LIVE: HHS Secretary RFK Jr. and Veterans Affairs Secretary Douglas Collins Hold Press Conference

Thank you for being here with us today to kick off our exciting announcement. I'm happy to introduce HHS Secretary Robert F. Kennedy Jr. Thank you. Good morning, everybody. In April, President Trump signed an executive order directing HHS, FDA, and the Department of Veterans Affairs to accelerate research and potential treatments for serious mental illness, including psychedelic drugs. Today, Secretary Collins and I are announcing new investments to carry out that order with a focus on veterans and other Americans who continue to struggle with PTSD, with substance use disorders, and other serious mental illnesses. Yesterday, on Veterans Day, Americans recognized the service of our military veterans, our responsibility. It includes investing in research that could improve their care and giving vets accurate information about potential treatments. We're announcing two major investments today. We have a number of smaller announcements. First, HHS is committing up to $4.9 million through the Advanced Research Projects Agency for Health, ARPA-H, to advance Ibogaine treatment for PTSD. These awards will support scientific and regulatory manufacturing work necessary to prepare for future U.S. clinical trials. Mark Cuban, Cost Plus Drug Company, will develop the regulatory and manufacturing processes needed to produce a single molecule of ibogaine hydrochloride, in the United States for study for potential PTSD treatments. Mark Cuban's company has agreed to Cost Plus contracts. That are transparent. We're going to open source every aspect of this system so that we know that we're getting the best prices that we can possibly get and they'll be on the same commensurate with the kind of deals that we get from generic companies. Effort includes preparing an investigational new drug application, securing clinical grade, great Ibogaine, and developing sustainable manufacturing processes. Second, Beyond, a Texas-based company that operates in Mexico, has a hospital there, has treated more than 3,000 patients, 6,000 doses of Ibogaine, and the company uses the best kind of data protocols. It's evidence-driven, physician-led, hospital-grade treatment protocols. They've agreed to turn that research over to us and specifically to our page. That is going to allow us to dramatically accelerate the clinical trial process. We're going to have, I think, a record drug approval process. It will allow us to assess the clinical data. To help government research evaluate Ibogaine's safety, the dosing, protocols, the effectiveness, and the duration of any benefits. Another announcement, ARPA-H will also fund an additional effort to explore Ibogaine as a potential source for substance abuse disorder and for other indications. We expect to announce that award before the end of the year. The initial commitment spans five years. Teams must meet accelerated research milestones to receive continued funding. These awards fund development groundwork. They do not fund patient treatment or human subject research or authorize clinical trials or constitute an FDA approval. We must maintain those distinctions as this research proceeds. Researchers must establish whether Ibogaine can help patients identify who might benefit. Determine whether those benefits justify the risks. They must also investigate how long any improvement lasts. We will judge this work by the quality of the evidence. Our next announcement expands research beyond IPK. The National Institute of Mental Health has opened a $20 million funding opportunity to establish a research network focused on rapid-acting psychotropic drugs. The network will study treatments including ketamine, esketamine, psilocybin, and other emerging approaches for serious mental illness. NIMH expects to announce award recipients in the summer of 2027. This network will give researchers the structure for studying these treatments and generating To inform future care. We also want experts in the public to help inform the design of our Ibogaine trials. FDA has opened a request for information seeking comments, data, and recommendations on early phase studies. The agency seeks input on dose selection, participant eligibility, care settings, safety monitoring, stopping rules, and other forms of oversight. The comments are due on November 20th. I encourage researchers, clinicians, veterans, and families and other members of the public to contribute their comments. FDA will consider their input when reviewing the proposed trials. We will also require transparency from the teams receiving these awards. Awardees will share research data with the drug development community while protecting patient privacy. This is a very unusual invitation most of the time that these trials take place. The information is proprietary, and the drug companies do not share it. But in these trials, again, to accelerate the process and public access to these interventions, we are requiring the companies to open source all of their data so that the public will have the best information, that people will feel safe with the quality of the information that they're getting. And so competitors and other people who want to develop these interventions will have the immediate advantage of seeing. What works and what doesn't work. Negative findings can prevent researchers from repeating unsuccessful approaches. Evidence of harm can change development decisions. We need those results as much as we need evidence of benefit. We are addressing affordability during development as well. If this work succeeds and the medicine earns FDA approval, Our pricing will be comparable to that of other generic drugs, thanks to the agreement that we've made with Mark Cuban. Patients and families should understand that goal from the outset. These announcements build on the HHS-VA partnership to expand clinical research, share evidence, and prepare clinicians to deliver future FDA-approved treatments. I'm honored to be joined today by... I was honored with the efforts that Secretary Collins made to get here today. He didn't actually show up because of the shooting in Washington. I'm His building has been locked down, starting but Andrew Graddison is here to talk about the VA's role. You'll also hear from RPAH's Chief Medical Officer, Dr. Rabib Abdul, and CMS Administrator, to Mehmet Oz, FDA Acting Commissioner, Kyle Diamontes, and NIMH. speak Dr. Andrea Beckel-Mishner. Each will explain their agency's contribution. now. For veterans and families following this announcement, we recognize that research, all research, takes time. While the need for care continues, these investments pursue additional options. They do not change anybody's treatment today. Veterans should consult their health care providers before making treatment decisions. Any veteran in crisis and anyone concerned about a veteran can call 988 and press 1 to reach the Veterans Crisis Hotline. We owe veterans research that they can trust, accelerate accurate accounts of their results, and careful decisions about what comes next. And Andrew Graddison, I'm happy to be here to step in for Secretary Collins. Thank you for joining us. Thank you, Secretary Collins, and thank you for having the VA here at HHS. At VA, our mission comes down to one simple thing, putting veterans first in everything that we do. That commitment guides three priorities as we work to implement the President's Executive Order Accelerating Medical Treatment for Serious Mental Health. Veteran safety above all else. Second, advancing best-in-class research and study. What treatment for which veteran and to the extent we can learn it. Third, delivering timely, world-class care after new medicines are approved and come to market. For veterans living with PTSD, we owe them both urgency and the best science we can produce. In July, HHS and VA signed a historic agreement to break down silos and operate as one federal team. Today is the next concrete step to deliver on that promise. By combining HHS and ARPA-H's product development, manufacturing, and regulatory mission with VA's integrated health system, research, and clinical expertise, we are building the infrastructure. to answer critical questions for veterans while raising the standards we demand. Specifically, we're laying the foundation to study Ibogaine responsibly right here in the United States of America as a treatment for PTSD. This investment in today's announcement builds a consistent, affordable, clinical-grade research supply and will generate regulatory quality data. As we prepare to launch a clinical trial focused on safety, tolerability, and dosing, let me be clear, we are not taking shortcuts. Our clinical research will move forward with FDA authorization, independent ethics review, and strict patient monitoring protocol. While veterans travel internationally for these treatments today and their operations will inform our study design, that work internationally will not replace gold standard U.S. trials. Today's commitment is not a conclusion that Ibogaine is safe or effective for PTSD. It's a commitment to generate reliable evidence Be completely transparent about what science shows and expand access only if the data support it. This work is possible because VA and HHS have aligned leadership, expertise, and operational capability around one mission, better answers and better care for our veterans. Veterans deserve solutions backed by the best science America has to offer, and thanks to President Trump's leadership, together, VA and HHS are making sure they get it. Thank you, and I will turn it over to Arpa H. Good morning, everyone. Thanks for making time to be here. For those of you who don't know Arpa H, we are built with breakthroughs, paradigm shifts. And for the 14 million Americans who suffer every day with severe mental illness like PTSD, that's what we're about to give you, this collaboration with HHS and VA. My personal experience and my previous professional experience as an ICU doctor, I've seen all too closely what happens when the system fails those with severe mental illness like PTSD. And our system today is built on one-size-fits-all trial-and-error therapeutics. We deserve better. Our veterans deserve better. So today we're announcing the first phase of several investments that we're making, demonstrating how we're going to pursue that goal. The first thing we've done is we've obtained years' worth of international data from thousands of patients demonstrating safety and efficacy from our colleagues at Beyond that Secretary Kennedy mentioned earlier. We did this in an effort to expedite The speed of the process and gain insights without compromising the rigor and quality and safety that's necessary to bring a new therapeutic to the market. Secondly, we're funding multiple efforts for new investigational drug applications, the first of which is being done by Cost Plus Drugs. This project is going to establish the regulatory, clinical, and manufacturing basis here domestically in the United States to bring single molecule Ibogaine to the market. And they're doing it based on their business model. in a way that guarantees accessibility and affordability for every American. So with that, I'm going to turn it over to the man who needs no introduction, Dr. Mehmet Oz. I want to congratulate Rafid who did an amazing amount of work, and Matt Zorn, stand if you don't mind. And Steph, keep standing. These two people, keep standing. Thank you. Obviously, his secretary pulled us all together, and the people you see on stage here and many others, including some of the folks in the audience, were instrumental in pulling together what is a remarkable accomplishment in such a short period of time, building on what President Trump had demanded at that now iconic Oval Office event last April. Today's another unprecedented example of how we break down silos in this agency, and under Secretary Kennedy's leadership, we have been able to get folks to work together who never even knew each other's names in past administrations. Federal are important. We need them. They're important regulators. They're bureaucrats. We have become effectively regulators, agencies but most importantly, our superpower is actually the power to convene. you We get people to talk together in the private sector and in, frankly, the government itself that often does not happen enough. very Let me speak as a physician. Like Rafita, I spend a lot of time in an ICU because I'm a heart surgeon. I know what it's like to look someone in the eye who does much. not have another choice and take away whatever little hope they had. That first-hand experience connecting people with groundbreaking new therapies had changed my life, allowed me to find energy and practice the medicine, and many right now are looking for new therapies. It is maybe the most important thing we do in health care, to give people hope, real hope, not false hope. We're building on the kinds of insights that are currently available and not ignoring them with an old-fashioned paradigm that wasn't working anymore for their well-being. Nothing speaks to the PTSD crisis we have in America more than that reality. Our partners at RPH are leading the way in researching Ibogaine to your government. This FDA, and Kyle will speak in a second, can confirm that it's safe and effective. My job as the leader of CMS is to make sure they're reasonable and necessary in their application. These treatments need to work in the hands of 165 million Americans. Many vets, but all these 165 million Americans that are covered by federal insurance are the ones that we are particularly focused on, and that wisdom and the knowledge we gain from these experiences are going to help all the rest of Americans who are not covered by federal insurance. Our mission, as always, is to protect the most vulnerable, especially patients and veterans on our program suffering from serious mental health conditions of all types. Today we're focused on PTSD, but others will benefit as well. So what's the stake we have in promising new therapeutics? We want to make sure we can cover patients appropriately when they need care, whether it's in the context of a clinical trial or establishing the right coverage and payment rules once we've confirmed evidence of the efficacy of these medications. Accordingly, Medicare and our innovation center, CMMI, led by John Brooks and Abe Sutton, are exploring paths to provide wraparound coverage to support patients as they embark on the recovery. So if you get access to these medications, and ideally over the next several months, the clinical trials, the first phase, will show they're safe enough to be used more broadly, we'll be able to provide some support to provide for the clinicians and clinics that will be administering these. Products, maybe not the products themselves, but the surround care. In addition, we can support clinical trials and state demonstrations. Perhaps if we work things out, there will develop more evidence base for future FDA and Medicare decisions. We want to ensure that we have the right people giving the right medications in the right places. And this agency will do its job to make sure that you have a right to try. Kyle, our fearless leader of the FDA, Kyle DeMarcus. Thanks, Dr. Huston. Well, today's a great day for our veterans. They put their bodies, their minds, their lives on the line for us each and every day. And in return, we owe them access to potentially beneficial treatment options for the wounds. Coming right after Veterans Day, this announcement is especially big. I want to thank President Trump, Secretary Kennedy, Secretary Collins and his team for their bold leadership. FDA is proud to stand here today with HHS and ARPA-H, as well as our colleagues at CMS, as they announce new research teams to build clinical trial frameworks for IVD. Alongside that, the National Institute for Mental Health is funding research in a rapid action this past summer. HHS, the FDA, and the VA signed a memorandum of understanding to carry out the executive orders on these candidates. The FDA is committed to open-minded evaluation of new therapeutic approaches to help veterans. And to our duty to make sure that these new therapies can reach the market. Together, we're honoring our heroes by turning old questions into real products. I do apologize, I'm double booked, but before I run off stage, I want to hand it off to Dr. Andrea Beckel-Michner. She's the Acting Director of the National... Thank you, everyone, and good morning. I'm honored to join these leaders on the podium to expand on the announcement I just announced about the new investment that NIMH is rapid acting. These hypertrophic so Psychotropic drugs are a new class of compounds that we think really have this rapid onset and a sustained duration of treatment. In anticipation of this new class of drugs being approved by FDA, the NIMH is really pleased to announce a $20 million investment, $10 million in this fiscal year and another $10 million next fiscal year to support new studies that we'll add to the research portfolio. The goals are to deliver treatment safely, consistently, and sustainably, always with an eye to improve outcomes for patients, including veterans and all of the Americans that suffer from serious wounds. This is an effort to scale up in coordination with the groups that are on stage and beyond. Initially we're hoping to support a data coordination center so that we can harmonize all of the data that are collected across the studies. These are for trials in real-world settings. It's very important. The results will inform health care uptake, service delivery, optimal training, and workforce demands. Those models will be very important going forward as these treatments are made more available to Americans. The potential use and utility of adjunctive psychotherapy is a potential research direction, And looking for optimal re-treatment frequencies. It's a question that has not yet been answered. So we're very proud to make this announcement today. It is actually on the street as of this morning. So we invite all of the research community and scientists and physicians out there to take a close look at that. We're looking forward to seeing you out there. Great. Thank you all to our fabulous speakers. We are now going to open up for Q&A. I ask that if you have a question, just raise your hand, state your name and outlet into the microphone so we can hear you. And he's starting to speak. Hi, thanks for doing this. Sandhya Raman with Bloomberg Law. A lot of this is early stage, looking at the possible ways we can use these as treatments. Do you have a timeline from when you might see some of this maybe come to fruition if the research pans out? Thanks for the question. The timeline is going to adhere to typical FDA policies, but I can tell you that we are making record time. Partially, the way we do that is we actually have, it's built into the design of how ARPA-H works in that we take multiple shots on goal. So there's actually multiple entities and teams that are filing INDs. And again, the reason that we procured the data from the BEYOND group was to expedite that speed, right? So we wanted to show our commitment to getting this done as quickly as possible on behalf of not just the veterans, but every American, but also doing it without compromising safety or rigor. Awesome. Thank you. Anyone else? Okay. Thank you all so much for coming here this morning. I really appreciate your time and have a great rest of your day. Thanks everyone.