Congressional Caucus Seeks Input On Psychedelic Therapy To Inform Development Of Regulated Access Model

Bipartisan congressional lawmakers are seeking input from experts about how to best set up a regulatory framework for the therapeutic use of psychedelics such as psilocybin and MDMA.

Reps. Jack Bergman (R-MI) and Lous Correa (D-CA), founders of the Congressional Psychedelics Advancing Therapies (PATH) Caucus, released a request for information from the public last month.

The lawmakers said they’re seeking to better understand “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,” the request says.

Any member of the public with relevant information are invited to provide feedback to the caucus by November 5. The lawmakers specified their interest in hearing from people with experience receiving psychedelics-assisted therapy, people working in the “bio-psycho-social-spiritual behavioral health ecosystem” and stakeholders.

“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,” the request says.

They also stressed the value of getting input from members of indigenous communities that have incorporated the use of psychedelics in their practices, acknowledging 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,” Bergman and Correa said. “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 the Food and Drug Administration (FDA) approves psychedelic-based treatments, the lawmakers said it will be critical to understand the best methods of supporting states and federal agencies such as the U.S. Department of Veterans Affairs (VA) in building out risk mitigation practices and regulatory frameworks that ensure equitable access to the medicines and patient safety.

FDA has designated psilocybin, MDMA and an LSD-like drug as breakthrough therapies, recognizing their significant therapeutic potential. An FDA advisory panel took up an application to authorize MDMA-assisted therapy this year, but it was ultimately rejected, prompting pushback from advocates and bipartisan lawmakers.

Lawmakers separately staged an event at the U.S. Capitol in July calling for the MDMA approval by FDA and also launched an art installation memorializing military veterans who died by suicide.

“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,” the Bergman and Correa’s new request says.

The request for information is centered around five main pillars: 1) service delivery, 2) promoting participant protections, 3) engagement of communities, 4) safeguarding equitable access and 5) best practices for data standards.

For example, they’re soliciting input on training and credentialing people to provide psychedelic services, screening patients to mitigate mental health complications resulting for their use of such substances, how indigenous communities’ experience with psychedelics could inform regulations, potential therapeutic models and improving monitoring practices to collect data on both regulated and unregulated use of the drugs.

“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,” the notice says. “We aim to ensure the path we walk is illuminated for all Congressional members where they can make informed decisions on the relevant issues.”

Meanwhile, representatives of a number of federal agencies convened earlier this month to discuss new treatments for PTSD, including therapies involving psychedelics, MDMA, ketamine and other drugs. While the officials acknowledged the substances’ potential to help treat PTSD and underlying symptoms, they also emphasized the need for further research to ensure efficacy and patient safety.

The U.S. House of Representatives has also approved amendments to a large-scale spending bill that would authorize VA doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

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The Senate Appropriations Committee last month passed report language for appropriations legislation conveying concerns about restrictions on marijuana and psychedelics research imposed by current prohibition.

FDA also recently withdrew a request for White House permission to conduct a study about the risks of using kratom and psychedelics amid a “rapid resurgence” of public interest in the substances. Advocates are celebrating the news after criticizing the initial request as another example of FDA “bias” against harm reduction options.

A national nonprofit drug policy reform group is separately mounting a challenge to the Drug Enforcement Administration’s (DEA) proposal to ban two psychedelic substances. Experts say the new federal restriction would be detrimental to ongoing research initiatives.

In a recent interview with Marijuana Moment, Sen. John Hickenlooper (D-CO) touted the therapeutic potential of psychedelics, calling it “timely and appropriate” that states like Colorado are taking the lead on reforming laws around the substances after making history with marijuana legalization.

Read the congressional request for information on psychedelics therapy below: 

Congressional Progressive Caucus Fundraises Off Marijuana Decriminalization As Harris Maintains Cannabis Silence On Campaign Trail

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