Physicians traditionally have had unlimited authority to prescribe FDA-approved medications for any purpose as long as they explain the risks and benefits to their patients. Suddenly, the AMA and its industry patrons and captive regulators moved to limit the doctor’s authority to treat patients. FDA has no authority to regulate the practice of medicine. As Stephen Hahn, FDA’s last Commissioner (no one has been appointed to the role since he left) pointed out in October 2020, off-label prescribing is between a doctor and his/her patient.
