Protecting Public Health and Safety with Psychedelics Advancing Therapies (Path)

Floor Speech

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Mr. BERGMAN. Mr. Speaker, I rise today to include in the Record an updated open letter from myself and Congressman Correa. the founders of the PATH Caucus, to ensure stakeholders have a voice in crafting the rules and regulations surrounding psychedelic assisted treatments. This is an updated version of the letter from my previous submission to the Record on August 9, 2024. It serves to extend our requested deadline for responses to February 28, 2025.

Dear Commenter: In 2022, a new Congressional caucus was created to raise awareness among federal lawmakers about the therapeutic potential of psychedelic and entactogenic drugs to treat several mental health conditions that were refractory to contemporary evidence-based therapies. The Congressional Psychedelics Advancing Therapies (PATH) Caucus aimed to accelerate and support clinical research in the use of these novel substances, specifically psilocybin and 3,4- methylenedioxymethamphetamine (MDMA).

To better inform Congressional members, the bipartisan PATH Caucus is seeking input on how to implement programs and policies that address the range of complex issues with potential novel therapies that may use a psychedelic or entactogenic drug in medically supervised and interpersonally supportive settings.

To gain a more complete understanding of the issues associated with use of these substances, the PATH Caucus believes that taking an inclusive, intentional, and reasoned approach to gathering input from the public may engender valuable insights that can more accurately and comprehensively characterize how different modalities incorporate the use of these substances while also ensuring responsible, accountable, safe, and ethical use. We seek information from the general public, those who have received psychedelic-assisted therapies as an intervention, interested stakeholders, and those individuals and entities working within the bio-psycho-social-spiritual behavioral health ecosystem (e.g., palliative care, addiction services), which stresses a holistic system of care comprised of clinical providers, counseling, and peer support (Courtney et al., 2023; D'Souza, 2007; Urutia et al., 2023).

It will be essential to receive input from people and organizations with specialized experience in implementing therapies where psychedelic or entactogenic drug substances are administered, such as in clinical research protocols (e.g., depression, palliative care, substance use disorders, post-traumatic stress disorder (PTSD)), or experience in training others for such therapies. As a part of the PATH Caucus information gathering effort, we acknowledge the significant anthropological role of certain psychedelic substances such as ayahuasca, peyote, and Psilocybe mushrooms. Some indigenous peoples of the Americas have extensive traditions dating back hundreds to thousands of years, where they incorporated these substances into spiritual ceremonial or ritual healing practices. The PATH Caucus believes that respectful, inclusive, cultural knowledge sharing from these communities may provide substantial insights, further informing our overall understanding, and we welcome their input.

In medications derived from psychedelic or entactogenic drug substances are ultimately approved for therapeutic indications by the FDA, it is important for States to understand the risk mitigations frameworks FDA has established and develop ways to make sure they are supported. Aspects of real-world risk reduction and mitigation frameworks may include, but are not limited to, providing comprehensive transparent public education, implementing substance misuse prevention programs, minimizing the potential for adverse reactions, and developing implementable risk mitigation, safety, and ethical monitoring strategies. Moreover, it will be vital to consider how Congress can best support states in developing and adopting scalable infrastructures and sustainable service delivery systems that ensure proper accountability and monitoring, as well as facilitate access and equity in utilization, with a particular focus on communities that may be at risk for experiencing inequities in care resulting in disparate health outcomes (e.g., veterans, the uninsured, those who are experiencing homelessness, people with lower incomes, and individuals living with mental illness and/or co-occurring substance use disorders; Ortiz et al., 2022). In addition, when federal agencies such as the Department of Veterans Affairs make these products available, we need to be sure there is sufficient infrastructure to ensure patient safety. All of these components, when collectively addressed, may contribute to more responsible, accountable, safe, and ethical use of psychedelic and entactogenic derived substances in medically supervised and interpersonally supportive settings.

The PATH Caucus seeks input that can inform Congress so any potential future appropriations will support states collectively addressing the relevant issues and support necessary federal initiatives such as research, implementation and FDA regulation. Congress believes that by listening and learning from the broader ecosystem, staying abreast of potential innovative evidence-based therapies that may treat individuals with behavioral health disorders refractory to current treatment modalities, and simultaneously undertaking proactive measures for developing real-world risk reduction and mitigation frameworks, will help protect public health and safety. Current State of Psychedelic and Entactogenic Clinical Research

Clinical data continue to be collected regarding the safety profiles and potential benefits from therapies that use psychedelic or entactogenic drug substances across a variety of diagnoses such as major depressive disorder (MDD), treatment resistant depression (TRD), demoralization, PTSD, generalized anxiety disorder (GAD) and substance use disorders, in conjunction with appropriate supervision and support from qualified mental health professionals (Belouin et al., 2022; Carhart-Harris et al., 2021; Davis et al., 2021; Griffiths et al., 2016; Jerome et al., 2020; Mitchell et al., 2021; Ross et al., 2016; Siegel et al., 2021; Xi et al., 2023). Additionally, FDA has granted requests for Breakthrough Therapy designation to specific development programs involving MDMA for the treatment of PTSD (Multidisciplinary Association of Psychedelic Studies, 2017), psilocybin for TRD (COMPASS Pathways, 2018; Goodwin, G.M.. et al. 2022) and MDD (Khan, 2019; Raison et al., 2023), CYB003 for MDD (Cybin, 2024), and MM120 (lysergide d-tartrate) for GAD (MindMed, 2024). The Breakthrough Therapy designation process facilitates and expedites the development and review of certain new drugs that have the potential to address unmet medical needs. This designation is available for drugs that are intended to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available treatments on clinically significant endpoint(s) (U.S. Food and Drug Administration, 2022). It should be noted that a Breakthrough Therapy designation does not mean that the FDA has made a safety or efficacy determination for a drug, and the Breakthrough Therapy designation is not a substitute for marketing approval. Currently, FDA has not approved any drug containing MDMA, psilocybin, psilocybin analogs, or LSD or other psychedelics or entactogens as being safe and effective for any therapeutic indication(s). Acknowledging the Need to Address Complex Issues

Use of these substances is not without risk. A psychedelic (e.g, psilocybin) or entactogenic (e.g., MDMA) drug can temporarily alter a person's mood, thoughts, and perceptions, and lead to heightened suggestibility, anxiety/panic, and/or paranoia, among other outcomes. For psychedelics, a participant can experience vast changes in their perceptions of reality, including time and space. Moreover, an individual can become extremely sensitive to internal and external stimuli and altered in their cognitive functioning and visuoperceptual skills. Knowing these realities, any therapy that uses psilocybin or MDMA, for example, should involve thorough participant screening, education, and preparation, supportive settings, and close supervision by credentialed and qualified medical and mental health professionals to maximize safety and promote potential therapeutic outcomes (Davis et al., 2021; Johnson et al., 2008; Nichols, 2016; Phelps, 2017).

Furthermore, acknowledging that it has been suggested that some therapies could potentially lead to blurring of ethical boundaries between participants and provider(s) in some cases, as well as the potential for enhanced suggestibility, there might be increased risk for serious intimate ethical boundary violations by session facilitators/monitors, including emotional, physical, and sexual abuse (Anderson, B., Danforth, A., Grob, C., 2020; Goldhill, 2020; Pilecki et al., 2021), though psychedelics and entactogens are by no means unique in this regard. Some populations might have a higher risk for adverse reactions from psychedelic or entactogenic drugs, such as people with a known history of serious cardiac conditions or serious mental conditions such as borderline personality disorder or bipolar disorder (Bender and Hellerstein, 2022; Bradberry et al., 2022; Leonard et al., 2018; Lim et al., 2012; Malcolm and Thomas, 2021).

Given the broad array of potential challenges with therapies that may use psychedelics (e.g., psilocybin) or entactogens (e.g., MDMA), compounded by an absence of consensus about how best to address these challenges, a proactive collaborative approach may be most effective, where a partnership of subject matter expertise can consolidate efforts and collectively work to address relevant issues (Belouin et al., 2022; Belouin and Henningfield, 2018; Xi et al., 2023). Best practices good, credentialling, et. Information Being Requested

This letter seeks broad input to address five major landscape domains that may contribute to developing real- world risk reduction and mitigation frameworks that protect public health and safety when considering implementing potential therapies that use a psychedelic or entactogenic drug substance in medically supervised and interpersonally supportive settings. These include: (1) service delivery, (2) promoting participant protections, (3) engagement of communities, (4) safeguarding equitable access, and (5) best practices for data standards. Service Delivery

What is the spectrum of interdisciplinary practitioners who will be held accountable as session facilitators/monitors for the potential use of these substances in medically supervised and interpersonally supportive settings?

Training considerations

What are the minimal training standards for integrated care delivery?

What curriculum is needed that best addresses variations in psychotherapy (e.g., how best to address a participant's vulnerability and manage psychedelic-related challenging experiences)?

Credentialing considerations

What are the relevant background education, qualifications, professional experiences, and potential examinations that might be considered for interdisciplinary credentialing?

Which disciplines may represent `service providers' (e.g., clinical practitioners, counselors, peer support)?

What might be appropriate supervision and practice hour requirements?

What types of guidance documents may be necessary for those who provide close supervision/monitoring of participants using psychedelics or entactogens? Promoting Participant Protections

Provide input on strategies that may be critical to protecting participants, including:

What strategies will be needed to ensure participant education, screening for medical or mental health conditions that may disqualify from participation, and informed consent prior to an individual participating in a therapy that may use a psychedelic or entactogenic drug substance?

What is needed to assess baseline pre-dose and adverse event monitoring post-dose (e.g., suicidal ideation or behavior, physiological reactions, psychological harm, substance misuse, and drug-drug interactions)?

What information is available or needed on how medically supervised and interpersonally supportive settings might incorporate substance misuse screening and prevention, risk mitigation, safety and ethical monitoring strategies that protect participants from potential ethical boundary violations from providers?

What components need to be developed to support ethical- vigilance reporting systems (e.g., state departments of consumer protection, professional societies, state licensing bodies, and law enforcement)?

What data might be collected that improves existing pharmacovigilance reporting systems?

How will these strategies complement existing patient protection regulations enforced by FDA that reduce risk for clinical trial participants as well as for users of approved and regulated products? Engagement of Communities

The PATH Caucus invites input to help identify best mechanisms/approaches that achieve engagement with diverse communities, including:

How might some indigenous people's use of psychedelics (e.g., ayahuasca, peyote) as sacraments in spiritual ceremonial or ritual healing practices, improve our understanding to protect public health and safety?

How might we ensure engagement with vulnerable populations disproportionately affected by mental health conditions, including people experiencing homelessness, racial/ethnic minorities, sexual and gender minorities, older adults, people living with disabilities and chronic health conditions, and individuals in the criminal justice system (Ortiz et al., 2022)?

Are there examples of best practices that facilitate provider (e.g., clinical practitioners, counselors, and peer support) engagement with vulnerable populations?

How do we effectively navigate societal stigma associated with psychedelic or entactogenic use?

How do we effectively educate healthcare, local crisis response systems, and law enforcement?

How do we best engage in comprehensive transparent community educational outreach? Safeguarding Equitable Access

What should be considered critical elements to the development of capabilities across the following domains or activities?

Reimbursements that ensure equitable access to services.

Healthcare economic impact analyses.

Types of medically supervised and interpersonally supportive therapy settings.

Collaboration on activities that may include input on prescribing, administering, and dispensing.

Manufacturing and distribution standards.

Supporting oversight of the available supply of substances.

Diversion control monitoring.

Information on how potential psychedelic and entactogenic medicinal use might fit within the medication use process and workflow of health care systems.

How should these activities be performed in a manner that complements and supports FDA's regulation of development, manufacturing, distribution, marketing and use of psychedelics? Best Practices for Data Standards

What types of data standards and repositories (e.g., Coordinated Registry Networks) may be created to collect data that continually informs best practices and vice versa?

How might current surveillance systems of regulated and unregulated settings be improved?

For example, Researched Abuse, Diversion and Addiction- Related Surveillance (RADARS), Monitoring the Future, National Survey on Drug Use and Health, and the Drug Abuse Warning Network, collect actionable data on psychedelic and entactogenic use; associated adverse events; prevalence of medical and non-medical use; frequency, dose, and use settings; and participant comorbidities, health concerns, long-term effects, as well as demographic characteristics.

Please email your input and feedback to PATH@mail.house.gov by close of business on February 28, 2025. Your responses to these questions are crucial, as they will directly inform Congress on how best to contribute to protecting public health and safety, acknowledging the complex nature of issues associated with these novel therapies that use psychedelic or entactogenic substances in medically supervised and interpersonally supportive settings. We aim to ensure the path we walk is illuminated for all Congressional members where they can make informed decisions on the relevant issues.

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