What the psychedelics executive order actually does (and doesn't)

A client recently told me that psychedelics “got approved in April”. They didn’t. This is a great example of how a supposed win for access can be structured to sort by class.

The Executive Order did four things:

1. Faster FDA review for Breakthrough-designated psychedelics,
2. A Right to Try pathway for investigational compounds with ibogaine named specifically,
3. $50 million through ARPA-H, and
4. A rescheduling review that only kicks in after an approval that hasn’t happened.

Nothing was approved or rescheduled.

IMO, Right to Try was never going to be distributed evenly. Using it means finding a physician willing to supervise off-label treatment, a manufacturer willing to provide the drug, usually paying cash, and often traveling. That is the structure of the pathway. Any route that requires resources can only be used by people who have those resources. When a scarce, unproven treatment is routed this way, the benefit concentrates where healthcare inequities already exist.

FDA approval is slower and more rigorous because it requires evidence. However, neither Right To Try nor FDA approval will distribute access beyond those who can already afford access.

None of this is abstract for clinicians. It is the same question underneath every attempt to build something different: does this field expand access, or just build a nicer on-ramp for people who already had it?

I wrote up what the order does and does not do, and who benefits: What the executive order actually changes, and who it leaves out.​

Peter

P.S. If a client brings you this headline and you want a fuller frame for that conversation, including where power and consent come in when someone arrives hopeful and under-informed, I created Psychedelics and the Therapeutic Frame (3 CE hours) for this moment.