An Update on Our FDA Call to Action and How Your Voice Is Being Heard

Earlier this summer, we launched our FDA Call to Action: Drug Repurposing to Address Unmet Medical Needs, inviting our community to help advocate for the on-label indication of IV ketamine for the treatment of depression. Now, we’d like to share with you a status report on the measure, and let you know what we submitted on behalf of our patients.

The community is showing up

When the FDA opened its request for public comment, we didn't know how many people would respond to our call. The picture is encouraging: as of July 6, 2026, the docket has received 455 comments in total, and 221 of them concern ketamine in regards to depression. That's close to half of every comment advocating for the on-label status of ketamine for mental health issues, and we’re proud to have served as a driving force in this groundswell.

Co-Founder Dr. Nico Grundmann co-authored a comment submitted by the board of American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP3) in conjunction with Brain Futures, summarizing the significant evidence for ketamine for depression, bi-polar disorder, and acute suicidality, outlining the importance of the FDA making these indications on-label for generic ketamine through these new regulatory pathways. You can read the formal submission here.

In our own submission to the FDA, we wrote about the long road patients travel before finding relief, the safety and continuity of care that make treatment work, and the insurance barriers that put maintenance care out of reach for many. This comment was informed directly by what our patient community has told us over years of conversations, surveys, and shared stories. You can read the formal submission here or scroll below for the full copy.

What we said to the FDA

Our submission, authored by Tiffany Franke, Co-Founder and Chief Experience Officer, drew on nearly a decade of caring for patients with depression. It made a few core points:

• Most people arrive at IV ketamine care after years, and often decades, of treatment that didn't work, including multiple medications, therapy, intensive outpatient programs, and hospitalization. For many, IV ketamine is the intervention that finally provided relief from depression.
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• When it comes to safety, the model of care delivery is just as important as the medication itself. Ember has committed to maximizing patient safety through a 1:1 patient-to-clinician model, with clinicians trained in medication administration, emergency response, and psychological support. This is a resource-intensive model, but one that allows patients to feel safe, release, and do the work of healing.
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• The barrier patients name most often to pursuing continuous care is affordability due to lack of insurance coverage. Because IV ketamine remains off-label for depression, insurers frequently cite the off-label status when they deny or limit coverage. As a result, patients often delay care, stretch out the intervals between medically appropriate visits, take on second jobs to afford treatment, or move to lower-cost options that are often less effective and may offer less oversight than the FDA itself has deemed appropriate.
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• An on-label indication could change that, opening clearer pathways to coverage so that treatment becomes a routine healthcare expense rather than an out-of-pocket burden.

Most importantly, the submission cites patients' own words on how safe treatment alleviated their depression, and why access is the thing that would help most in pursuing care.

There's still time to add your voice

Since our original call to action, the comment window has been extended. The FDA is now accepting comments through July 13. If you've been meaning to submit, or if a friend or family member has a story worth telling, now is the time. See here step-by-step instructions on how to share your experience.

Opportunities like this are rare. For years, there was no clear pathway to add a new indication to a generic medication like ketamine, even with a large and growing body of evidence behind it. The FDA's request for information is a real opening, and public input is part of how the Agency decides what to prioritize.

We don't know how the FDA will ultimately respond. What we do know is that this community has already made itself heard in a meaningful way. Thank you to everyone who has submitted a comment, shared the call to action, or trusted us with your story. We are grateful to link arms with you in advocacy.

Submit your comment to the FDA →

Our Letter to the FDA

Comment Submitted by Tiffany Franke, Co-Founder of Ember Health in New York City, June 11, 2026

I am writing in response to the FDA's Request for Information: Drug Repurposing for Unmet Medical Needs [FDA-2026-N-4492]. I respectfully urge the Agency to prioritize evaluation of racemic intravenous (IV) ketamine for Major Depressive Disorder (MDD), a condition affecting millions of Americans for whom existing treatments frequently fail to provide timely or meaningful relief.

Thank you for providing the public an opportunity to share perspectives on how existing therapies may address serious unmet medical needs. The experiences I share below are informed by nearly a decade of direct engagement with individuals living with depression and seeking relief through evidence-based ketamine treatment.

My background and perspective

I am the Co-Founder and Chief Experience Officer of Ember Health, a specialized IV ketamine practice in New York City. Over the past eight years, our team has cared for more than 2,500 patients and delivered over 40,000 ketamine infusions. During that time, we have systematically collected patient feedback and outcomes data, and observed meaningful symptom improvement in 84% of the people we’ve served. These outcomes were determined by our data partners at Harvard Medical School, Massachusetts General Brigham, and are pending publication in peer reviewed journals as organized by MGB.

My role has included designing patient experience systems, building referral partnerships with mental health providers, developing clinical support programs, and most importantly, listening to our patients.

I have personally reviewed hundreds of patient surveys and conducted hundreds of one-on-one conversations with patients seeking relief from depression. Through these interactions, I have learned about the long and difficult paths many individuals travel before arriving at ketamine treatment, the impact effective treatment can have on their lives, and the barriers that continue to prevent access to care.

The stories and observations shared below represent the experiences of patients whose lives have been directly affected by Major Depressive Disorder and whose access to treatment continues to be constrained by ketamine's current regulatory and reimbursement status.

An unmet need affecting millions of Americans

Major Depressive Disorder remains one of the most significant public health challenges facing the United States. Approximately one in ten American adults experiences depression, representing millions of people whose ability to work, care for family members, maintain relationships, and participate fully in society is impaired.

The individuals we serve reflect the extraordinary diversity of this population. They include healthcare administrators, public employees, attorneys, therapists, parents, artists, retirees, educators, and students. They come from different backgrounds, professions, and stages of life.

While they are demographically diverse, they share a remarkable resilience. Most have spent years pursuing relief through conventional treatment pathways before considering ketamine treatment.

The treatment journeys that bring patients to ketamine care

Most of our patients arrive after years, and often decades, of unsuccessful treatment attempts. Many have tried multiple antidepressants, psychotherapy, intensive outpatient programs, hospitalization, electroconvulsive therapy, and other interventions. Many have struggled with depression since childhood, and yet our average patient age is 42 years old. Often they develop severe symptoms following trauma, loss, or major life transitions. Many describe reaching ketamine treatment only after exhausting virtually every other available option.

The following statements are direct quotations from patients who consented to sharing their experiences:

“Before, I had frequent suicidal thoughts and constant existential dread.”

“I could barely exist outside my bed.”

“I was depressed to the point that it was affecting my ability to function.”

“I was experiencing a deep depressive episode before starting at Ember, including suicidal ideations and self-harm.”

“I have had severe CPTSD since childhood.”

“I had tried nearly all psychiatric interventions (medication-based) for depression and nothing I used was providing relief from depressive symptoms (fatigue, loss of interest, distance from myself/relationships/feelings).”

“I had extreme anhedonia and was really struggling with motivation. I had all the tools to feel better - journaling, meditation, exercise, diet - I just couldn’t bring myself to care about or try anything. I was sad more often than not, often thinking fondly of suicide as a relief from what felt like inevitable pain, and somehow also boredom, for the next 50 years. I was isolating, pushing people away and having trouble engaging with others.”

“My situation before coming to Ember was that I was experiencing a long episode of depression over the past year or so, passive but consistent SI, and so much guilt around feeling joy or taking care of myself. I felt like I couldn't connect with people as authentically as I wanted, and could only feel small amounts of happiness.”

“After 32 years of being treated for bipolar, I have been on so many psychiatric drugs of various kinds; I've had a myriad different modalities of therapy including several rounds of ECT.”

“I was mostly spending the days lying down in my apartment, watching tv. Anytime I tried to get out of this pattern I wasn’t able to sustain the change for more than a few days.”

“I felt extremely overwhelmed by my symptoms. Mostly stuck in a loop that I needed to make changes to my life but lacked the motivation, energy or concentration to take the steps I needed.”

“Exactly 4 weeks before my initial call, I attempted to end my life and ended up staying in the hospital for a week. I had been suicidal for over a year at that point, largely due to PTSD from sexual assault.”

“I was exhausted by the many, many different prescriptions I had been on throughout my life that continued to fail me.”

What safe IV ketamine treatment looks like in practice

In our experience, successful ketamine treatment depends not only on the medication itself, but also on the clinical environment in which it is delivered and the continuity of care that follows. This is why the FDA’s request for information is so important, as the public trusts the FDA to set safety standards for medications in healthcare, and the opportunity to enact more rigorous safety protocols feels key to ensuring ketamine’s medical utility.

In our practice, treatment begins with an initial "Foundation Series" of four infusions over two weeks, which serves as an initiation series. This initial phase is designed to assess for meaningful symptom reduction and establish a therapeutic response, during which time 84% of our patients have experienced significant relief, as measured through PHQ-9 survey data and a protocolized outcomes assessment. However, for many individuals living with chronic or recurrent depression, ketamine treatment is not a one-time intervention. Like many treatments for chronic medical conditions, its benefits must be maintained over time.

Patients who initially respond positively typically transition into a long-term maintenance plan informed by ongoing symptom monitoring, clinical assessment, and coordination with their broader mental health team. In our practice, patients who remain in maintenance care receive a booster infusion once every six weeks on average, though individual needs vary considerably. Many patients have successfully maintained improvements in mood, functioning, and quality of life through this approach for years. At Ember, we have collectively provided over 7,000 life-years of care to our clients.

This longitudinal model of care is critical to understanding both the effectiveness of treatment and the impact of insurance barriers. When coverage is unavailable, patients are often forced to delay, reduce, or discontinue medically appropriate maintenance care, leading to symptom recurrence and the loss of benefits they worked hard to achieve.

In our clinics, we deliver every infusion within a 1:1 patient-to-clinician clinical care model in which a patient is continuously monitored by a dedicated clinician throughout treatment. These clinicians are specifically trained in intravenous medication administration, physiological monitoring, and emergency response, ensuring that patients receive care in a medically appropriate setting. Equally important, they are trained to provide psychological support during what can be a deeply vulnerable and emotionally significant experience. We feel it’s critical for patients to receive a comprehensive model of care designed to maximize safety, support therapeutic benefit, and ensure continuity of treatment over time.

While ketamine itself is an inexpensive generic medication, the care model required to deliver treatment safely and effectively is resource intensive. Patients consistently emphasize the importance of clinical supervision, psychological support, and continuity of care in achieving positive outcomes.

“Ketamine is a vulnerable place to be. You're in a room with one other person, and you are having a complex dissociated experience, and you're vulnerable. And if I didn't trust the other person in the room to have my back, that would change everything.”

“When it comes to mental health, the structure of a safe place to be, to talk about things, is everything. And Ember provides that safety. It makes it seem like things are going to be okay when you're there.”

“Everybody at Ember is very attentive. I feel totally taken care of. I feel totally safe. In the treatment, there's a person with you the whole time. I've been having this treatment for two years maybe, and I had one bad one, and the person was right there with me and helped me out of it.”

“One of the only reasons that I was willing to do it is because I knew that someone would be in the room with me the whole time.”

“At Ember, there's a clinician with you at all times. In fact, it's not just a human, it's a clinician, somebody who can take care of you no matter what happens.”

“It's really important to me that Ember Health clinicians have experience in advanced airway management, that if something happens, they know how to help.”

“There's a real peace of mind knowing that you're going to be very vulnerable and you have somebody who's going to help you and take care of you. We're human beings. So many things can happen, so many things can go wrong. And the staff at Ember are trained to take care of any eventuality. So they're right there for you.”

“As you know, I can be the poster child for Ketamine infusions and Ember Health. I am so grateful to be part of this amazing team of professionals. I feel that my health is a team effort and I am a valued member, not just a patient. The compassion and care is remarkable. At Ember Health I FEEL taken care of. I feel like I can let go and just be my vulnerable self. Thank you for creating a truly safe space for me to heal.”

“Ember is central to my care plan. The extent to which other aspects of my care plan help, like conventional medication, is due largely to ember / ketamine iv, I think. I've noticed that if I extend my monthly cadence by even a week it adversely impacts all other aspects of my care plan.”

The Impact Patients Report

The outcomes patients describe are often profound. We frequently hear reports of restored functioning, improved relationships, reduced suicidal thinking, renewed engagement with work and community, and a return to activities that had become impossible during severe depressive episodes. Many patients describe ketamine treatment not as a cure, but as the intervention that finally made recovery feel possible.

The following statements are representative of the feedback we routinely receive:

“I understand what it means to be happy for the first time.”

“There’s been a direct correlation between my infusions at Ember and my recent resurgence of creative energy, self-care, and general wellbeing.”

“I can now perceive myself, my thoughts and feelings, my relationships and the world in a new way, and coexist with the traumas I’ve endured but not be ruled by them.”

“It gave me freedom from the burden of intense depression.”

“Transformative; the experience opened up my world from dull and grey to bright and colorful.”

“Ketamine infusions haven’t been a cure-all, but I’ve managed to find motivation in some places. I’m able to mindfully remember how I felt when I was in treatment and experienced overwhelming love and the reality that none of these small things matter. I’m learning to experience and sit with my emotions but also, and more importantly, that my circumstances aren’t set. I can change how my life looks if it feels right. Even on low days that feels like a victory.“

“Today, I no longer have suicidal thoughts, I am drinking alcohol a lot less, have better sleep habits, I'm working a lot less - my overall habits have improved leaps and bounds. I am kinder to myself and have more hope in life.”

“I've struggled with depression for the last 3 years, and ketamine finally gave me the relief I needed.”

“It has greatly helped me. The ketamine helps stabilize my mood. My baseline is way higher - my lows are not as low, and when I do get low, I recover much more quickly.”

“My infusions at Ember are the most critical factor in my depression management.”

“It has been immensely helpful as a resource for sudden onset of major depressive symptoms.”

“Ember has been the main source of my treatment for the last 18 months and usually has helped me to avoid major depressive episodes.”

“Probably the single biggest positive factor in my mental health.”

“Honestly, it’s miraculous.”

The barrier patients discuss most often: Affordability

When we ask patients how care could be improved, the most common answer is affordability. The most significant barrier our patients report is not treatment efficacy, safety, or willingness to engage in care, but rather the inability to access and continue treatment because of cost.

Many patients encounter repeated insurance denials. Others receive only minimal reimbursement despite maintaining out-of-network benefits. Many report that insurers cite ketamine's off-label status when denying or limiting coverage. As a result, patients often delay treatment, extend intervals between medically appropriate visits, discontinue care prematurely, or seek less effective alternatives that are more likely to be covered.

The following comments are representative of what we hear:

“My insurance caps my reimbursement at a much lower rate than what you charge, so I pay a lot out of pocket.”

“My insurance company has been refusing to consider coverage for almost a year.”

“Because financing treatment is such an intense part of this process- supporting patients in insurance endeavors… would really change access for a lot of people.”

“My insurance has stopped covering it even with out of network benefits. I have had to take on additional employment outside of my day job specifically to afford my treatments.”

“I wish it wasn't so expensive or was more covered by insurance.”

“Ember Health has been great, and essential to rebuilding my mental/emotional well-being... At the moment, unfortunately, the economy is a fundamental barrier to coming in for an infusion unless it was an extremely urgent need that couldn't be resolved otherwise.”

“The only thing that could improve would be if insurance would cover.”

“Finances have been a significant reason I don't have treatments as often as would be helpful for me personally.”

“Continuing care for me is purely financial unfortunately.”

“I know folks at Ember have been trying to get insurance companies to cover ketamine treatments in-network. Please keep trying.”

“I could not possibly put into words the impact that ketamine has made on my life... The only issue I've had related to the treatment involves insurance.”

“The biggest change Ember Health could make at this point is being in-network with my insurance, Anthem BCBS.”

“It’s just really expensive... I know this treatment is the most effective thing for my depression but rising costs in other areas of my budget make it challenging to come in as much as I know is needed to get the best result.”

Many patients who can no longer afford IV ketamine treatment pursue alternative treatment pathways that are less expensive, more readily reimbursed, or more easily accessible, even when those options may not align with the treatment approach that previously provided meaningful relief.

Some patients transition to FDA-approved esketamine products because insurance coverage makes them financially accessible. While esketamine is an important treatment option and has expanded access to ketamine-based care, many patients report having previously achieved better outcomes with intravenous ketamine. In these circumstances, reimbursement policy instead of individual outcomes and clinical guidance can become the primary determinant of treatment selection.

Others pursue compounded ketamine products intended for at-home use because they are less expensive per session than medically supervised IV treatment. Patients frequently describe making this choice not because they prefer unsupervised treatment, but because cost leaves them with few alternatives.

This trend is particularly concerning given the FDA's public communications regarding compounded ketamine products. In 2023, the FDA issued a warning highlighting risks associated with compounded ketamine products used outside of medically supervised settings, including concerns related to monitoring, dosing, sedation, dissociation, increases in blood pressure, psychiatric adverse events, and the potential consequences of administering ketamine without appropriate medical oversight.

As a result, many patients face a difficult choice: discontinue a treatment that has meaningfully improved their lives, switch to a treatment selected primarily because it is reimbursed, or pursue lower-cost options that may provide less clinical oversight than the FDA has indicated is appropriate. In our experience, this is one of the clearest examples of how the current regulatory and reimbursement landscape can inadvertently steer patients away from the care model that best balances safety, efficacy, and long-term outcomes.

Conclusion

The purpose of drug repurposing is to identify existing therapies with sufficient evidence to address serious unmet medical needs. Intravenous ketamine represents precisely such a case.

Major Depressive Disorder affects millions of Americans and remains a leading cause of disability, suffering, and suicide. Many patients do not achieve adequate relief through existing treatment options. At the same time, intravenous ketamine has accumulated a substantial body of clinical evidence, decades of real-world experience, and a growing record of meaningful patient outcomes.

The patients whose experiences are reflected in this comment are asking for broader access to a treatment that has substantial safety and efficacy data, and that has changed their lives for the better.

I respectfully urge the FDA to prioritize evaluation of intravenous ketamine for Major Depressive Disorder and to consider the significant public-health benefits that could result from formal recognition of this evidence-supported use. 

If further details of any of our patient data or outcomes would be helpful to the FDA, please contact us at info@emberhealth.co, and we would be happy to provide direct access for the FDA to our records for review. We have already partnered with the American College of Emergency Physicians, to submit a Broad Agency Announcement of our treatment visit and safety data, currently under FDA review (FY26C3CP16).

Thank you for your consideration and for the Agency's commitment to advancing treatments for Americans living with serious unmet medical needs.