[Congressional Record Volume 170, Number 129 (Friday, August 9, 2024)]
[Extensions of Remarks]
[Pages E809-E810]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




    PROTECTING PUBLIC HEALTH AND SAFETY WITH PSYCHEDELICS ADVANCING 
                            THERAPIES (PATH)

                                 ______
                                 

                           HON. JACK BERGMAN

                              of michigan

                    in the house of representatives

                         Friday, August 9, 2024

  Mr. BERGMAN. Mr. Speaker, I rise today to include in the Record an 
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.

       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 
     naming 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.
       If 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) of 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 of MDMA, for example, should involve 
     thorough participant screening, education, and preparation, 
     supportive settings, and close supervision by

[[Page E810]]

     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 case 
     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 educations, 
     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 [email protected] 
     by close of business on November 5, 2024. 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.

                          ____________________