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…
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.