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…
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.