Sarah Norman, MPP, executive director of BrainFutures.

Sarah Norman, MPP

The US Food & Drug Administration (FDA) held a public hearing on September 14, 2026, seeking testimony on provider training, patient safety, access, and data standardization for the potential therapeutic use of psychedelics.¹

The hearing arrived with late-stage candidates nearing regulatory review, including COMP360, a synthetic psilocybin for treatment-resistant depression, and DT120, a lysergide formulation with 3 positive phase 3 readouts in 

 and generalized anxiety disorders.²˒³ Compass anticipates launching COMP360 in the first half of 2027, pending FDA approval and Drug Enforcement Administration rescheduling, leaving little lead time for the psychiatrists, nurses, and therapists who would screen, dose, and monitor patients.²

In a NORC survey of 418 academic leaders released in December 2024, spanning counseling, social work, nursing, psychology, and other disciplines, 79% agreed psychedelics show promise for treating psychiatric disorders.

 Yet 92% said their programs lacked sufficient faculty to teach advanced coursework in psychedelic-assisted therapy, only 3% had built therapy-specific program tracks, and none offered a certificate.

In the following Q&A, Sarah Norman, MPP, executive director of BrainFutures, a national nonprofit advancing evidence-based innovations in brain health, discusses the hearing's takeaways, where credentialing and reimbursement stand, how psychedelic care may differ from esketamine and TMS, and why readiness cannot wait. She says there is no question that psychedelic therapies will become available in clinical settings. It is more of a matter of when and how we prepare before an approval.

Q&A: What the FDA Psychedelic Hearing Means for Psychiatrists

For clinicians who missed the FDA hearing on psychedelics, what were the top highlights?

 On September 14, the FDA held a 4-hour public hearing on the potential therapeutic use of psychedelics. About 80 speakers were selected at random from more than 200 requests. SAMHSA, NIDA, and the VA's Veterans Health Administration were on a listening panel alongside the FDA.

These are signals that implementation is a cross-agency issue, and this was not just a focus on drug approvals. Written comments are open until October 5 on regulations.gov, and folks who are interested in submitting comments should consider doing so.

We will be submitting written comments as well, likely in a joint response with other mental health organizations. Implementing psychedelics in a safe, ethical, and affordable way is going to require multiple organizations to come to the table to ensure we are truly ready for a new mental health and behavioral health intervention.

Our core message is that system readiness is critical. It appears the FDA is on the eve of approval of 1 or more psychedelic therapies, and therefore critical attention is needed to workforce development, training, and care models, as well as access, coverage, and reimbursement.

What gaps in provider training came up most often in the testimony, and how do they affect patient safety?

 BrainFutures is spending a lot of attention and focus to address gaps in provider training and patient safety. With psychedelics in particular, there are specific considerations around informed consent, given the fact that folks may be in an altered state of consciousness.

What we're trying to do is develop a framework that will build on top of current training and expertise. We completed an analysis of that and are now in a working group phase to ensure the evidence base, clinical expertise, and consumer voice are represented in developing a competency-based framework.

There was very consistent consensus around the notion that we need to think about provider training within a competency-based framework. That came out very loud and clear from the 80 speakers at the FDA forum.

Where does licensure and credentialing for psychedelic-assisted therapy stand today, and what needs to change before broader clinical adoption?

 There is emerging consensus, again, that this is not a specific type of provider. Rather, it builds on existing licensed professionals, such as psychiatrists, social workers, nurses, and peer specialists, with added competency-based training.

When you think about developing a care team that might deliver it, it's going to require bringing to the table the expertise of diverse professionals, including medical doctors, but also nurses, social workers, peer specialists, and others. Social workers, licensed clinical professional counselors, all those folks need to come to the table to develop and deliver this in a safe and ethical way.

If the FDA approves a psychedelic drug this year, how soon could psychiatrists expect credentialing and reimbursement pathways?

 It does appear the FDA is on the horizon of approving psychedelics pretty soon. After that happens, there will be a review and rescheduling [by the DEA], a process that can take approximately 90 days, and from there, additional steps are needed.

I think the critical point to take away is we're on the eve of approval, and we need to start to get ready today. We should have been getting ready previously.

What should psychiatrists treating MDD understand about how psychedelic care delivery might differ from ketamine, esketamine, or TMS?

 We can expect a new set of interventions for a variety of mental health indications: TRD, PTSD, and generalized anxiety disorder. For that set of diagnoses, the range of options patients, doctors, and psychiatrists can consider will probably shift pretty significantly.

I would also like to acknowledge that after these medications are approved for those indications, there are active investigations and clinical trials related to substance use disorder and other indications. It feels like a wave rolling out, with a lot of change going on.

I think it is likely psychedelics will not necessarily be the first line of treatment, as we've seen with Spravato and TMS, which have often been a secondary treatment option. That being said, they add a set of different interventions that can work when existing treatments are failing, so there's a different way to think through the algorithm. The evidence base is still developing around which treatments benefit whom, and when, so some of it is going to have to be informed by real-world evidence generation.

It's actually exciting that agencies like ARPA-H are investigating that. Which intervention works best for which patient? Is it going to be an SSRI, TMS, accelerated TMS, or a psychedelic, and which one?

We'll have increasing evidence we can use to refine the treatment algorithm. But for now, we do have some evidence we can use to tailor treatment, and an understanding of which interventions have what types of side effects.

What did the BrainFutures/NORC research find about academic capacity to train this workforce, and how large is the gap?

 In 2024, we worked with NORC to survey 400 academic leaders, and we released the findings in December 2024. It was a very rigorously done survey of academic leaders in disciplines such as social work, counseling, nursing, and psychology. Of those, 79% agreed that psychedelics show promise for treating psychiatric disorders.

Of respondents, 30% reported offering some sort of psychedelic therapy education, but only 5% include psychedelic therapy content in required graduate-level courses. It laid the groundwork, but there's a lot of work to do to ensure psychedelic therapy is addressed as we're training new clinicians.

The other thing that's absolutely critical is, while it's important to work with our new clinicians in training, the vast majority of therapeutic interventions today are provided by existing clinicians. That's why we are developing this competency-based framework, which can allow for scaling, train-the-trainer models, and other systematic ways to train existing clinicians.

For clinicians skeptical of psychedelic therapies, what is the strongest case for building readiness now rather than waiting for approval?

 It’s very clear an approval is going to happen very shortly. If [a clinician] waits until after approval, [they are] not going to be ready to answer the questions that come to the fore. The uncertainty of the timeline should not preclude us from starting the work.

I regularly present at national mental health organizations' conferences, and I am increasingly getting questions from psychiatrists whose patients are asking them about psychedelics today. They want to know how to answer that question today, because they know this is where patients are looking for additional or newer treatments to support them.

Given that approval is on the edge right now, workforce development isn't an overnight thing. If we wait a year until approval, we're really not going to be able to provide this service until years later.

The National Academy of Sciences did a famous report looking at the gap between a new treatment and it reaching patients, and it was 17 years. The reason is because people don't get ready.

A Call for System Readiness at the FDA Hearing on Sept. 14. BrainFutures. Published September 15, 2026. Accessed September 25, 2026. 

https://www.brainfutures.org/blog/fdahearing/

Dunlop B. COMP360 Psilocybin for TRD: What to Know Before a Possible 2027 Launch. HCPLive. Published July 17, 2026. Accessed September 25, 2026. 

https://www.hcplive.com/view/comp360-psilocybin-trd-what-know-before-2027-launch

Derman C. Voyage: DT120 ODT Reduces Anxiety in Phase 3 GAD Trial. HCPLive. Published August 12, 2026. Accessed September 2025, 2026. 

https://www.hcplive.com/view/dt120-odt-primary-endpoint--voyage-phase-3-gad-trial

New NORC/BrainFutures study finds psychedelics in healthcare practitioner training is growing. BrainFutures. Published December 11, 2024. Accessed September 25, 2026. 

https://www.brainfutures.org/blog/new-norc-brainfutures-study-finds-psychedelics-in-healthcare-practitioner-training-is-growing/

Articles

The FDA’s September 14, 2026 public hearing signaled imminent commercialization planning for psychedelic-assisted therapies, emphasizing cross-agency coordination (FDA, SAMHSA, NIDA, VA) beyond drug approval. Late-stage assets such as COMP360 and DT120 intensify urgency, with possible 2027 launch timelines constrained by DEA rescheduling and limited clinician lead time. Consensus testimony prioritized competency-based training, robust informed consent protections for altered states, and team-based delivery models spanning psychiatry, nursing, social work, and peer specialists. Academic training capacity remains insufficient, making scalable upskilling essential to avoid prolonged implementation delays.

As the FDA weighs its first psychedelic approval, Sarah Norman, MPP, says training, credentialing, and reimbursement are lagging while patients are already asking.