Who's in the Room and Who Decides? Open Questions Following the FDA Hearing on Psychedelics
A guest column by Dr. Alaina Jaster, Produced in Partnership with Psychedelic Brain Science
By PSA Media Team
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Who’s in the Room and Who Decides?
Open Questions Following the FDA Hearing on Psychedelics
By Dr. Alaina M. Jaster
Produced in partnership with Psychedelic Brain Science
Following the completion of one of the largest regulatory events in psychedelic history, all I could think was that the Food and Drug Administration (FDA) really took the word “hearing” literally.
The FDA’s public hearing on the “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” featured listening panels made up of members of the FDA and other regulatory or collaborative organizations such the Office of Veterans Affairs, SAMHSA, NIDA and more. None of these administrators asked any questions or spoke beyond their introductions and closing statements.
The true stars of the show were the speakers, in a style more reflective of a townhall than a hearing, 80 public commenters were selected from over 200 submissions from various members of the public, stakeholders, researchers and patient advocacy groups. There were over 1,800 registered attendees in person and online. Also notably in attendance, was Dr. Mike Davis, the new Director of Center for Drug Evaluation and Research who previously served as Chief Medical Officer at Usona Institute.
This public hearing had two sessions with four topic areas: i) provider training and credentialing, ii) patient safety, iii) access and, iv) data collection and standardization. Speakers were selected based on their submissions that fit into these categories.
This hearing has been long awaited and represents a milestone in the FDA’s own preparation for the imminent approval of psychedelic compounds as medicines.
The timeline leading up to this moment:
June 2023: Original FDA public comment period opens for guidelines on “Psychedelic Drugs: Considerations for Clinical Investigations”
February 2024: FDA accepts a new drug application (NDA) for MDMA-assisted psychotherapy for treatment of post traumatic stress disorder (PTSD) by Lykos (now Resilient Pharmaceuticals).
August 2024: FDA votes to reject the NDA for MDMA-assisted psychotherapy.
May 2025: The Psychedelic Medicine Coalition hosts a Federal Summit on Psychedelic Medicine at the National Press Club. Lawmakers introduced the Innovative Therapies Centers of Excellence Act (H.R. 2623). This was the first major federal bill aimed at creating infrastructure and funding to establish dedicated psychedelic treatment hubs directly within the Department of Veterans Affairs (VA).
June 2025: Otsuka closes a $1 billion+ acquisition of Transcend Therapeutics
August 2025: AbbVie acquires Gilgamesh Pharmaceuticals for $1.2 billion in August
April 2026: Executive Order 14401 ("Accelerating Medical Treatments for Serious Mental Illness") directs the FDA to use "Commissioner's National Priority Vouchers," which drastically compresses drug review timelines from 10–12 months down to 1–2 months for qualifying treatments. The order allocates $50 million to match state-level psychedelic research and orders the FDA and DEA to open Right to Try pathways so terminally ill patients or severe trauma victims can legally access investigational psychedelics before full approval.
April 26, 2026: The FDA immediately issued these vouchers to developers studying psilocybin (for treatment-resistant and major depression) and methylone (for PTSD).
July 2026: HHS and the Department of Veterans Affairs (VA) formally announces coordinated actions and launches the ASCENT-IBO initiative. Under this, ARPA-H issued a Special Notice inviting researchers and commercial entities to compete for funding to advance early-stage (Phase 1 and 2) clinical trials of ibogaine for Opioid Use Disorder.
July 13, 2026: FDA announces public hearing on Considerations for Potential Future Therapeutic Use of Psychedelic Drugs while simultaneously publishing their guidelines.
August 2026: Resilient Pharmaceuticals resubmits NDA to FDA.
September 2026: The Considerations for Potential Future Therapeutic Use of Psychedelic Drugs public hearing takes place.
Setting the Stage: The FDA Clinical Trial Guidelines
Prior to this event, the FDA published their final* guidelines for clinical investigations. This guidance covers classic psychedelics (5-HT2A receptor agonists like psilocybin and LSD) and entactogens like MDMA, developed under an IND.
*The finality of this document is explicitly non-binding and subject to change.
This document covers various topics from manufacturing to nonclinical and clinical assessments of pharmacology and abuse potential. Some of the guidelines aim to fit psychedelics into the existing requirements that the FDA holds for other substances. For example, standard CGMP requirements apply at every phase and botanically-derived products (plant/fungal material) can qualify under FDA's existing Botanical Drug Development framework.
For preclinical studies, the guidelines state if a psychedelic already has substantial human-use history and no serious safety signals, FDA may allow trials to start without full standard animal toxicology. However, sponsors must specifically test for 5-HT2B receptor activity, which is tied to cardiac side effects such as valvulopathy. Interestingly, as the compound progresses, a full human abuse potential study may be skippable if subjective effects and epidemiological data are already well-characterized.
In terms of abuse potential, the FDA still defines expected psychoactive effects such as euphoria, hallucinations, cognitive shifts as effects that contribute to abuse liability and therefore these must be recorded as adverse events, regardless of whether the subject experienced them as positive. This is a large point of contention within the field.
Clinical guidance related to inclusion criteria and trial design discusses various factors including clinical pharmacology, expectancy and safety considerations. In terms of pharmacology, the guidance flags specific drug-interaction risks with SSRIs/SNRIs/MAOIs, tricyclics, lithium that should be assessed before participating to ensure no elevated risks.
One of the most difficult problems to solve in psychedelic trials is functional unblinding. Because the drug effects are so perceptually profound, the patients, therapists, and raters can usually tell who received the active drug which undermines placebo-controlled design. FDA's proposed mitigations included: blinded central raters, blinding questionnaires, expectancy questionnaires, alternative "active" comparators instead of inert placebo, and complementary trial designs. Other design recommendations include factorial designs to separate drug effects from therapy effects.
The guidelines around safety considerations and who is in the room are something that is also widely up for debate in the field. The FDA recommends two monitors per session: one lead monitor who is independently licensed with at least a graduate-level psychotherapy training and an assistant monitor with a nursing or bachelors degree and 1+ year clinical mental health experience. They note that if the lead monitor is not a physician, a licensed on-call physician must be able to reach the site within 15 minutes. They also recommend the in-session monitor does not serve as the post-session therapist, to reduce bias.
Direct Connections to the Hearing
The major questions raised in the hearing seemed to be:
- Who is the provider?
- How will providers be accredited?
- Will the FDA adopt a new criterion for adverse event reporting in psychedelics?
- How will data be collected and standardized to inform decisions on REMS easily?
Who is the provider?
The final guidance acknowledges that the contribution of psychotherapy to efficacy has not been fully characterized, although there is some evidence that both are contributing to the positive outcomes of psychedelics. The guidance distinguishes psychological support, which is directed at safety, from psychotherapy, which is a useful treatment itself. The terminology not only becomes confusing, but it becomes problematic when the field is trying to determine who is allowed to practice and how these compounds will be labeled for safety monitoring.
“Credentialing standards should not be finalized until the provider's role is defined, and that role is not yet defined,” said Dr. Peter Hendricks, Professor at the University of Alabama Birmingham and Scientific Advisor to ApolloPACT. “What we do know is that support models directed at safety rather than treatment have produced safe and durable therapeutic outcomes. If a product's evidence shows that safety-directed support is sufficient, what patients need in a session monitor is someone competent to manage acute drug effects, recognize a medical or psychiatric emergency, and hold appropriate boundaries with the person in a vulnerable state.”
Dr. Hendricks goes on to describe how psychotherapy licensure and credentialing are separate solutions, and a “framework that requires a psychotherapy license for every role would fall hardest on the people least able to find care elsewhere.”
Similarly, many others pointed out a blanket system for credentialing may be difficult across regions specifically in rural and frontier states like Nevada, Idaho, Montana, Wyoming and Utah.
“Nearly 87% of Nevadans live in a federally designated mental health professional shortage area, including every resident of our rural and frontier counties,” said John Dalton from the Nevada Coalition for Psychedelic Medicine. “Nevada has roughly nine psychiatrists per 100,000 residents. By contrast, it has more than 120 licensed clinical social workers, marriage and family therapists, and clinical professional counselors per 100,000. That workforce is already delivering mental health care.”
Several nurses highlighted that nurses can help solve this provider problem as many of them are already trained and deployable in this context. Furthermore, nurse practitioners in some states have prescribing and drug administration authority similar to physicians, allowing some flexibility in the physician rule.
Credentialing Preparation and Integration
Almost every individual who spoke on credentialing and provider training brought up the importance of covering the entire episode of care including preparation, anticipation, facilitation, and integration. Many speakers had their own training models or programs that they thought the FDA could utilize when building out their requirements.
Jeremy Rudy, Chief Executive Officer of Sabba Collective, offered a direct solution to this problem through his AI-powered simulation training platform, Praxis. He described how this type of technology can be used to rehearse the riskiest moments, assess these trainings against clear criteria, and create a record of the clinician and site’s competencies.
“Competence can be assessed and documented with auditable evidence,” said Rudy. “Praxis, our simulation based training and assessment platform draws on precedent from nursing and surgery where practice on standardized patients comes before real people.”
Patient safety is not just about accreditation, it also includes consent and the professional relationship between patient and provider. While many argued that having the same provider is an important part of the preparation, experience and integration process, one public commenter mentioned how having a separate in-session monitor and post-session therapist might actually function as a safeguard against therapist malpractice and sexual misconduct that has been reported in some clinical trials. The argument suggests that having different points of care with different individuals may offer up extra opportunities to report. On the other-side, the argument for continuity of care with the same individuals would help build up rapport between the study lead or therapist and the patient promoting better therapeutic outcomes.
Additionally, the therapeutic window or induction of neuroplasticity was discussed by multiple speakers. The major hypothesis surrounding psychedelic assisted therapy is that a period of neuroplasticity opens following the experience due to reorganization of the brain, which puts the individual in a heightened state where they can implement adaptive lifestyle changes. Many presenters argued that this is a central tenant of integration and should not be ignored when thinking about how providers are interacting with patients after the session.
“While we know there is this tremendous window of neuroplasticity post-psychedelic use, we also need guidance and guardrails around where that neuroplasticity goes,” said Dr. Jane Kaplan, psychiatrist and founder of East West Global Healing. “How do people best re-sort their thoughts, feelings, and somatic experiences post-psychedelics?”
Data Collection and REMS
Probably the largest complaint comments had was focused around the language requiring all central nervous effects as adverse events. The lack of reporting of adverse events deemed as “positive” by the participant and sponsor was cited as part of the decision to reject the Lykos (now Resilient Pharmaceuticals) application for MDMA-assisted therapy in 2024.
Dr. Alia Lillian Stein, who previously served as a clinic lead for the Phase 3 MDMA trials but is now a regulated psilocybin provider for Odyssey, told a story about one of her patients' experience with psilocybin. Since her dosing session, the patient had increased meditation, needed less external validation and noticed less rumination. However, the current FDA guidelines would require this “increased well-being” as an adverse event.
“Where’s the line? Should changes in ordinary love, joy, empathy, and compassion really be considered adverse events?” Dr. Stein said. “Currently, some investigators report these events as AEs and others do not. As a result, trial data reflects each team’s own guess at what a positive adverse event means, not the drug’s true safety or abuse potential.”
Her solution is to employ something similar to oncology’s common terminology criteria for adverse events (CTCAE). This questionnaire sets terminology criteria for adverse events, which defines terms and criteria for what counts as an adverse event and at what severity. This work is ongoing at University of California Berkeley and San Francisco.
Opposite of this issue is the problem of monitoring risk for more serious physiological adverse events. Psychedelics, while an overall classification of perception-changing substances, have individual differences that warrant substance specific risk evaluation and mitigation strategy (REMS). For example, the valvulopathy risk through 5-HT2B receptor activation is an identified risk for some polypharmacological psychedelics. Ibogaine carries a much greater risk of cardiac adverse cardiac events including QTc prolongation and ventricular arrhythmia, however no validated prediction model yet exists.
“No validated prediction model exists [for ibogaine cardiotoxicity],” said Odette Hauka, founder and principal of independent regulatory affairs consultancy company Odette Alina LLC. “That is a data standardization problem. It needs perspective, pooled data, adverse events, pre-specified, defined, identified, reported, acute and long-term, and common data elements for drug dose indication, setting patient characteristics, metabolizer status, and time-matched ECG. The notice contemplates coordinated registry networks. Without common data elements, a registry produces volume, not evidence.”
Many other speakers echoed similar concerns with data collection and stratified REMS specific to each substance's unique pharmacology and indication. One way to solve the problem would be to take real-world evidence from the few states and countries that have begun giving legal and regulated psychedelic therapy and apply what works, but get rid of what doesn’t.
While the focus of this hearing was largely focused on psychedelics for neuropsychiatric indications, it’s important to recognize that psychedelics have shown promising results for other neurological indications and chronic pain. Outside of neuropsychiatric indications, there is a large body of evidence for psychedelic efficacy in migraine disorders such as cluster headaches. However, the doses of psychedelics that treat these issues are usually sub-perceptual and therefore would not need the same oversight as doses producing large perceptual changes.
“I hope the FDA will consider uncoupling psychedelics from the restrictive psychedelic-assisted therapy container,” said Aileen Brewer, a nonprofit consultant and member of Marylanders for Beneficial Psychedelics. “Guidance must be broad enough to allow different ways that psychedelics can and will be used to treat chronic pain conditions and other conditions…Not all patients need psychedelics to be administered in a clinic with mental health professionals.
Interestingly, multiple representatives from Australia were present at the FDA hearing. In 2023, the Australian Therapeutic Goods Association (TGA), allowed psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment resistant depression. Their treatment centers have large regulatory oversight including 12 month follow-up for every patient, but the results have been durable. Greg Hutchinson, chairman and investor of Emyria Limited, cautioned that standardization and clinical governance is taxing but necessary to ensure results.
“Managing these patients has helped shape our own care model and screening programs,” said Hutchinson. “Learning came from training our own clinicians, supervising them, and collecting data on every patient from day one. That data has given rise to treatment improvement over time. Trials set the starting point but frontline providers armed with data advance the field.”
Honorable Mentions
There were so many other points and topics that ebb and flow through these four core themes, all of which are equally important.
There was a great emphasis put on preparing professionals to “steward experiences that profoundly change how people understand themselves, their relationships and lives” but actual indigenous stewardship of psychedelic medicines was largely undiscussed. While the FDA holds regulatory jurisdiction over products manufactured or sold on designated reservations, the reality of tribal sovereignty and federal regulations is complex and there is a large push for the FDA to recognize indigenous use, stewardship and protection of psychedelic medicines like mescaline, peyote and ayahuasca. However, there was no tribal representation in the speakers chosen at the hearing.
Laurel Kilgore, an attorney with the Psychedelic Bar Association, argued for ethical stewardship within the psychedelic ecosystem. Her arguments were largely focused on access-limiting REMS and employing other avenues to accessing psychedelic medicines including through Right to Try frameworks, religious use and indigenous stewardship.
The second honorable mention was considerations of set and setting to the FDA guidelines. There were several comments that identified the powerful influences that a setting can have on psychedelic outcomes including the impacts of group, individual, guided, recreational, ceremonial and underground use. Many comments encouraged the FDA to think long and hard about their decisions because one wrong move could drive people into the underground where there are no safeguards. This sentiment was also echoed by the several veterans who cited having to seek psychedelics outside the country at high costs and to a danger to themselves.
Other commenters had offered solutions such as tailored systems, research grade wearables to track individual responses to room elements, remote controlled environmental settings, and non-restrictive settings.
Finally, I’d like to end with my favorite quote of the hearing:
“We should apply psychedelic exceptionalism only when truly necessary.”
Psychedelics are unique substances and while they are not better than any other substance, there are specific considerations that must be taken surrounding their regulatory approval to ensure the most accessible, affordable and safe route possible. These are not easy decisions and I look forward to seeing what happens next.
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