Psychedelic drug treatments are gaining momentum at the federal level, prompting the Food and Drug Administration to solicit public input on the potential supervised therapeutic use of psychedelic drugs.
The FDA is taking a step toward possibly greenlighting the future use of the drugs psilocybin, a psychedelic compound found in some mushrooms, and methylone, structurally similar to the synthetic psychoactive drug MDMA.
“There has been growing interest and active research on the therapeutic potential of psychedelic drugs, in particular for treatment of serious mental health conditions,” Marta Sokolowska, deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research, said at a hearing Monday to gather input from experts.
University researchers and advocates for psychedelic treatment delved into questions about patient safety, standardizing treatments and provider training and credentialing.
Dane Stevens, CEO of Optimi Health, told The Washington Times that there is a three-pronged approach to make psychedelic treatments more accessible: licensing, standardization and transparency.
As the head of a fully licensed commercial-stage manufacturer of pharmaceutical-grade psychedelics for prescription use, he said his goal is to show the FDA that psychedelic drug treatments can be done safely.
Psychedelic-assisted treatment offers rapid relief for treatment-resistant mental health conditions, such as using psilocybin and MDMA to treat major depression and severe PTSD, but it carries risks such as psychological distress and requires strict medical supervision.
Certain studies using psilocybin for treatment-resistant depression and major depressive disorder, as well as methylone for post-traumatic stress disorder, have been given the go-ahead by the FDA.
But treatments in the U.S. face heavy bureaucratic red tape because federal laws classify psilocybin, MDMA and other hallucinogens as Schedule I drugs that have no accepted medical use. That makes medical research slow and difficult.
The effort to lower these barriers is now underway.
President Trump in April ordered an acceleration of federal research, fast-tracked FDA reviews and expanded patient access to psychedelic treatments.
Now, thanks to this whole-of-government approach, people are aware that psychedelic therapy is “much closer to home,” Mr. Stevens said.
Federal regulators can carve a pathway for eligible patients to access psychedelic drugs, if they so choose, he said.
“We would all love to see something sooner rather than later and clarity, especially as a manufacturer and someone interested in moving these medicines along,” he added.
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