President Donald Trump signed an executive order on April 20 that aims to accelerate the approval of psychedelic therapies for mental health conditions. The move was welcomed by companies in the field, including Compass Pathways and Definium Therapeutics, whose shares rose sharply following the announcement.
The new policy is intended to help millions of Americans suffering from mental health conditions by providing faster access to innovative treatments. Steve Levine, chief patient officer at Compass Pathways, said, “First and foremost, this is amazing news for patients. This clearly reflects that President Trump and this administration recognize that there are millions of Americans who are suffering from mental health conditions, that are underserved, that need new, innovative options, and they recognize the potential of emerging psychedelics to meet that need.”
The order instructs the Food and Drug Administration (FDA) to issue Commissioner’s National Priority Vouchers (CNPVs) for certain psychedelic drugs. These vouchers will allow qualifying products to be reviewed in as little as one or two months instead of the usual ten-to-twelve-month timeline. FDA Commissioner Marty Makary announced three such vouchers would be issued this week. Holly Fernandez Lynch from the University of Pennsylvania raised concerns about political influence over regulatory decisions: “It’s a pretty egregious step for the White House to direct FDA with regard to specific products... The language seems pretty intense.”
Compass Pathways is expected to benefit from this initiative as it nears submission for its psilocybin-based therapy COMP360 targeting post-traumatic stress disorder (PTSD). Definium Therapeutics could also receive a voucher due to upcoming clinical trial results for its LSD-based therapy DT120.
Makary encouraged consideration of real-world evidence in drug evaluation but emphasized continued reliance on randomized trials: “There are a lot of medications in medicine where we don’t know exactly how it works... If we actually listen to those who experience the therapeutic value, we can learn as a medical field... We have to do [randomized trials] because we need to be able to say there’s good support when we recommend these therapeutics.” Both Levine and AtaiBeckley CEO Srinivas Rao stressed their commitment not just toward rapid review but also thorough scientific evaluation.
Aside from priority review vouchers, Trump’s executive order calls for expedited rescheduling of certain compounds and increased funding through federal research agencies. It also mentions expanded access under laws like Right To Try.
Ibogaine—a compound highlighted during Saturday's announcement—was noted both for its potential against opioid addiction and its safety risks such as cardiac toxicity. Deborah Mash of DemeRX stated noribogaine does not carry these same risks but acknowledged ongoing regulatory hurdles.
Some experts worry about public perception following high-profile endorsements at Saturday's event involving Joe Rogan and Robert F. Kennedy Jr., questioning whether politics might overshadow scientific rigor in future approvals.
