With the rejection of MAPS / Lykos’ FDA application for MDMA therapy at the federal level, it can feel like psychedelic progress is being blocked in Washington, and advocates should focus on the state level instead. But there are still promising signs of support for psychedelic medicines at the federal level. Indeed, the same day the FDA knocked back Lykos’ application (August 9th), Congress published a Request For Information asking the ‘psychedelic ecosystem’ to help them formulate best practices.
In this week’s deep dive, we’ll look at some of the psychedelic initiatives underway in the US federal government, and what big donors are getting behind.
Several psychedelic initiatives have been launched or will soon be launched on the Hill. They include:
Douglas ‘Mike’ Day Psychedelic Therapy to Save Lives Act
Who introduced it: Reps Crenshaw (R-TX) and Luttrell (R-TX). It was supported by psychedelic campaigners Apollo Pact, VETS, and possibly others
What did it do: Secured $10 million in psychedelic research funding by DoD and VA to treat active-duty service members with PTSD or Traumatic Brain Injury.
Status: Language signed into law as part of National Defense Authorization Act (NDAA) in December 2023
Breakthrough Therapies Act
Who introduced it: Senators Booker (D-NJ) and Paul (R-KY) and Reps. Dean (D-PA) and Mace (R-SC). Supported by Reason for Hope and the Veteran Mental Health Leadership Coalition, including Navy SEAL Foundation, Heroic Hearts Project, Grunt Style Foundation, Healing Breakthrough, BrainFutures, and around 40 other organizations.
What would it do: The Breakthrough Therapies Act would enable (but not guarantee) expedited rescheduling by DEA/HHS of Schedule I breakthrough therapies or expanded access drugs to Schedule II. This would accomplish two important goals: reducing barriers to research and enabling compassionate use under the federal Right to Try Act. The bill also includes a DEA requested safeguard: if a rescheduled investigational drug is placed on clinical hold, it could be expedited back to Schedule I.
Status: Yet to pass.
Right to Try Act and FDA Expanded Access Programme
Who introduced them: Senator Ron Johnson (R-WI) introduced the Right to Try Act in 2018, while the FDA Expanded Access Programme has existed since 1979
What do they do: The FDA Expanded Access (EA) programme was established to let patients with a life-threatening condition try an investigational drug before Phase 3 approval. The Right to Try Act was passed in 2018, similarly to allow end-of-life patients access to experimental treatments if they have passed a Phase I FDA trial. RTT was passed in large part as a response to the overly burdensome EA regulatory barriers. It’s similar to the Special Access Programme in Canada, under which hundreds of patients with life-threatening conditions have successfully applied to Health Canada to be granted access to psilocybin treatments.
Status: MAPS treated around 50 people with MDMA in 2020 through the FDA Expanded Access Programme but other psychedelic companies are wary of this programme because they think it prejudices the FDA against their approval applications. The RTT route has also faced challenges for psychedelic treatments - the DEA has been unwilling to allow a Schedule 1 substance to be accessed through RTT. There is currently a law suit between the DEA and the Advanced Integrative Medical Science Institute in Washington State over the right of the latter to offer end-of-life psychedelic treatments under the RTT Act.
VISIONS Act
Who introduced it: Reps Blumenauer (D-OR) and Garcia (D-CA) in September 2023
What would it do: If passed it would prohibit DoJ from spending funds prosecuting companies for state-legal psilocybin businesses, in the same way the Farr-Rohrbacher amendment protects state-legal cannabis businesses from federal prosecution.
Status: didn’t pass.
Psychedelic Caucus Request for Information
Who introduced it: Rep Bergman (R-MI) of the PATH Caucus
What did it do: The Psychedelic Advancing Therapies (PATH) Caucus was established in 2022, and in September 2024 put out an RFI calling for information from stakeholders regarding psychedelic safeguards. The information will be summarized by academic experts and put into the Congressional Record, and could then inform federal policy going forward. More on this initiative below.
Status: announced September 2024, deadline for submissions February 2025
Possible veterans access to psychedelic treatments bill
What would it do: We’ve heard from multiple sources that there is a desire in Congress and the Senate to support veterans to access psychedelic medicines without having to leave the country. It’s early discussions but this could take the form of legislation to enable veteran access to psychedelic medicine, perhaps through university-run trials that would be less burdensome than FDA clinical trials from a regulatory perspective but would still collect and analyse outcomes. The Hill clearly ‘wants to get something done to help veterans’, in the words of one DC insider - but it’s early days and it remains to be seen what legislation might emerge.
Status: Yet to be launched.
Language introduced to various other legislative bills regarding psychedelic therapies
Finally, several other appropriations bills passed this year included language on psychedelic treatments, calling for different federal agencies to spend money advancing the field. For example, the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bill includes this passage:
While the Senate Labor-HHS Appropriations Committee Bill included this paragraph encouraging the NIH to spend more next year:
The Committee recognizes the increased interest and need to study psychedelics, including MDMA, ketamine, and psilocybin, and their potential therapeutic effects. The Committee encourages NIH to expand its current research agenda across its Institutes and Centers, potentially by forming a cross-Institute research group, and to encourage psychedelic research at the NIH Clinical Center. The Committee also encourages NIH to work with FDA in developing and supporting public-private collaborations to advance all forms of psychedelic research for therapeutic purposes.
Then there are also some initiatives within the executive branch:
Veteran Affairs: A VA Integrated Project Team launched earlier this year via an internal ‘Psychedelic Charter.’ The VA also announced a request for applications for psychedelic research in January 2024 (limited to MDMA and psilocybin for mental health conditions). Funding decisions are expected this fall but the total amount to be awarded is uncertain.
SAMHSA: The Substance Abuse and Mental Health Services Administration is part of the Department of Health and Human Services (HHS), as is the Food and Drug Administration (FDA), National Institute of Health (NIH) and National Institute on Drug Abuse (NIDA). HHS has gone back and forth over its public support for and involvement with psychedelic treatments (more on this below). However, SAMHSA is now expanding its technical work to establish relationships in the ecosystem, gather information and data, organize and attend psychedelic research events, and develop a public health monitoring and communication strategy for psychedelics.
Food and Drug Administration: the FDA issued draft psychedelic clinical trial guidance in June 2023, which is yet to be finalized following extensive public comments.
Government Accountability Office: the GAO released a report concluding DEA should improve its religious exemptions petition process for churches providing psilocybin and other controlled substances.
DEA: this is where it gets a little more confrontational. There are various disputes between psychedelic activists and the DEA over issues like the Right to Try act or the Religious Freedom Restoration Act.
Thanks to Brett Waters at Reason for Hope for his help with gathering this information.
So that’s what’s going on. In other words, like all legislative and executive initiatives in the US Federal Government at the moment, things are going slowly, but there is clearly a desire to support psychedelic medicine on the Hill, particularly for veterans, and the encouragement is there, even if it’s hidden away on page 124 of a giant appropriations bill. The executive branch, particularly HHS, ‘knows psychedelics aren’t going away’ in the words of one HHS staffer, and wants to have a more comprehensive psychedelic strategy - but that requires leadership and political will from on high. In the meantime, let’s focus on the Psychedelic Caucus RFI and our ability to contribute to this federal effort.
The PATH Caucus RFI
Rep Jack Bergman of the PATH Caucus read out the RFI in Congress in September. You can read the text here. It begins:
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.
The RFI seeks info on five themes:
(1) service delivery
(2) promoting participant protections
(3) engagement of communities
(4) safeguarding equitable access
(5) best practices for data standards.
The deadline is February 28 2025. Anyone can submit a docket to PATH@mail.house.gov, and then a team of psychedelic academic scientists are tasked with summarizing this information and putting it into the Congressional Record. The hope is this will then be used to guide HHS, FDA and Veteran Affairs policies, SAMHSA risk reduction policies, Congressional budget decisions, federal and state regulatory frameworks, and so on.
The NGO Apollo Pact played a key role in putting this RFI out through the PATH Caucus. Apollo Pact was founded by Jon Kostas, who was cured of alcoholism in a psychedelic trial and then became an advocate for psychedelic treatments. His mother-in-law is the well-connected former Congresswoman Mimi Walters.
Jon tells me:
The RFI is a very positive sign. It shows that this is a formal, official request for information to get a wide variety of stakeholders to come together and give any input they may have. This could lead to policy changes, federal funding changes, regulators will want to shape the regulatory framework with this information. I think one of the goals is to have this ready before any potential FDA approval, because I think Australia basically legalised psychedelic therapy without any of the infrastructure in place.
Psychedelic philanthropist Carey Turnbull tells me:
I think it’s under-recognized right now what the RFI’s implication is. People can’t believe the federal government is attempting to facilitate rather than discourage research and approval for psychedelic medicine. And it’s the best way to get equitable access covered by insurance.
This RFI has a long history. From what I understand, HHS originally prepared a draft RFI starting in 2022, when it was preparing for the expected FDA approval of MDMA therapy and other psychedelic treatments, as well as responding to state legislation on psychedelics in Oregon and Colorado. At that point, the HHS was spear-heading an initiative to create an Inter-Agency Taskforce on psychedelics, with Assistant Secretary for Mental Health and Substance use Miriam Delphim-Rittman involved in this effort. The Assistant Secretary wrote in a letter to Congresswoman Madeleine Dean:
The Task Force may establish and oversee the functions of a public-private partnership that can broadly focus on addressing numerous complex issues associated with psychedelic (psilocybin) and entactogenic (MDMA) medicines but whose risks to public health may require harm reduction, risk mitigation, and safety monitoring. Collaboration across federal agencies with outside stakeholders will be the most effective way to ensure we are thoughtfully coordinating work on emerging substances such as MDMA and psilocybin.
The original HHS RFI went through multiple drafts, with input from over 100 stakeholders - including the FDA, SAMHSA, the DEA and DOJ, the Attorney-General, the White House and various lobby groups and interest groups. It was all ready to go but then - and this is just speculation although I have heard it from two sources - the White House got cold feet and stopped HHS from publishing the RFI and establishing the Psychedelic Task Force. This may have been after news of the Task Force was leaked to the press in July 2022, I honestly don’t know.
But somewhere along the way HHS and / or the White House pulled back - a sign perhaps of growing political nervousness around psychedelics in the run-up to the FDA decision on Lykos, also evidenced in state governors vetoing psychedelics legislation in California and Arizona in the last 12 months.
The HHS RFI then got picked up by the PATH Caucus and published this September. One source suggests it’s a way for HHS and FDA to gather information without taking any political heat from fronting the initiative themselves. Some people at PSFC question what the actual impact of the RFI will be. My answer (from a total outsider to US politics) would be it keeps the momentum going at the federal level, especially at HHS.
‘I think it’s under-recognized right now what the RFI’s implication is. People can’t believe the federal government is attempting to facilitate rather than discourage research and approval for psychedelic medicine’. - Carey Turnbull, psychedelic philanthropist and founder of BMore
Apollo Pact hasn’t got much financial support yet from psychedelic philanthropists. Instead, it’s now looking to psychedelic corporates for funding, and is about to launch a psychedelic trade association representing companies like Lykos, Compass, MindMed, Usona and BMore, along the lines of the Psychedelic Association of Canada. It has a scientific advisory board of (unpaid) advisors. The website (yet to launch) says the Association would
Serve as the trusted and recognized industry voice – at the national and state levels – on prescription psychedelic medicine and its integration into the healthcare system [and] demonstrate the importance of government-sponsored research, public-private partnerships, patient centricity, and healthcare infrastructure development to support the foundation of this innovative area of medicine.
Lukewarm PSFC support for federal lobbying?
It’s notable that Apollo Pact has turned to psychedelic corporates for support rather than the wealthy philanthropists of the Psychedelic Science Funders Collaborative (PSFC).
If you look at this excellent recent analysis by Psychedelic Alpha, what little psychedelic philanthropy money has been spent on federal lobbying has mainly gone to Healing Breakthrough and Reason to Hope to work on the Breakthrough Therapies Act (which hasn’t yet passed). Other NGOs active on the Hill, like the Psychedelic Medicine Coalition haven’t received any funding from PSFC members or, in the case of Apollo Pact, hardly any. Meanwhile, according to some estimates PSFC donors have spent $25-50 million on state initiatives.
Is the PSFC more focused on state initiatives than federal ones? Let’s have a closer link at this very influential yet little-discussed organisation and see what it’s evolving strategy is.
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