WASHINGTON — Federal health regulators announced Friday they will expedite reviews of three experimental psychedelic medications designed to treat mental health disorders, marking the latest step in the Trump administration’s push to advance these controversial treatments.
The decision follows an executive order signed by President Trump last weekend that instructed the Food and Drug Administration and other federal agencies to accelerate access and reduce barriers for psychedelic substances, which currently remain federally prohibited.
According to the FDA, priority review vouchers were granted to two pharmaceutical companies researching psilocybin — the psychoactive compound found in magic mushrooms — as a treatment for severe depression cases. A third company received expedited status for methylone, a substance similar to MDMA, targeting post-traumatic stress disorder. The agency chose not to identify the specific companies in its announcement.
While these vouchers don’t ensure final approval, they signal that federal reviewers will work to compress their evaluation process from several months down to just weeks.
This shift toward psychedelic medicine aligns with increasing enthusiasm for these consciousness-altering substances among Trump’s base, particularly military veterans and supporters of the Make America Healthy Again initiative led by Health Secretary Robert F. Kennedy Jr.
During congressional testimony last July, Kennedy stated his department’s goal to make psychedelic treatments accessible for challenging psychiatric conditions within twelve months. Several of Kennedy’s key advisors and team members advocate for these substances.
Senior health adviser Calley Means, who previously worked on Kennedy’s campaign, has written extensively about what he calls the “mind-blowing” potential of psychedelics and has disclosed plans to invest in companies developing these drugs.
The FDA’s preferential treatment of psychedelic research is expected to spark renewed criticism of its expedited review program, officially called the Commissioner’s National Priority Voucher program.
Congressional Democrats have pointed out that vouchers often go to companies with political connections to the administration, including those that have agreed to reduce medication costs.
In a related development, the FDA approved preliminary testing of a substance derived from ibogaine, a potent psychedelic extracted from an African plant, for treating alcohol addiction. Though ibogaine can trigger dangerous heart complications, it has gained popularity among combat veterans seeking relief from trauma and substance abuse.
The company behind this research, DemeRx, is headed by a Florida-based scientist who began ibogaine studies in the 1990s before federal officials withdrew public funding. DemeRx’s compound is a modified version of ibogaine that the company claims eliminates the original drug’s safety concerns.
A White House gathering on psychedelics held Saturday revealed how Trump’s political supporters influenced his administration’s priorities on this issue.
Podcaster Joe Rogan, who attended the Oval Office event, revealed he sent Trump a text message about ibogaine, which he frequently discusses on his program. According to Rogan, the president responded immediately: “Sounds great. Do you want FDA approval? Let’s do it.”
White House staff credit Rogan’s endorsement of Trump just before the November 2024 election as crucial to the president’s victory.
During his show this week, Rogan explained he discovered ibogaine through Ed Clay, a mixed martial arts coach and business owner who operates treatment retreats in Mexico.
Nearly all psychedelic substances, including LSD, psilocybin, and MDMA, fall under Schedule I classification, reserved for high-risk drugs with no recognized medical applications.
For years, pharmaceutical companies avoided these substances due to the legal complexities of researching federally banned drugs.
However, numerous smaller drug companies, many backed by Silicon Valley investors, have recently entered the competition to secure FDA approval for various psychedelics. Tech entrepreneur Peter Thiel — who has financially supported both Trump and Vice President JD Vance — has invested in AtaiBeckley, a firm researching MDMA and other psychedelic compounds.
