Trump Administration’s FDA Commissioner Makes Psychedelics a Top Priority

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Psychedelics and cannabis have experienced similar woes at the federal level. Both have received Schedule I classifications which places red tape on medical professionals seeking alternative treatments for their patients and expanding research that could prove the medicinal benefits of the cannabis plant or psychedelics, such as the psilocybin mushroom.

That luck may be changing for psychedelics. Recently, US Food and Drug Administration (FDA) Commissioner Marty Makary discussed in an interview with NewsNation (1,2), the FDA’s new initiative on psychedelics.

Dr. Makaray said in the interview that (1), “We have to listen to doctors who have these experiences, and this is one of our top priorities at the FDA, to listen to doctors, to listen to patients and to make sure we don't get in the way with red tape. We want to do proper independent evaluations, but we've got to do it quickly.”

During the interview (1,2), Dr. Makaray referenced that psychedelics have been used for a variety of conditions such as, traumatic brain injuries, post-traumatic stress disorder (PTSD), and severe refractory depression. Although he did not provide further information, he mentioned that these conditions have been “significantly helped” by psychedelics (2). For example, psilocybin, ibogaine, and MDMA.

“I think we need to look at how we evaluate and consider these medications. There are ongoing clinical trials that are going to read out sometime soon, and we have to take an expeditious and rapid review of that data. We can't, ‘well, our normal process is that it takes a year to give a good look at data’,” Dr. Makary commented (1). “We have got a crisis right now, and I don't think if these medicines end up showing clinical benefit in their trials, I don't think it's a silver bullet, but we owe it to people who are suffering to do everything we can as a government to get a decision on the results as soon as they're available.”

US Department of Health and Human Services (HHS) Secretary, Robert F Kennedy Jr (RFK Jr), has expressed in the past that the FDA has had an “aggressive suppression of psychedelics,” (3).

News of the FDA’s top prioritization of psychedelics has been applauded by companies in the space.

Cybin Inc., a clinical-stage neuropsychiatry company, release a press release in response to the FDA Commissioner’s comments (4).

“It is gratifying that the FDA Commissioner shares our belief in the potential therapeutic value of these innovative treatments – a long-held belief that stands at the core of Cybin’s mission,” said Doug Drysdale, Chief Executive Officer of Cybin (4). “We are doing the rigorous investigative clinical work to unlock the potential of this class of drugs to effectively treat a variety of disorders, including major depressive disorder and generalized anxiety disorder. We agree wholeheartedly that the time is now to address the mental health crisis, and we applaud Dr. Makary’s commitment to expedite the regulatory review process for product candidates in development and to get them into the hands of providers and patients as soon as possible.”

With the recent commentary from the FDA, time will soon tell on how the psychedelics space will progress forward.

References

1. NewsNation. FDA commissioner says research on Psychedelic treatment “top priority” https://www.newsnationnow.com/on-balance-with-leland-vittert/fda-commissioner-says-research-on-psychedelic-treatment-top-priority/ (accessed May 20, 2025).
2. Manalac, T. Makary backs psychedelics for Neuropsych, promises speedy review https://www.biospace.com/fda/makary-backs-psychedelics-for-neuropsych-promises-speedy-review (accessed May 20, 2025).
3. Harris Green, H. RFK Jr will cut prescription drugs and increase weed and psychedelics access https://www.theguardian.com/us-news/2024/nov/25/rfk-jr-prescription-drugs-cannabis-psychedelics (accessed May 20, 2025).
4. Cybin applauds FDA commissioner dr. Martin Makary’s call to accelerate and prioritize research on Psychedelic Therapeutics https://www.businesswire.com/news/home/20250520520032/en/Cybin-Applauds-FDA-Commissioner-Dr.-Martin-Makarys-Call-to-Accelerate-and-Prioritize-Research-on-Psychedelic-Therapeutics (accessed May 20, 2025).