FDA to expedite psilocybin reviews as White House directs faster action
Miami University researchers are developing a synthetic manufacturing method to lower costs while the agency issues priority vouchers to two pharmaceutical firms.
By Bianca Herrera ·
The U.S. Food and Drug Administration is accelerating the review process for psilocybin, the active compound in magic mushrooms, following a directive from the White House to treat serious mental illness with urgency. FDA Commissioner Marty Makary stated that these medications hold potential for addressing treatment-resistant depression and other substance abuse conditions. The agency is issuing national priority vouchers to three companies currently studying psilocybin for treatment-resistant depression and major depressive disorders.
Psilocybin remains classified as a Schedule 1 drug in the United States, a status that restricts its availability outside of clinical trials and specific state programs. Several states have already moved toward legalization, with Oregon and Colorado operating fully supervised programs. South Dakota passed legislation in March 2026, and Minnesota has ordered a feasibility study due in January 2027. Canada, the Netherlands, and the Czech Republic have also adopted legal frameworks for therapeutic use under professional supervision.
Researchers at Miami University in Oxford, Ohio, are working to reduce the production costs of the compound. Associate Professor Andrew Jones leads a team that uses bacterial DNA to synthesize psilocybin in a lab setting. This biological method allows for production overnight, a significant reduction from the weeks or months required for traditional mushroom cultivation. Jones has licensed this technology to Eywa Biotech, a company based in Uruguay that is working toward production in Australia.
Clinical data supports the push for wider access. A study published in July 2026 by Ohio State University found that 75 percent of twelve veterans with treatment-resistant post-traumatic stress no longer met diagnostic criteria after a one-month follow-up. The study marked the first U.S. clinical trial of psilocybin-assisted therapy for veterans who did not respond to traditional medication. The Veterans Administration has since announced a new trial to evaluate the safety and effectiveness of psilocybin for major depression.
Makary emphasized that development must be grounded in sound science and rigorous clinical evidence. She noted the importance of evaluating these therapies with urgency for veterans and other Americans suffering from these conditions. The White House executive order directs the FDA to speed up action, aiming to bridge the gap between the U.S. and other nations that have already approved the drug for medical use.
The next steps involve completing Phase 3 clinical trials to demonstrate safety and efficacy. Following a positive FDA review, the Drug Enforcement Administration may reschedule psilocybin from Schedule 1 to a lower category. Jones and his team are also developing non-hallucinogenic versions of the compound, aiming for a treatment that works through similar brain mechanisms without the prolonged sensory experience.
Miami University student scientists, including Sophia Pyritz and Siena Madsen, are assisting in the DNA manipulation process. Madsen focused on ensuring the treatment remains accessible to patients who need it, citing social justice as a primary motivation. The university's goal is to create a product that is faster to produce, more scalable, and environmentally sustainable compared to growing mushrooms.
