FDA submission
Not yet submitted.
This page will publish the comment in full on the day it is filed, dated and versioned. Until then, here is what it will say and what has to happen first.
STATUS: DRAFT OUTLINE · NOT FILED
Why this page is empty
A comment filed in the name of community expertise, before any community member has agreed to put their name to it, would be the exact thing this project exists to prevent. The outline below needs review by the Founding Circle members whose credibility it would draw on, and by regulatory counsel, before it is filed.
The dates are fixed and public. What goes in the comment is not.
The docket
- 21 AUG 2026Deadline to request an oral presentation slot
- 14 SEP 2026Public hearing · FDA White Oak · hybrid
- 05 OCT 2026Deadline for written comments
What the comment will say
Name the gap. No federal mechanism brings practitioner or community expertise into psychedelic drug regulation, unlike Oregon's statutory advisory board.
Name the risk. The 2024 Complete Response Letter shows what trial design costs when it underestimates participant psychology and community dynamics.
Name the expertise. Three decades of harm-reduction and integration practice, documented in published ethics codes and in peer-reviewed research on peer support and integration outcomes.
Recommend. That the FDA convene or formally recognise a practitioner and community advisory mechanism comparable to Oregon's, and treat wraparound and peer-support services as part of the safety case for approval rather than an optional addition.
This outline has not been submitted. It needs review by the Founding Circle members whose credibility it would draw on, and by regulatory counsel, before anything is filed.
If you want a say in it
The comment should carry more than one voice. If you have done harm-reduction, peer-support or integration work and think this is worth signing — or worth arguing with — say so before it is drafted.