FDA Could Approve Psychedelic Drug This Summer
FDA Commissioner Marty Makary told NBC News that the first psychedelic drug could be approved in the U.S. as soon as this summer, following national priority vouchers to three companies studying psilocybin and methylone.
Objective Facts
The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder. FDA Commissioner Marty Makary told NBC News that with the priority voucher program, the agency could potentially approve the first psychedelic drug by the end of summer. The vouchers shorten the FDA's review process from its standard 10 to 12 months to just one to two months. This action followed an executive order that President Donald Trump signed directing FDA Commissioner Dr. Marty Makary to prioritize psychedelic drugs with breakthrough therapy designation, and Trump's executive order calls for accelerating both research on and access to psychedelic treatments, including a $50 million investment in state governments. It's the latest move by the Trump administration signaling a shift in policy toward treatments that also give users a high.
Left-Leaning Perspective
The American Psychiatric Association, covered by CNN, said it "welcomes federal investment in research into psychedelic therapies" but emphasized that "current scientific evidence is not sufficient to support use of these therapies outside of approved research settings," with Dr. Marketa Wills, the association's CEO and medical director, stating that "rigorous study, strong patient protections, and physician-led oversight will be essential to ensure safety and effectiveness". In TIME magazine, Mason Marks, Senior Fellow at Harvard Law School's Project on Psychedelics Law and Regulation, raised concerns about the fast-track approach, saying "That is a concern. That wouldn't be good for anyone" when asked whether treatments might be rushed through approval with White House pressure, warning "It could really set back what progress has been made". The Washington Times reported that Democratic members of Congress have raised concerns that the FDA's priority voucher program is being used to favor companies politically aligned with the White House, including those that have agreed to cut drug prices. Kevin A. Sabet, Ph.D., president and CEO of the Foundation for Drug Policy Solutions, told Fox News Digital that "While we support rigorous research for treatment discovery, President Trump's executive order on ibogaine puts politics and hype ahead of science by suggesting that a dangerous, unapproved hallucinogen can somehow be a medical treatment". The left-leaning coverage notably emphasizes regulatory concerns about compressed timelines and the emphasis on anecdotal veteran testimony over rigorous clinical evidence, while downplaying the potential therapeutic benefits and the genuine unmet medical need for treatment-resistant mental health conditions.
Right-Leaning Perspective
Senator Lindsey Graham, quoted on the White House website, offered unqualified support: "Totally support President Trump's executive order that will allow alternative therapies to be approved by the FDA to treat mental health issues experienced by our veterans and others. This is a very good decision by President Trump". Representative Dan Crenshaw, also cited by the White House, declared "Countless lives could be saved by this" and provided personal testimony: "I've seen firsthand what this treatment can do. I have friends who are alive and thriving because of it". Conservative Institute covered the Right to Try angle as central to conservative values, emphasizing that "for conservatives who value limited government and individual liberty, the Right to Try angle may be the most significant piece" because the administration is saying that "veterans and other patients with severe conditions should not have to wait years for a federal agency to finish its review process before they can access treatments their doctors believe may help them". The Hill quoted Republican strategist Denise Gitsham, a former George W. Bush aide, saying the Trump administration "wants to actually deliver results for veterans and those who suffer from PTSD". Right-leaning coverage prominently features veteran testimonies and emphasizes the principle of patient choice and government deregulation. The right downplays safety concerns, instead framing the accelerated timeline as necessary to help suffering veterans, and emphasizes that rigorous science will still apply despite the faster process.
Deep Dive
On April 18, 2026, President Donald Trump signed an executive order directing the U.S. Food & Drug Administration to prioritize review of psychedelic compounds and instructing the Drug Enforcement Administration and other federal agencies to reduce restrictions that may hamper research. The FDA Commissioner's National Priority Voucher pilot program was launched last year as a way to fast-track the review process for certain drugs and biological products seeking approval. This move comes after the FDA rejected MDMA for treating PTSD in 2024, with an independent advisory committee highlighting serious concerns including poor study design, allegations of sexual misconduct during trials, and potential for health risks including heart problems. Critics of the program say it was put in place without seeking input from Congress, and could ultimately undermine trust in the FDA's regulatory process by opening the door for companies to make financial contributions to the administration in an attempt to secure such a voucher. However, experts note that while the new executive order doesn't fundamentally change the evidence on safety and efficacy the FDA would need to see, it's a symbolic act that signals the administration's unusual openness to considering scheduled substances as potential treatments, with Mason Marks noting "Psychedelics being mentioned in the Oval Office, getting such prioritized attention from a president, is pretty unprecedented". The American Psychiatric Association emphasized that "rigorous study, strong patient protections, and physician-led oversight will be essential to ensure safety and effectiveness". What remains unresolved is whether the accelerated timeline will maintain scientific rigor or will compromise it under political pressure. Several questions remain unanswered, including which federal agencies beyond the FDA and VA will implement the guidance, how quickly the $50 million will be allocated, whether the DEA will reschedule ibogaine or psilocybin if approved, and while the order directs faster review, the FDA retains its authority over approval decisions. The central tension is between expanding access to potentially life-saving treatments and ensuring that drugs approved lack adequate safety documentation.