Can you share your opinion on SOC and malpractice? Where does this NOW leave the FDA? I haven't had the time to think about this recently, but I believe the FDA is in theoretical legal jeopardy if they can't claim sovereign immunity. I would think from a Constitutional standpoint the sovereign immunity is breached by 5th and 14th Amendments.
Patients refused a prescriptions based on FDA labeling and SOC differences may NOW have legal recourse against the US Government if they are diabetic and have an event.
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