Psychedelics are on their way to FDA approval — are we ready?

Psychedelics are on their way to FDA approval — are we ready?

By Carol Nathan

Psychedelics are generally considered to be recreational drugs, but they have become a hot topic in medicine. Some are already being used clinically for mental health and pain disorders.

With numerous clinical trials on psychedelic drugs in progress, could FDA approval of psychedelics for medical use also be coming soon?

From investigational to validation

Various psychedelic agents have already found a place in clinical medicine, and more applications are being investigated.

Ketamine, an FDA-approved anesthetic, is being used off-label to treat specific psychiatric conditions. Cannabis is being used medically in some states where it was legalized. In states where drugs such as MDMA and psilocybin have been decriminalized, researchers are able to get approval to study these in clinical trials.

Some of these substances are considered Schedule I substances, meaning they have no official medical use. Most are listed under the Controlled Substances Act from the US Drug Enforcement Administration.

Amanda Zeglis, DO, MBA, an MDLinx psychiatry medical advisor, provided her perspective on current research into psychedelics. “At this point, psychedelics are for the most part still considered investigational, in that various groups are still conducting in-depth research on their effectiveness and tolerability,” she said. She notes that the FDA approval process can be extensive, but necessary.

“In the end, the FDA approval process works to ensure that the safety of medication options is of utmost priority.”

— Amanda Zeglis, DO, MBA

NIH psychedelic initiatives

Creation of the Psychedelic Science and Medicine Interest Group by the NIH signaled the rising importance of psychedelics as a clinical interest. The group held its first meeting in January 2023 and another one in March.

According to the NIH, this group will “create a space within the NIH for scientists to discuss basic, clinical, and translational research related to psychedelics.” Psychedelics are being researched as therapeutics for a diverse and expanding group of conditions including, but not limited to, depression, anxiety, OCD, PTSD, cluster headaches, substance use disorders, and anorexia nervosa. Additionally, psychedelics are being explored as treatment for comorbidities such as depression associated with cancer or Alzheimer’s disease.

Some of the issues explored by the NIH group at their first meeting included[2]

  • Promises and perils of psychedelic pharmacology
  • Does subjective experience mediate the therapeutic effects of psychedelics?
  • Safety and efficacy of MDMA for treatment of PTSD
  • Psilocybin and smoking cessation
  • Ketamine-assisted psychotherapy in the treatment of alcohol use disorder and other addictions
  • Ethical considerations in conducting psychedelic research

Establishment of psychedelic clinical associations

In line with the recognition of psychedelic research by the NIH is the recent establishment of medical associations dedicated to psychedelics.

These include the Psychedelic Medicine Association, the American Association of Psychedelics, the Multidisciplinary Association for Psychedelic Studies, and several others.

An organization focusing on ketamine is the American Society of Ketamine Physicians, Psychotherapists, and Practitioners, a nonprofit dedicated to the safe clinical use of ketamine for mental health disorders and pain conditions. According to the standards of practice of the organization, “over the past decade, doctors and therapists with various degrees and backgrounds have discovered and crafted the synergy of combining ketamine and psychotherapy to treat PTSD, anxiety disorders and other maladies.”

According to Jill Gabay, CRNA, founder of Ketamine Wellness Infusions in Pennsylvania, “This is the tip of the iceberg; psychedelics have already been shown to be therapeutic. The dosing and routes of administration may be tweaked, but the substances are already proving their worth.”

“Ketamine,” she went on to say, “is a safe and effective drug.”

“It should be approved for the treatment of mood disorders so that it would be covered by insurance and readily available to anyone who needs this treatment.”

— Jill Gabay, CRNA; Ketamine Wellness Infusions

FDA approval status

A commentary in the American Journal of Medicine addresses the daunting efforts required in bringing psychedelic drugs to approval.[3] The author states that “research into psychedelic drugs is exploding, with the encouragement of the US Food and Drug Administration (FDA),” and he anticipates that recent successes with clinical trials will soon find some long-banned drugs authorized as treatments for debilitating illnesses.

Yet because of these drugs’ history, FDA approval would be “just one important step in a complex process to transform these compounds into therapies.”

As the author further notes: “Incorporating psychedelic drugs into clinical practice will require peeling back multiple layers of legal prohibition, clarifying prescribing guidelines, and developing treatment models that work for drug makers, physicians, and payers.”

Lingering hesitation?

Dr. Zeglis was asked if she thought doctors and patients would be open to using psychedelics as part of the treatment plan once they received FDA approval.

Her response was that, “as with any new medication option, there is often a period of adjustment as providers become aware of the new agents, find an understanding of their ranges for use, and then eventually gain a level of comfort in prescribing them when the circumstances align. As providers, we are always looking toward new research and opportunities to aid our patients.”

Gabay sees a two-fold aspect to the lingering hesitation in prescribing these drugs. “First, there is a need for education.” she said. “Many prescribers I’ve spoken to still do not even know that ketamine is available, and although it is off-label (for these uses), it is not illegal. Second, the medical community has a certain responsibility to ascertain that its providers are using these substances with integrity. There need to be standards and protocols in place to minimize the risk of misuse or profit-driven use.”

Dr. Zeglis concurs, and adds that “there are often lingering hesitations with any new strides in disease management.

“With psychedelics in particular, there is an underlying stigma that exists in many providers due to the history of recreational psychedelic use.”

— Amanda Zeglis, DO, MBA

As new research is unveiled, there is a possibility that these hesitations will at least ease, she believes, but for now, “further information is needed to ensure psychedelics hold a long-standing place in psychiatric management.”

What this means for you

Although these new psychedelic research initiatives are yielding promising results, there are many challenges related to incorporating them into clinical practice and gaining patient acceptance. It is important that the research and FDA approval process move slowly and carefully, given the significant risks and hurdles that psychedelics as medications present. It is therefore important that HCPs stay informed about the new developments, both for clinical practice and patient information purposes



Carol Nathan

Carol Nathan has more than 15 years of medical writing and editing experience (digital and print), in senior level staff positions with medical publishers and pharmaceutical agencies (she is now a freelance medical writer). Most recently, she was CEO of, a medical search site for healthcare professionals.

Previously, she was vice president of Custom Programs at Frontline Medical Communications, where she oversaw a team of medical writers creating pharmaceutical-sponsored content for 30 medical journals, including journal supplements, websites, medical quizzes, slide decks, clinical trial summaries, HCP roundtables, videos, and more.

Earlier in her career, Carol was Editor of The Female Patient, a women’s health medical journal for physicians, and on the editorial staff of Patient Care magazine, a primary care medical journal for physicians. She also has worked at Edelman and Ogilvy pharmaceutical advertising agencies.

Carol has a dual BS major in Journalism and Business from Syracuse University.

DISCLOSURES: Carol has a diverse group of clients for which she provides editorial, promotional, and CME content, including medical journal publishers, medical communications websites for HCPs, and pharmaceutical companies.

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