MDMA and Psilocybin FDA Approval: What to Expect and When

Michael Pollan's read: both MDMA and psilocybin are close to FDA approval. Psilocybin is coming through Compass Pathways. MDMA is coming through the company formerly called Lycos, now Resilient, which got a rejection, resubmitted with additional data, and is back in review.

Both are now on a fast track under an executive order that started as an ibogaine initiative and got broadened at the White House level to cover other psychedelics with stronger clinical backing. Pollan credits Joe Rogan calling President Trump as part of what moved the political needle, and says the administration is doing the right thing for the wrong reasons. Rick Doblin of MAPS, who spent years deliberately cultivating veterans groups and the political right, deserves credit for making the moment possible at all.

Pollan's caution is worth taking seriously. He draws the comparison to cannabis: broader legal access exposed addiction risks and psychosis links that weren't visible in earlier, narrower use. His concern is that approval will be a genuine public perception shift — substances millions of people have filed under "dangerous drugs" get officially reclassified as medicines, and a large wave of people with no prior interest will start asking whether these treatments apply to them or someone they love. That scale of use will surface contraindications that clinical trials missed.

He's specific about who should stay away: people with predispositions to psychosis and people with certain heart conditions. Public education, he says, will need to move fast to keep up with demand.

Michael Pollan says MDMA and psilocybin are both close to FDA approval, with psilocybin coming from a company called Compass Pathways and MDMA from a company formerly called Lycos (now Resilient), which was turned down once and has resubmitted with additional data. He says both are now on a fast track under an executive order that was originally written for ibogaine but was broadened at the White House level to include other psychedelics with stronger clinical data behind them. He attributes the political momentum in part to Joe Rogan contacting President Trump, and says the administration is doing the right thing for the wrong reasons.

Pollan warns that approval will be an earthquake in public perception — officially reclassifying substances many people considered dangerous drugs as medicines — and that millions of people who have never thought about psychedelics will start asking whether these treatments are for them or their family members. He draws a cautionary comparison to cannabis: wider use has revealed addiction risks and psychosis that were not apparent earlier. He says people with predispositions to psychosis or heart conditions should avoid psychedelics, and that significant public education will be needed. He also credits Rick Doblin of MAPS with years of deliberate outreach to veterans groups and the political right as essential to reaching this moment.