpful to this discussion here's a review of "the FDA process":
-There are FDA in-house career experts, facts-based reviewers. Everything is documented.
-They follow a set of review procedures worked out between academics and industry at conferences, and that consensus depends on peer-reviewed papers with much of the facts on the drug's safety/efficacy being presented at many conferences with open discussions.
-The FDA reviewers' objective analysis is presented to an external panel of academic peers, where industry conflicts are minimized.
-That external committee votes, and the head of the FDA and White House impartially follow the vote of those external committees.
China and Europe regulatory authorities to this day have followed this FDA process, showing it has worked.
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