Welcome and Executive Order Overview
Lia Mix: Hello, and welcome. I’m Lia Mix, chief executive officer of Delphi. On April 18, President Trump signed the Accelerating Medical Treatments for Serious Mental Illness executive order (EO) [a presidential directive to federal agencies], directing federal agencies to fast-track development and patient access for psychedelic medicines.
We are joined today by Dr. Leith States and Ryan Roberts to discuss what the executive order means, what it does not mean, and what the field should expect from here.
Dr. Leith States is a physician and Navy veteran. He is also the former Acting Assistant Secretary for Health at the Department of Health and Human Services (HHS), where he served as the chief medical officer. Dr. States brings a federal health system perspective to this conversation: how executive orders move through agencies, what implementation actually requires, and where psychedelic medicine fits within broader public health, veteran health, and evidence-development priorities. He is also a board member of the Ibogaine Healthcare Policy Institute.
Ryan Roberts is a Marine Corps combat veteran and policy advocate whose work has focused on expanding responsible access to psychedelic therapies for veterans and others with severe trauma, addiction, and brain injury, with a particular focus on moral injury. Ryan was closely involved in the Texas ibogaine policy effort, which has become one of the most important state-level examples of how veteran advocacy, research infrastructure, and public policy can come together. He is also involved with the Ibogaine Healthcare Policy Institute and serves as a Delphi advisor.
I’ll start with a brief overview. Most of our audience will be familiar with this executive order by now, but the purpose of this conversation is to go a layer deeper and hear from perspectives informed by federal health policy, veteran advocacy, clinical research, and implementation.
The order has five main provisions:
- A Food and Drug Administration (FDA) priority voucher pathway, which can accelerate the review time for psychedelic therapies with Breakthrough Therapy designation [FDA status for drugs that may substantially improve treatment for serious conditions]. The FDA still decides which candidates qualify, and we have already seen three of those vouchers issued.
- A Right to Try pathway [a federal pathway for eligible seriously ill patients to access investigational medicines outside clinical trials], with direction to the FDA and Drug Enforcement Administration (DEA) to establish a pathway for eligible patients. This responds to case law that had moved in the other direction.
- Federal-state matching funds through the Advanced Research Projects Agency for Health (ARPA-H). These are not new appropriations; they are existing ARPA-H funds. The order directs $50 million to match state funds, such as the $50 million committed by the state of Texas.
- Interagency data sharing between HHS, FDA, the Department of Veterans Affairs (VA), and the private sector. This can feed into the clinical evidence pipeline for FDA evaluation.
- A timely rescheduling pathway, directing the attorney general and DEA to begin the rescheduling process once a psychedelic successfully completes Phase 3 trials [late-stage trials intended to confirm safety and efficacy].
Those are meaningful acceleration signals. But it is equally important to be clear about what the order does not do. It does not legalize or reschedule psychedelics. It does not create new appropriations. It does not change the FDA’s standards for approval. Agency authority remains with the agencies.
It also does not address the domestic supply chain issue for ibogaine. It does not address insurance coverage, reimbursement, or clinical delivery infrastructure, which are downstream but essential to real access.
With that frame, I’d love to hear from both of you: what does this executive order actually mean in practical terms for the psychedelic field and the future of access to these treatments? And just as importantly, what does it not mean?
What the Executive Order Signals
Leith States: I’m happy to start. Thank you, Lia, and thank you to Delphi for the invitation. Ryan, it’s always good to share the stage with you. Our backgrounds complement each other well.
In my former roles at senior headquarters levels within HHS, we received a constant flow of executive orders. Multiple things can be true at the same time. An executive order is worth the paper it is written on. It is also a very important permissive signal to agencies, the Executive Office of the President, and the broader ecosystem it addresses.
I see three major takeaways.
First, it creates a clear permission structure for the federal government. Since the EO was signed, and as I have continued to engage with friends from the FDA, VA, Department of Defense (DOD), DEA, and Department of Justice (DOJ), I see it allowing more effective and open collaboration between senior political appointees and career staff. That is an important nuance. Career staff have already been working in this area for many years, in some cases for more than a decade.
This is not a situation where Joe Rogan and the executive order show up, snap their fingers, and suddenly a drug is on the precipice of approval. That is not what happened. The EO does not slam anything home without respect for evidence, public health guardrails, public safety, the public good, or parity with other drug candidates. This class of drugs will still be considered with the same rigor, quality requirements, and safety expectations as any other drug candidate.
Second, the FDA has probably taken the most action in the days since signing. That reflects work already done and the fact that the FDA has been in the pressure cooker on this topic for roughly 10 years. We can look at the MDMA advisory committee process, the 2023 draft guidance to industry, and the line of Breakthrough Therapy designations for psychedelic candidates since 2017. There has been active work, thoughtful care, and tension with advocacy groups, pharma, and the outside world. Within that tension, there has also been incremental change. That helped prepare the FDA to take advantage of the opportunity this EO provides.
Third, this is a window of opportunity. Executive orders are only as valuable as the preparation, buy-in, and table-setting that exist among the people required to execute them. From what I can tell, there has been a good level of socialization, and people are taking the opportunity seriously.
The worst outcome would be that the EO gets signed, but everyone at the agencies has other work to do and drags their feet. Because it does not carry the force of law, does not bring new money, and does not create regulatory enforcement requirements, it could become another thing that does not have to be done. I do not think that will be the case, though there are dimensions of the order that may not be acted on.
Ryan Roberts: That is a helpful setup, Leith. I agree, and what I bring may be complementary. Some people may be asking what this means for the veteran community, which was cited repeatedly in the EO, including the suicide epidemic affecting veterans. I do not want to assume I speak for the veteran community as a whole. Since the executive order, we have seen a wide range of opinions from veterans: some strongly support it, some are supportive but cautious, and some do not think it deserves the praise it is getting.
A bit of my background helps explain my perspective. I am a combat veteran who came home looking for answers in a system that was excellent at stabilizing some of my symptoms and helping regulate many of the challenges I was facing, but that could not get me across the finish line toward a feeling of wholeness again. Through the veteran and psychedelic communities, I found my way to ibogaine-assisted therapy, which catalyzed a healing journey I am still on today.
That experience shapes how I view these medicines. Psychedelics are catalysts, not magic pills. That matters when we talk about the landscape these medicines need to operate in, because it differs in many ways from the current medical paradigm.
I also spent nearly two decades working in traditional Western medicine, from primary care to senior executive roles in academic medicine, clinical research, and oncology. I bring that experience to my work as a founding member of the Veteran Mental Health Leadership Coalition, where I work with many veterans and veteran supporters to move these medicines forward. That work helped pave the way for this EO.
As I have reflected on the executive order, I think it does what it is meant to do well. I am always looking for signal, and this does move the federal posture on a class of compounds that have been stuck in the mud for at least 50 years. It opens the regulatory layer. That is real and significant.
But the harder question is what the EO is not. It is not a finish line. It is not an access guarantee. If you think of this as a race, the EO speeds it up. It does not move the starting line or the finish line. It greases the wheels of a very slow process. We know that every day matters. On a conservative basis, 17.5 veterans die by suicide each day, not to mention suicide in the civilian population. Time is not in our favor.
For a veteran in crisis, this does not mean waking up the next day with a clear path to care. The race is still on.
There are layers to this. The regulatory layer is the one we are discussing first. The EO opens that layer. The second is the operational layer. Before the EO, the binding constraint was the federal review process: entering the Investigational New Drug (IND) process [FDA authorization to begin clinical testing in humans] and then clinical research. The EO moves the bottleneck downstream.
Now we have to ask: what about the workforce? What about facilities? What about payer coverage? What about preparation, integration, and six- to eight-hour treatment sessions? Those are now the things we need to think through.
Some of that is not in the EO because executive order authority only goes so far. It also reflects a federalist view: let the states and other responsible bodies work on those pieces, while the federal government does what it can.
The third issue is paradigmatic. We are working within a structure that is largely insufficient to capture what these compounds may offer. They sit at the seam between body, mind, spirit, and community. We hear this often from veterans who move through the medicine: yes, it helped with symptoms, but it also worked on other layers they were not prepared for or did not know how to handle once they got home.
The clinical paradigm catches part of the picture, but not all of it. Not everything veterans face is pathology. That is not a failure of the clinical paradigm. Boundaries exist for a reason; they allow depth, precision, and meaningful work. But if the clinical container captures only part of the picture, we need to create a seam between that paradigm and a community support paradigm. That is something no executive order will solve.
The acceleration on the regulatory piece is real. The operational gaps remain. The deeper question is whether the current paradigm can hold these compounds and the layers of experience they activate.
Agency Culture and Implementation
Lia: Both of you have made important points. Ryan, one implication of what you said is that where we may have felt we had more spaciousness on implementation, especially around training, workforce development, integration into the health care system, and related infrastructure, that timeline may now be more compressed.
We may have less time. As awareness of medicines like ibogaine increases due to the executive order, demand rises too. That creates a higher-pressure situation. The field needs to stay focused and keep its eye on the prize.
Leith, you noted that there is a standard non-enforcement clause in this executive order. That means it falls to the agencies and agency staff to move forward or not. You also said the EO gives existing staff more leeway, while some areas may still drag. Where do you expect acceleration, and where do you expect stickiness?
Leith: Each agency has its own culture, approach to work, and right and left lateral limits that define how it sees the world. The biggest contrast here is likely between the FDA and the DEA.
I want to be careful, because I have many wonderful colleagues at the DEA and DOJ. But the DEA views its role through the lens of the Controlled Substances Act (CSA) [the federal law governing controlled substances]. It has an outsized and at times appropriate interest in retaining positive control over situations involving controlled substances. Here, the specific issue is Schedule I [a federal category for substances with no currently accepted medical use and high abuse potential], especially as it relates to Right to Try.
Right to Try was an initiative from the Trump administration intended to increase access to investigational drug candidates for patients who otherwise could not access them during the clinical trial process. That includes people who are very sick, have more than one diagnosis, or have comorbid conditions that would otherwise exclude them from a rigorous trial protocol.
There are two important caveats. First, Right to Try is at the discretion of the sponsor, meaning the drug company. It is a voluntary program for them.
Second, Right to Try did not fully realize its promise for this class of drug candidates because it did not address the gap in the Controlled Substances Act for Schedule I drugs without currently accepted medical use. Right now, candidates such as psilocybin, lysergic acid diethylamide (LSD), and others remain in Schedule I. Even if there is strong Phase 2 or Phase 3 data, or Phase 1 data combined with unmet need and good safety data, a sponsor that wanted to provide the drug to patients outside a clinical trial would not be able to do so unless the DEA had a special registration pathway to monitor dispensing, administration, safety, and diversion control.
These operational details matter because they are what take an executive order from a signature and photo opportunity to something that actually affects patients.
One example where the rubber meets the road is the Freedom to Heal Act. The Veteran Mental Health Leadership Coalition and Reason for Hope have been helping move that legislation forward. It would create a DEA special registration pathway and fill a gap that is not fully recognized or discussed in the executive order. It is one of the lowest-hanging pieces of fruit that could answer the EO’s call and help patients now, even though many drug candidates still face a long time horizon before FDA approval.
That is an example where the FDA is not even the key actor. It depends on the DEA. Because there has already been significant input from the DEA about what would be needed to succeed, I think that piece has a strong chance of moving forward.
By contrast, the rescheduling pathway is different. The EO encourages the DEA to begin rescheduling after Phase 3 completion or submission, rather than waiting for final drug approval. But there is nothing regulatory that forces them to do this. It essentially says, “Please try to do this.” I do not get the sense that this will happen quickly. I still anticipate some foot-dragging because it will not be clear to the DEA that early rescheduling is useful, beneficial, or consistent with its CSA responsibilities without additional political change.
That is one area where we may see variable speed.
The VA is another important example. To its credit, the VA has had an integrated planning team for psychedelics since 2023. A few other HHS members and I were fortunate to serve as honorary members of that team. We have seen firsthand the intentional work the VA has been doing.
That includes clinical trials at nine different sites and attempts to expand the clinical trial footprint. It also includes strategic partnerships, workforce development, education and training, implementation science [the study of how to integrate evidence-based interventions into real-world settings], and careful socialization with career staff and political appointees. The VA has also done the work of taking pressure from Congress, providing hearings and testimony, and maintaining a constant presence.
The VA is complicated. It does not do everything well. But it is working on this intentionally, trying to move at a pace that respects the opportunity for veterans while also respecting the need to do so thoughtfully. The EO creates a window of opportunity and allows the VA to press the gas pedal more fully with the VA secretary’s permission and oversight, rather than doing this work in the shadows.
Lia: So the culture inside each agency, plus the infrastructure and work already done, will affect what moves quickly and where there is friction. You also called out legislation, which is not being discussed enough. Legislation is still needed. The executive order cannot appropriate money, and it cannot mandate many of the things that require action by Congress. That has not changed.
Ryan: I would add that, looking through an implementation science lens, the field needs meaningful and thoughtful ways to build shared perspectives around the problem.
The language is different across agencies and institutions. Their mental models differ. The way they define problems and solve problems differs. We need systems-level capability to look across the full range of organizations and departments working toward a shared goal. The question is how to keep them aligned, in good partnership, with shared language, goals, and objectives.
The Veteran Access Gap
Lia: Before we move on to audience questions, I want to give each of you a chance to say anything else you need to say about this executive order.
Ryan: From a veteran perspective, the EO will be a mixed bag. If you are a veteran engaged with or near a major academic medical center where Phase 3 trials or emerging trials become available, you may see a practical benefit. But that also means you are a veteran who meets the trial eligibility requirements.
Veterans with complex comorbidities and challenging life circumstances often do not fit those criteria. That is probably not the population this EO most seeks to serve. Of course, we want to help as many people as possible. But the highest-risk individuals, including those facing suicidality and suicidal ideation, often will not meet trial requirements.
We see this reflected in the fact that the VA has trials available and has been doing this work for a while, yet thousands of veterans still travel to Mexico for treatment that is not available here. So again, what the EO does well, it does well. But for many veterans facing urgent risk, it does not change anything in the near term.
That does not mean the field should let off the gas. It means the real work starts now. If summer is a true deadline for some pathways to become available, the field has to fill many challenging gaps. Every state will be different. We have already seen different approaches in New Mexico, Texas, and elsewhere. Some are federally aligned, and some are not, which matters for funding.
This is a complex set of opportunities and problems. The EO is a good signal and moves us in the right direction. But we cannot forget the other pathways to these medicines.
Lia: That is a good transition into the audience questions. It captures the tensions clearly: the EO is meaningful, but the field still needs to stay focused on access for the people who need these medicines most.
Real-World Evidence and Health System Integration
Lia: Our first question is from Kate Reynolds of Rocky Mountain Poison and Drug Services: If this accelerates the race to approval, could there be new energy to leverage existing real-world evidence to help ensure successful health care system integration? We know that it often takes many years, sometimes 14 or more, for a medicine to be fully integrated.
Leith: That is an excellent and timely question. It points to the EO’s data collaboration provision.
I want to connect that provision to the existing pipeline of relationships, agreements, and data sharing that was already happening. There are already data-use agreements, memoranda of understanding, and memoranda of agreement between the VA and HHS related to data sharing. That can include clinical trial data and, importantly, real-world evidence [clinical evidence generated from routine care or other non-trial settings].
This should advance implementation, harm reduction, public health protection, and care delivery. I do not see a pathway where that does not happen.
The proving ground will be the Veterans Health Administration (VHA). The VHA is the closest thing the United States has to universal health care from soup to nuts. It has an electronic health record (EHR), encounter data, and ancillary data that can help build real-world evidence.
Over the last year, the FDA under the new administration has leaned back toward real-world evidence and is reframing its approach. In terms of institutional change, that matters. The risk is creating a program within an agency that silos itself within a center or across centers, as happened previously with the FDA’s Real-World Evidence Program. Here, there is an opportunity to make real-world evidence useful and additive. I think this could be a strong use case.
Ryan: I would add that one positive feature of different state approaches is that they can function as living laboratories. Colorado and Oregon have one model. Texas has a federally aligned consortium model. Tennessee has another model, joining a consortium. My hope is that we can treat these state efforts as opportunities to collect real-world data.
I recently read that Jonathan Dickinson, co-founder of Ambio, had been contacted for data on ibogaine and on what Ambio has observed clinically. That suggests openness to learning from places where this work is already happening.
This is especially important for more complex medicines like ibogaine. The complexity is not only in the molecule itself; it is in everything required to support it. We need to absorb as much learning as possible from those already doing the work, because states will need to solve these problems in different ways.
The federal government appears to be signaling that, within certain guardrails, states may operate under models that make sense for them. We will see whether that changes at the federal level. But the point Kate raises is critical. If speed is necessary and summer is treated as a real deadline, even for populations such as treatment-resistant depression, these systems cannot be built overnight. They develop through iteration over time, and that requires real-world practice.
Right To Try, Sponsor Risk, and State Programs
Lia: Tony Coulson, a former DEA official, asks about Right to Try. Besides the DEA not yet providing a Controlled Substances Act pathway to the practitioner, there remains sponsor trepidation about adverse outcomes. Is there a way to create immunity for a sponsor?
Leith: In short, no. Right to Try is a voluntary program, and participation is the sponsor’s risk. There is no indemnification here. If a sponsor wants to participate, it can, but it does so at the risk of creating adverse event or severe adverse event data, which it likely does not want going into a drug approval process. That is the trade-off.
Lia: How do you see medical pathways for patented products affecting states with regulated programs using natural medicines?
Leith: Ryan alluded to this earlier. There will be tension between the approved-medicine pathway and state efforts through ballot or legislative initiatives for natural medicines, whether mushrooms, cannabis flower, or other natural products.
The approved-medicine pathway will likely be accessible to the fewest people for several reasons: cost, stigma, eligibility requirements, and general access constraints. A state-administered regulated market using natural products may need to be considered very seriously.
The EO does not address this at all. It does not mention the state’s experience in that context. It also does not address international implications, including the Nagoya Protocol [an international agreement on access to genetic resources and benefit-sharing]. There is a lot of messy tension that the EO does not speak to. Those tensions may create public health, public safety, and legal challenges.
Certification, Patient Safety, and Accountability
Lia: Michael Fratkin asks about practitioner accountability. Michael was a member of the Board of Psychedelic Medicine and Therapies, which was intended to be a certification board for psychedelic practitioners. That effort did not establish a structure capable of creating accountability and vetting psychedelic facilitators as a consumer protection entity. How important is this, and where might this work emerge?
Leith: I would say it is paramount. Ethics and patient safety protections are essential.
We have seen concerning events south of the border, including cutting corners and non-adherence to a regulated model, professional expectations, and institutional self-policing. There needs to be a standard, and probably more than one entity involved, because psychedelic therapists and facilitators operate across several disciplines. It is not only physicians and therapists. It also includes lay individuals with peer support backgrounds.
There will need to be a tiered approach. We need standards that can be promulgated across specialty and licensing communities. Some professional bodies have been reluctant to enter the fray, including the psychiatry and psychology associations. Other groups have weighed in more actively. There are also fledgling organizations that have attempted this work, but those efforts have not fully borne out.
So yes, I agree with Michael. This will be absolutely necessary.
Ryan: I would reiterate that if the end state is safe and effective access to lifesaving therapies, that does not exist without practitioner accountability and patient protection. For all the reasons Leith stated, this is critical.
Lia: It remains to be seen where the appetite to reapproach that work will come from in the field. But the need still clearly exists.
The Private Sector and Data Sharing
Lia: Lori asks, “What role will the private sector play?” How will agencies work with outside entities to push clinical trials and data sharing?
Leith: I will focus on one example: the VA, where much of the proving ground is happening.
In VA collaborations, there will be important touchpoints across clinical research, education and training, workforce development, patient protection, and implementation science. We are already seeing VA nonprofits, along with academic centers, fund existing psychedelic research trials within the VA.
There are also groups like Sunstone Therapies, where I am currently involved, working toward collaboration around education and training. One example is a trial with the state of Illinois, focused on training 200 therapists and treating 200 patients. The question is how to do that well under clinical trial expectations while also generating implementation science data.
That matters for two reasons. First, it is necessary and important. Second, as Ryan noted, the timeline has been compressed. If the voucher program accelerates approvals by shortening the duration of FDA review, and if the DEA shortens the rescheduling window, the VA may be expected to roll programs out at a few pilot sites sooner rather than later.
The private sector will likely need to help fill that gap because federal funding has not caught up. Given the budget cycle, actual increases in VA appropriations for medical services may not arrive until fiscal year 2028. That is where private-sector partners become important, especially during the acute rollout period, when there is an opportunity to protect the populations we are trying to serve.
Within the VA, that means veterans. But similar considerations apply to the broader safety net, including Federally Qualified Health Centers (FQHCs) [community-based clinics serving medically underserved populations] and Certified Community Behavioral Health Clinics (CCBHCs) [clinics providing coordinated mental health and substance use services]. These are settings where high levels of trauma, suicide risk, and need often converge. Strategic partnerships will be necessary there as well.
Lia: The EO’s data-sharing provision is helpful in that regard because it encourages private-sector participation and use of data.
We also have questions from Tony Coulson and Elliot Marseille that intersect around trust: Can we trust this? Can we trust that it is not just a political tool? How will it affect standards and rigor? We will have to wait and see how that plays out.
I appreciate both of you for your time, your work, and everything you are giving to this field. Thank you to the audience for joining us, and thank you to the Delphi team that helps host these Insight Sessions. We look forward to seeing you again on May 6, when Jonathan Dickinson joins our next Insight Session.
