The Push to Approve Psychedelics for Mental Illness

In late April, the FDA issued priority review vouchers to three companies developing psychedelic treatments, part of a Trump administration executive order stating psychedelics have shown potential in clinical studies for serious mental illness. This CNBC segment connects the order to years of psilocybin and MDMA research, veteran testimony from VA treatment, and scientists' concerns that the accelerated timeline may be outpacing the evidence. It also asks why the shift is happening now, attributing the political angle to sources cited in the segment rather than presenting it as fact.

An executive order accelerates FDA review

The vouchers, issued in late April, fast-track final review under an order signed April 18th that frames expanded access as addressing a "crisis of serious mental illness," citing over 14 million American adults with a diagnosable disorder that substantially interferes with their lives. Compass Pathways, the only public voucher recipient, saw its stock rally along with other psychedelic companies. The order also reclassified marijuana, a reversal from the president's earlier drug stance, part of an uneven global picture of psychedelic drug laws.

Veterans describe their treatment

CNBC interviewed VA-treated veterans. Marie Phelan, diagnosed with complex PTSD after service including a 2003 Iraq deployment, joined a VA trial involving MDMA, describing it as an experience that "just cracked my heart wide open." Juliana Mercer, a Marine veteran who directs the advocacy group Healing Breakthrough, said her experience gave her "permission to heal," and argues the VA is proactively preparing for real world implementation, separate from the efficacy question still pending at the FDA.

What the clinical evidence shows

Two vouchered companies are developing psilocybin treatments; one studies an MDMA-like compound for PTSD. Psilocybin research has focused mainly on depression, and phase two data from Usona Institute and Compass Pathways, plus early Compass phase three results, are described as some of the strongest evidence so far, though researchers note limitations. One cited study found over 70 percent of severe PTSD participants no longer met diagnostic criteria after MDMA assisted therapy, yet the FDA rejected an MDMA application in 2024 over study design concerns. Ibogaine, also named in the order, has never had a US clinical trial on its safety or efficacy; a source says confidence in its standing was "a bit overstated," and it carries known cardiovascular risk despite smaller studies showing promise for addiction treatment. See Psylopedia's safety and harm reduction guide for context.

Political pressure and the question of timing

Some scientists worry the pace could outrun clinical data, historically a major barrier to adoption. Compass says normal review takes roughly ten months versus the order's one to two month expedited path, and standards have not changed. A researcher raises a sharper concern, that standards could be relaxed "for politically motivated reasons," while acknowledging that is unconfirmed. The segment also cites Health Secretary RFK Jr's advocacy for alternative therapies and unnamed sources speculating the administration wants to win back political support, pointing to an April CNBC approval-rating survey. Veterans pushed back, citing VA benefit cuts and unease at being treated as symbolic support.

Key takeaways

• ●The FDA granted priority review vouchers to three psychedelic drug companies under an April executive order, shortening roughly ten month review to one to two months.
• ●Compass Pathways was the only public voucher recipient; its stock, and other psychedelic companies' shares, rallied afterward.
• ●Veterans, including Marie Phelan and Juliana Mercer, described MDMA assisted VA therapy as significant for treatment resistant PTSD, though this is testimony, not clinical data.
• ●Over 70 percent of severe PTSD participants in one cited study no longer met diagnostic criteria after MDMA assisted therapy, yet the FDA rejected an MDMA application in 2024.
• ●Ibogaine, despite being named in the order, has no US clinical trial behind it and carries known cardiovascular risk.
• ●Claims about the order's political timing are attributed to unnamed sources and a survey, not fact; veterans interviewed were skeptical it alone would shift their support.