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Backed by Joe Rogan, President Trump signed an executive order instructing the FDA to issue priority vouchers “to appropriate psychedelic drugs.” \n Ever since psychedelic medicine in the U.S. was stymied by government action, the field has been steadily clawing its way back toward legitimacy. Swiss chemist Albert Hoffman, Ph.D., discovered LSD’s hallucinogenic effects first-hand in 1943, and further research raced ahead until President Richard Nixon signed the Controlled Substances Act in 1970 and severely restricted access to many psychedelics.The attitude to using psychedelics like the magic mushroom extract psilocybin as therapeutics has gradually softened over the years, culminating in the second Trump administration ordering the FDA last month to fast-track reviews of psychedelic drug candidates for mental health conditions. In response, the agency granted priority review vouchers for three biotechs working in this field. So has the time finally come for psychedelics to cross the regulatory finish line and become legitimate medicines?“Clearly, this level of broad political endorsement for the field is helpful, and we\'re grateful for that,” Kabir Nath, CEO of British psychedelic biotech Compass Pathways, told Fierce in an interview. Compass is a recipient of the latest batch of Commissioner’s National Priority Vouchers (CNPVs), alongside Transcend Therapeutics and the nonprofit Usona Institute.Compass and Usona’s vouchers are for psilocybin-assisted therapy to treat depression, while Transcend’s is for a non-hallucinogenic form of methylone for post-traumatic stress disorder (PTSD).Otsuka Pharmaceutical, which has a $1.2 billion acquisition of Transcend in the works, agreed with Nath’s sentiment in a statement to Fierce.“What matters most is the attention FDA is giving these important therapies to support rigorous, science-based evaluation, while enabling innovation to move forward with urgency and integrity,” an Otsuka spokesperson said. Even psychedelic biotechs that haven\'t received vouchers still appreciate the support. Helus Pharma, which is also developing drugs based on psilocybin, said President Donald Trump’s executive order “signals a clear shift in the federal government’s posture toward the potential of psychedelic medicines.”“That creates real momentum for companies like ours,” a Helus spokesperson told Fierce in a statement. “We expect this policy environment to meaningfully support our ability to drive interest in our clinical programs and advance toward regulatory submissions.”But political support from the Trump administration is not the same as political support from past administrations. And the way this latest psychedelic push apparently kicked off—with a text from podcaster Joe Rogan—is a serious departure from how health policy has been decided previously.Trump’s response to Rogan’s text about the psychedelic ibogaine, according to the podcaster himself, was: “Sounds great. Do you want FDA approval? Let’s do it.”Not long after, Trump signed an executive order in the Oval Office, with Rogan beaming behind him, instructing the FDA to issue priority vouchers “to appropriate psychedelic drugs.” The order also directs the Advanced Research Projects Agency for Health (ARPA-H) to provide $50 million in support of state-led efforts to study psychedelic drugs, likely intended for Texas’ planned trials of ibogaine, a psychedelic compound derived from an African shrub. Rogan lives in Texas and recently discussed ibogaine in a podcast conversation with Health and Human Services Secretary Robert F. Kennedy Jr.“That\'s completely absurd and really terrifying,” Holly Fernandez Lynch, a medical ethicist and regulatory expert at the University of Pennsylvania School of Medicine, told Fierce. “That is not how this gold-standard regulatory agency is supposed to work.”Democrats on Capitol Hill agreed. During a hearing with Kennedy, Rep. Jacob Auchincloss (D-Mass.) repeatedly pushed the secretary on the psychedelic vouchers and Rogan’s influence.“We are literally seeing politics put over science,” Auchincloss said. Due to political influence from the White House, the congressman argued, the FDA “issued three priority vouchers from this illegal, unauthorized program.”Auchincloss and others in Congress have been critical of the CNPV program since its inception, saying the scheme could “enable corruption.” FDA veteran Richard Pazdur, M.D., who served as the agency’s top drug regulator before departing last December, has also railed against the voucher program and warned of political influence “that has seeped into the regulatory decision-making.”Fernandez Lynch claims there have been “political favors happening in terms of who gets a voucher,” but so far, the FDA’s review of drug candidates given vouchers does not appear to be compromised. Notably, there has been a rejection for a company given a CNPV—Disc Medicine’s bitopertin for a rare genetic disease that causes sun sensitivity was turned down in February.“There does still seem to be some rigorous review,” Fernandez Lynch said. But psychedelics are so new for the FDA, she added, that trying to review them quickly “makes me a bit nervous.” The goal of the CNPV program is to conduct drug reviews in just one to two months.Former FDA Commissioner Scott Gottlieb, M.D., who led the agency from 2017 to 2019 during Trump\'s first term, celebrated the president\'s executive order in a Washington Post op-ed.“His policy pairs faster drug development with continued FDA oversight,” Gottlieb wrote. “As the MAHA movement pushes for relaxed access to other substances, the president has provided a public health model worth following.”There are signs that the FDA won’t just rubber-stamp psychedelics. The first traditional psychedelic submitted for approval, an MDMA compound from Lykos Therapeutics meant to accompany therapy for PTSD, was rejected by the agency in August 2024. But that rejection followed an advisory committee meeting that overwhelmingly sided against approval, and the FDA under Trump has largely deemed such committees irrelevant.Johnson & Johnson\'s nasal spray Spravato is a version of ketamine that was approved in 2019 for major depressive disorder. Because ketamine\'s primary effect is anesthetic, it is not typically considered a traditional psychedelic, though it does produce dissociative effects and is used recreationally. Andrew Nixon, the deputy assistant secretary for media relations at HHS, told Fierce that the three psychedelic voucher recipients announced last month were chosen by career scientists at the FDA.“President Trump’s executive order reflects a simple reality that too many Americans, especially veterans, are still struggling with serious mental illness while existing treatments fall short,” Nixon said. “The Trump administration is embracing science-driven research and giving patients a clearer path to innovative therapies through the FDA’s regulatory pathways.”Between 6% and 55% of patients with depression are estimated to have treatment-resistant disease, depending on the study. PTSD affects about 6% of U.S. adults at some point in their life, according to the National Center for PTSD, with veterans facing a slightly higher prevalence of 7%.Nixon did not respond to detailed questions from Fierce about the influence that the White House and Rogan have on the FDA’s regulatory decisions, the intended recipients of the $50 million ARPA-H funding, or the specific process by which Compass, Usona and Transcend were chosen as voucher recipients.An ARPA-H spokesperson confirmed to Fierce that the $50 million in funding is part of the broader, $139 million behavioral health initiative called Evidence-Based Validation and Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT). The first award recipients from that program were announced April 21.“EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness,” the spokesperson said. Guiding the way The closest of the three new CNPV recipients to submission for approval is Compass, with the biotech’s COMP360 for treatment-resistant depression also recently okayed for a rolling review process. COMP360 is a synthetic form of psilocybin, given alongside therapy, that scored a phase 3 win earlier this year.“We will be launch-ready by the end of the year,” Compass CEO Nath told Fierce. The company plans to sit down with the FDA in the coming weeks, he said, to discuss further ways to speed up COMP360’s filing. Once the filing is complete later in the year, Nath expects the CNPV to deliver “an earlier approval than we were otherwise planning for.”Compass’ voucher follows reports earlier this year that the company had been denied access to the CNPV program by the White House. According to Stat News, when FDA Commissioner Marty Makary, M.D., presented a list of potential voucher recipients to the White House last October, Trump officials struck Compass off the list.Compass executives told investors in July 2025 that the company had applied for a voucher.Despite this, Nath told Fierce that the biotech was already in a good position with the FDA before finally garnering a voucher. COMP360 has a breakthrough therapy designation, he pointed out, and conversations about the potential for a rolling review were happening around the same time as the reported White House rebuff.“We were already in a really robust position, and that was based on the fact that we\'ve done these two large phase 3 trials, the largest ever psychedelic trials,” Nath said.The FDA did not respond to questions from Fierce about Compass’ past voucher rejection.Should Compass succeed in snagging approval for COMP360, it will be a milestone moment not just for the company, but for the entire field of psychedelic medicine.“We recognize that we\'re carrying the hopes and aspirations, not just of lots of patients, but to some degree of the field,” Nath said. “We\'re very confident that we first can get a regulatory approval, then launch successfully.”While psychedelics carry stigma due to their potential for recreational use and abuse, and the FDA has limited experience with them, there is no meaningful difference between these drugs and other therapeutics, Fernandez Lynch said.“It\'s kind of bizarre to treat psychedelic medicines as though they are different from any other medicines,” she told Fierce. “If you\'re making a medical claim about them, there\'s no reason why they shouldn\'t be treated just like any other drug.”James Waldron contributed reporting.