A Note from the Editor

This week, I shared my Dispatch from D.C., which reflects on my time speaking with lawyers, lobbyists, and advocates, but also agency staffers, drug developers, and well-connected individuals in an attempt to take the temperature on psychedelics among those who might shape the field’s future.

There is significant tumult not only across U.S. politics and the regulatory apparatus, but also within the psychedelics field itself, which does not appear to have landed on a clear or coordinated ‘ask’. But beneath the noise, there appeared to be a quiet confidence among some that multiple FDA approvals of psychedelics are close at hand, with as many as three possible over the next 18 months.

The day after that piece was published, STAT reported that the FDA will only expect one Phase 3 trial before considering a new drug for approval. While many drugs already receive approval on the basis of one pivotal study, psychiatric drugs are often put through two or more Phase 3 trials. In our latest Bulletin, I cover what this could mean for the psychedelics field.

We also cover the Freedom to Heal Act, which was introduced this week by Senators Cory Booker (D) and Rand Paul (R). It aims to ‘fix’ what its backers view as a ‘gap’ in federal Right to Try law that effectively excludes Schedule I substances, including psychedelics. Advocates are flying in to D.C. early next week to drum up support.

Outside of D.C., longevity enthusiast Bryan Johnson’s live-streamed ingestion of psilocybin mushrooms last Sunday generated buzz early in the week. While some applauded the online event as a laudable move to reduce stigma, others poked fun at the spectacle.

Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.

Josh Hardman
Founder & Editor