The Food and Drug Administration (FDA) announced on Friday that it will provide ultra-fast review to three psychedelic drugs being developed for hard-to-treat mental health conditions, including depression. This move marks the latest indication of the Trump administration's commitment to advancing experimental treatment approaches for psychiatric disorders.
Executive Order Spurs FDA Action
President Donald Trump signed an executive order last weekend, directing the FDA and other federal agencies to expedite access and loosen restrictions on psychedelics, a class of hallucinogenic drugs that remain illegal under federal law. The FDA responded by awarding priority review vouchers to two companies studying psilocybin, the active ingredient in magic mushrooms, for treatment-resistant forms of depression. A third company received a voucher for methylone, a drug related to MDMA, for post-traumatic stress disorder (PTSD). The FDA did not disclose the names of the companies in its press release.
These vouchers do not guarantee approval but indicate that regulators will aim to shorten their review timeline from several months to just weeks.
Growing Support for Psychedelics
The recent actions on psychedelics reflect increasing popular support for these mind-altering substances among Trump's supporters, particularly combat veterans and followers of the Make America Healthy Again movement, which is spearheaded by Health Secretary Robert F. Kennedy Jr. Last July, Kennedy told members of Congress that his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year. Several of Kennedy's top allies and staffers are known proponents of the drugs.
Calley Means, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the "mind-blowing" power of psychedelics and his plans to invest in companies developing these substances.
Scrutiny of FDA's Priority Voucher Program
The FDA's special treatment for psychedelics is likely to renew scrutiny of its program for speeding up drug reviews, known as the Commissioner's National Priority Voucher program. Democratic members of Congress have noted that vouchers have been awarded to companies that are politically favored by the White House, including those that have agreed to cut prices on their medications.
In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic derived from an African shrub, for individuals with alcohol use disorder. Ibogaine is known to sometimes cause dangerous heart rhythms but has been embraced by combat veterans as a way to treat trauma and addiction. The drugmaker, DemeRx, is led by a Florida-based researcher who first began studying ibogaine in the 1990s, before federal health officials withdrew public funding for the work. DemeRx's drug is a metabolite of ibogaine, and the company claims it does not carry the same risks as the original substance.
Political Influence on Psychedelic Agenda
Saturday's White House event on psychedelics suggested that Trump's political allies played a role in pushing these drugs to the top of his agenda. Podcaster Joe Rogan, who appeared at the Oval Office event, said he texted Trump about the psychedelic ibogaine, which he has repeatedly discussed on his show. According to Rogan, the president quickly responded: "Sounds great. Do you want FDA approval? Let's do it."
Rogan's endorsement of Trump days before the November 2024 election was seen by White House aides as a key factor in his electoral victory. On his show earlier this week, Rogan said he learned about ibogaine from his friend Ed Clay, a mixed martial arts trainer and entrepreneur who runs retreats in Mexico that utilize the drug.
Legal Status and Industry Interest
Virtually all psychedelics, including LSD, psilocybin, and MDMA, are classified as Schedule I substances, a category for high-risk drugs that have no medically accepted use. For decades, drugmakers steered clear of these substances due to the difficulties of studying drugs that are illegal under federal law. However, dozens of small drugmakers, many fueled by Silicon Valley investors, have recently entered the race to win FDA approval for various psychedelics. For example, tech billionaire Peter Thiel, who has made political donations to both Trump and Vice President JD Vance, has invested in AtaiBeckley, a company studying MDMA and other psychedelic compounds.
