31 October 2025
Nine Months into Trump’s Second Term, Psychedelic Reform Hangs in the Balance
By: Mattha Busby
MAPS Bulletin: Volume XXXIV
There were high hopes for psychedelic policy reform when Donald Trump returned to the White House as President in January. Nine months into his second term, with a host of advocates in senior government positions for the first time in history, it appears that the stage could be set. But with the administration taking what has been condemned as an anti-science bent on health policy while pursuing deadly war on drugs tactics in other fields, what happens next is anyone’s guess.
Just before the election in November 2024, the soon-to-be health secretary Robert F. Kennedy Jr. declared that the Food and Drug Administration’s “war on public health” was about to end and indicated that psychedelic reform was his top priority after blaming the FDA for its “aggressive suppression” of the drugs. Kennedy later told Congress, on June 24, that clinical psychedelic therapy for veterans would offer a “tremendous advantage” and that the administration was “working very hard to make sure that happens within 12 months.” He later added: “Some therapies can’t wait.”
Nor, it seems, can the increased use of illegal war on drugs tactics, like the extrajudicial use of force to kill people suspected of trafficking drugs in international waters, with fresh strikes on boats in late October bringing the death toll from the bombing campaign to 57.
Kennedy’s Health and Human Services Department (HHS) has also been roundly criticized over “anti science” reforms to vaccine policy, widespread cuts and layoffs at the Centers for Disease Prevention and Control (CDC), and the Substance Abuse and Mental Health Services Administration (SAMHSA), and huge funding squeezes of up to $2 billion to the National Institutes of Health’s research grant funding pool. There are also concerns among psychedelic reform advocates that there could be risks of betting on a horse that, to some, seems to be undermining the evidence-based scientific framework for decision-making that Resilient Pharmaceuticals, formerly known as Lykos, and others are trying to appeal to.
But if the FDA chief Marty Makary is describing the evaluation of MDMA and other psychedelics as “a top priority” and is announcing initiatives like the new National Priority Voucher system which could help accelerate approval, it’s difficult not to take notice. Under the new system, Makary is significantly cutting review times for chosen drug candidates and potentially waiving the requirement for placebo-controlled trials. Makary is said to have told Kennedy regarding psychedelics reform: “We don’t want to wait two years to get this done.”
One can only presume, therefore, that Resilient Pharmaceuticals and its new shareholders hope they will be able to negotiate with the current administration to resubmit the data without the vast expense—in the tens of millions of dollars—of a fresh trial. Politico reported that Kennedy’s support for psychedelics “revived hope among psychedelics’ advocates that the FDA decision was more hiccup than death knell.” On 16 October, the FDA greenlit under the voucher system the domestic manufacturing of ketamine, which is increasingly used as a psychedelic treatment off-label and is usually imported from India or China, by pharmaceutical manufacturer Phlow, which will become the first US-based supplier and aim to help meet the rising demand. Makary said more voucher awardees would be announced in a “couple weeks.” He added: “We’ve got to try new things, we have to innovate, we have to be creative, we have to do things differently.”
PharmaTher, a ketamine and psychedelics company, welcomed the news, saying that the FDA’s decision “point[s] to sustained momentum for ketamine” and “strengthens the rationale for pharmaceutical partners to engage in the development and commercialization of novel ketamine products for new indications.” But despite the growing excitement around psychedelic therapies, none have received FDA accelerated approval, says Melissa Lavasani, CEO of the Psychedelic Medicine Coalition, an advocacy group. “In some ways there has been amazing progress,” she says, “but ultimately if you zoom out a bit we haven’t made that much progress. There hasn’t been any kind of symbolic Executive Order. There hasn’t been very much major movement in Congress.”
But the noises have been positive. Veterans Affairs (VA) secretary, Doug Collins, told a televised cabinet meeting, in April, after Trump asked for his plans on reducing the veteran suicide rate: “We’re working with Secretary Kennedy … on the possibility of psychedelic treatment.” Collins also visited a psychedelic research centre in June in New York, which is run by psychedelic researcher Dr. Rachel Yehuda and where there is an active MDMA study taking place.
Surgeon General Casey Means in October last year suggested her use of psilocybin mushrooms helped her find a romantic partner and make “space to find love”. In a post on her White House health policy wish list, Means said that researchers have little incentive to study “generic, natural, and non-patentable drugs and therapies” and that a portion of research budgets should be devoted to alternative approaches to health. Her brother Calley Means, a health activist and entrepreneur, served as a key advisor to Kennedy during the first months of his tenure and has told of a “mind-blowing, life-changing experience” with psychedelics. (Editor’s Note [11/4/25]: The DEA has had a petition to reschedule psilocybin pending since 2022, initiated by Dr. Sunil Aggarwal of the AIMS Institute. Following an initial dismissal of the petition, and a lawsuit challenging the propriety of the dismissal, the Ninth Circuit remanded, directing DEA to handle the petition properly. In August 2025, DEA transmitted the petition to HHS for medical and scientific evaluation and a scheduling recommendation.)
Further behind the scenes, Kennedy’s HHS has hired as deputy general counsel Matt Zorn—an ardently pro-reform lawyer who previously sued the Drug Enforcement Agency—whom a psychedelic business outlet coined the administration’s “psychedelics tsar.” Meanwhile, the former chief medical officer of psychedelics research organization the Usona Institute, Mike Davis, was hired as deputy director of the FDA’s Center for Drug Evaluation and Research.
But despite the hiring of pro-psychedelics figures throughout HHS, Lavasani says, there is a brewing conflict between Kennedy’s Make America Healthy Again (MAHA) movement, which has been described as an unexpected coalition of “nutritionists, mushroom shamans, and moms,” and the more conservative Make America Great Again (MAGA) camp. “MAGA are not very pro-psychedelics, and they are much more behind the scenes in the White House,” she says. “I think a lot of folks have been riding the high of having these appointees being on the record supporting [psychedelic reform], but there’s still some barriers to overcome.” For some key anti-drug MAGA figures, the idea of psychedelic reform—even solely within a medicinal framework—“is a bridge too far,” adds Lavasani.
She believes that targeted lobbying and public education campaigns will be key to any success for reform advocates. But there are still hopes that the FDA could potentially allow Resilient Pharmaceuticals to resubmit its application without new data from a fresh Phase 3 trial. Conversations will be underway behind closed doors after the company was not drawn to announce a new trial despite an influx in funding from billionaires Anthony Gracias, a private equity fund founder and close ally of Elon Musk, having served as a top official for the Department of Government Efficiency, and Chris Hohn, a British hedge fund manager and philanthropist who has been the largest single donor of UK climate protest group Extinction Rebellion.
In October, the FDA released last summer’s letter rejecting the application for MDMA-assisted therapy as a treatment for PTSD. MAPS founder Rick Doblin claimed the letter “reveals a devastating truth — the FDA moved the goalposts,” saying the FDA asked for more information from the study investigators long after the study had commenced.
There is also optimism around increased official funding for psychedelic trials, through the VA and the Department of Defense (DoD), which in February announced almost $10 million in funding for trials to study the efficacy of MDMA-assisted therapy for veterans with PTSD. In April, a new bipartisan bill was introduced to Congress in April which would establish five “innovative therapies centers of excellence” under the VA to treat, and study, veterans who have mental and physical health conditions with psychedelic-assisted therapy. At the same time, however, the DoD started testing service members for psilocin, one of the two main psychedelic components of psilocybin mushrooms.
In May, when Texas earmarked $50 million for ibogaine research and clinical trials there was another boost for the psychedelic industry. The state’s grant structure will require recipients, expected to be commercial biopharma companies, to provide a dollar match, effectively creating a public-private structure. There are hopes this could kickstart funding for the psychedelic biopharma private sector, but there are also concerns that it is effectively a means to privatize public money. Meanwhile, legislative initiatives in other states continue apace, and Colorado’s legal psilocybin treatment regime takes shape, following in the footsteps of Oregon.
Also in October, a 5-MeO-DMT drug candidate for treatment-resistant depression developed by psychedelic pharmaceutical company atai Life Sciences and UK-based biotech company Beckley Psytech was granted breakthrough therapy designation by the FDA after promising preliminary results from a Phase 2 trial. Beckley CEO and co-founder Cosmo Feilding Mellen said that the designation “will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA.”
“I’ve seen more progress in the last several months than in the past few years,” says Simeone Schnapper, a founding partner of psychedelic fund JLS. However, at a recent meeting convened by the Reagan Udall Foundation, a non-profit which works to help the FDA innovate, and attended by Makary and two former FDA commissioners, the majority of the conversation was centered around food additives, according to Schnapper. Stem cell research and innovations around oncology are also key topics of conversation during such discussions. “Because the FDA’s mandate is so broad, psychedelics don’t necessarily get buried, but they’re never the core thing, at least in the meetings I’ve been in,” Schnapper added. Psychedelic reform, “could happen today, it could happen in a year, it could never happen.”
And so, it is almost a year on from JD Vance’s appearance on the Joe Rogan Show days before the election—in which the future vice-president appeared open to providing access to psychedelic therapy to veterans, at the same time as confessing: “I know absolutely nothing about this.” There are signals of progress but it remains to be seen whether the divided Trump Administration will make any significant progress on psychedelic reform. Until further notice, the question sits in the same liminal space as the drugs themselves.
Mattha Busby
Mattha Busby is a journalist, author and speaker specialising in health policy, drugs and psychedelics, and culture.
His work has appeared in The Guardian, VICE, Rolling Stone, WIRED, the LA Times and Esquire.
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