Field Notes #6: Dispatches from D.C. as Three Psychedelics Land at FDA

Welcome to our sixth Field Note. As a reminder, Field Notes are timely, candid voice notes from our Founder and Editor, Josh Hardman, that give our Pα+ readers a pulse on recent developments in psychedelic drug development, policy, and access.

In this Field Note, Josh shares notes from a recent trip to Washington, D.C., where he attended BrainFutures’ Frontiers of Mental Health and Recovery. Topics include:

• Three psychedelic NDAs now with FDA and views on psilocybin packages
• ICER’s review of Compass’ psilocybin, and what its Spravato precedent suggests
• CDER Director Mike Davis on FDA’s role (and its limits) in psychedelics
• Washington’s shifting politics, from the midterms to FDA leadership
• This week’s HHS ibogaine announcement, NIMH’s funding opportunity, and Delix’s J&J-backed raise

A transcript is available below.