‘Sounds great. Want FDA approval? Let’s do it.’
What to make of this weekend's historic Executive Order on psychedelics
This weekend, President Trump signed an Executive Order (EO) to accelerate access to psychedelic drugs. President Trump declared:
It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.
This was, I believe, the first time a US president has ever publicly mentioned psychedelic drugs. The psychedelic movement could not have asked for a warmer endorsement from the president - he even asked: ‘can I have some?’
The Executive Order emerged from a text from podcaster and comedian Joe Rogan asking Trump to support psychedelic research, following a podcast episode earlier this month with Bryan Hubbard and Rick Perry of Americans for Ibogaine. Rogan said Trump instantly replied: ‘Sounds great. Want FDA approval? Let’s do it.’
At that, the psychedelic lobby sprang into action, with Health and Human Services (HHS) ‘psychedelic czar’ Matt Zorn writing the Executive Order in a few days, and a press conference hastily arranged in the White House for Saturday the 18th.
This was a moment created by Bryan Hubbard and Joe Rogan, and it created some big wins for the Americans for Ibogaine NGO that Hubbard founded. The EO approves the first Investigational Drug Application for ibogaine, according to the FDA’s Marty Makary. HHS also committed $50 million to support state psychedelic initiatives, which I think will go to the Texas Ibogaine Initiative. And the EO gives the president’s support to Right To Try access for ibogaine and other psychedelic drugs, so that military veterans don’t have to go to Mexico to receive ibogaine. That’s a good idea as Trump’s war on the cartels hots up.
But the biggest winners in the short term are psychedelic drug companies poised to seek FDA approval in the next 12-24 months. FDA head Marty Makary said three psychedelic companies would receive National Priority Vouchers this week and he would make decisions on them and other psychedelic applications ‘as soon as they’re on my desk’. Makary and Trump’s comments in support of psychedelics lifted the entire sector on the stock market this week - stocks like Compass, AtaiBeckley, Delfinum, GH Research and Cybin saw their stock prices rise by around 15-25% yesterday. Jefferies analyst Andrew Tsai said:
President Trump is providing an official stamp of validation to the class in the form of an executive order, reassuring us that the FDA/HHS/White House’s support of psychedelics is real/actionable.
Which three companies could get expedited approval this week? I asked Josh Hardman, founder of Psychedelic Alpha:
By simple deduction, one must assume that those are Resilient Pharmaceuticals’ MDMA for PTSD, Compass Pathways’ psilocybin for treatment-resistant depression, and Usona Institute’s psilocybin for major depressive disorder.
At least one of these companies previously tried to apply for a National Priority Voucher - Compass Pathways - but it was removed from the list by White House officials late last year. They did not want to be seen to be giving any special favours to psychedelic companies, perhaps out of concern about a Christian Right backlash. Now, president Trump has very publicly given his support to psychedelic companies - that’s the power of Joe Rogan.
It was already widely expected that Compass and Usona could get FDA approval this year - it’s an interesting question which will be first, as they’re both seeking approval for psilocybin and are in a race for New Chemical Entity exclusivity.
Resilient, formerly known as Lykos, applied to the FDA in 2024 for its MDMA-assisted therapy for PTSD, and was rejected - the FDA said the application was missing data on adverse events. The company has some very wealthy and powerful backers with close links to the Trump administration, including Elon Musk, his friend and business partner Antonio Gracias (who owns a stake in Resilient), and friends and business partners Steve and Genevieve Jurvetson, who donated to MAPS, the psychedelic NGO which created Resilient. The Jurvetsons were watching in the Oval Office this Saturday.
I’ve covered this field closely for four years. There have been three big moments in that time - MAPS’ Psychedelic Science conference in 2023, which was the height of euphoria; the FDA’s public AdComm hearing rejecting Lykos’ application, which was the industry’s nadir; and now this extraordinary EO. Ultimately, wealthy and powerful supporters of psychedelics, including Joe Rogan, were willing to spend political and financial capital to give the drugs they believe in a big push, and they found a president willing to do a deal.
After the paywall, I break down how this happened, explore the surreal comedy of the press conference, and give some of the different perspectives and responses to this historic moment for the field, as well as my own take.
How did this happen and what should we make of it?
