this post was submitted on 17 Aug 2023
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Politics
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As I understand the regulations, the FDA did a roundabout way of approving the drug for general use (it was originally approved under a pathway for drugs that were dangerous and had to be closely monitored by a doctor. This really was a weak spot for the FDA's case. So I think the main critique from the court being that the decision-making of the FDA was abitrary and capricious in relaxing rules to prescribe (if it was dangerous, why did they relax the rules for use during covid? If COVID necessitated an easier way to obtain it, was it dangerous enough to need the Subpart H approval in the first place?). So the way the FDA approved the drug opened them up to administrative challenge.
Do you know if that means that the FDA could just backup and do the approval process again and conclude that it does not need to follow the pathway of a dangerous drug? If it aligned with other drugs that way, then legal arguments might be moot?