10/08/2026
Dr. Casey Paleos recently submitted a formal written comment to the FDA regarding a question that will shape the future of psychedel*c medicine: should licensed psychotherapists be required in the delivery of these treatments post-approval?
His submission builds on the comment of colleague Dr. Scott Shannon, adding to the evidence base and challenging the narrative being advanced by certain pharmaceutical companies—that the therapy component of psychedel*c-assisted therapy is optional.
The regulatory decisions being made right now will determine how these treatments reach patients for decades to come. Read the arcle and subscribe to Casey's Substack: https://caseypaleosmd.substack.com/p/safe-and-effective-psychedelic-assisted