November 17, 2022

Correa Launches Bipartisan Congressional Caucus to Explore Psychedelic Research for Mental Health

Congressional Psychedelics Advancing Clinical Treatments "PACT" Caucus

Washington, D.C. - Today, Congressman Lou Correa (D-CA) and Congressman Jack Bergman (R-MI) announce the launch of the Congressional Psychedelics Advancing Clinical Treatments “PACT” Caucus. The Caucus will address ways to alleviate the national mental health crisis through psychedelic science and research.


“Having served our Nation as a member of the United States military and in Congress, I’ve seen the destruction post-traumatic stress disorder can cause on my fellow veterans and their families. Our job is to find solutions to these problems, and if psychedelic-assisted therapy can help treat or even fully cure someone of their PTSD, we need to take a closer look at these potential life-saving therapies,” said Congressman Bergman, co-chair of the PACT Caucus.


“Psychedelic-assisted therapies have shown incredible lasting potential to treat depression, substance use disorder, & PTSD. Further clinical research is necessary– we must learn more about what additional diseases and disorders these compounds can successfully treat, but we should also learn what they don’t work for,” said Congressman Correa, co-chair of the PACT Caucus. “If these treatments can save the lives of my constituents and fellow Americans, and are safe to receive in clinical settings, why would we not want to research them?”

The goal and purpose of the PACT Caucus is to promote rigorous and urgent clinical research into the efficacy of psychedelics in treating brain health conditions, in accordance with the law. Therefore, this caucus is not for advancement of psychedelics for other uses, including legalization for recreational use or decriminalization of the compounds.


“Despite the initial promising results, so much more research is needed to determine efficacy and durability of these findings, to better understand the psychotherapy needed to support psychedelic journeys and to identify who can safely benefit.  But to date, it has been difficult for investigators to properly vet these treatments because conducting the trials with Schedule I compounds involve so many hurdles,” said Rachel Yehuda, PhD, Director for the Center for Psychotherapy and Trauma Research and the Icahn School of Medicine at Mount Sinai.


"The potential of these therapies is life-saving. But the risks of doing this outside of a clinical setting without medical screening and supervision are dangerous, and that is why I am excited this caucus is focusing on the clinical applications and research of psychedelics, and not decriminalization or legalization for recreational use," said former U.S. Congresswoman and chair of psychedelic patient advocacy Apollo Pact, Mimi Walters.


Background & Need 


● According to the National Institute of Mental Health (NIMH), approximately 50 million Americans have any mental illness (AMI) at any given time, of which 13 million Americans have serious mental illness (SMI). These numbers have increased due to the COVID-19 pandemic, lockdowns, and economic hardship that followed


● Most Americans struggling with mental illness, including clinical depression and PTSD, take medication as primary treatment. Unfortunately, the majority of patients with these conditions do not receive adequate benefit from currently available medications. 


● Mental health continues to be a relentless challenge for Americans who serve, or have served, in our nation’s armed forces. Every day, 17 veterans take their own lives – a number that has remained stubbornly persistent despite existing pharmacological and psychotherapeutic treatments. 


● Research conducted at leading institutions and universities nationwide shows that in a medically controlled setting with expert screening and preparation, psychedelics can relieve anxiety, depression, PTSD, and substance use disorder. These trials show dramatic results. When used with medical screening and support, it could be more effective at treating some psychiatric disorders than existing treatments and without taking daily medication. A single treatment has improved symptoms for months, and even years. 


● The U.S. Food and Drug Administration granted breakthrough therapy designation to MDMA and psilocybin in 2017 and 2019, respectively. According to the FDA, "Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on clinically significant endpoints." Additionally, in September 2021, the Acting Director of National Drug Control Policy recommended reducing barriers to research using Schedule I substances. 


● Johns Hopkins University and New York University are advancing FDA-approved clinical trials using psychedelics to treat addictions and other mental disorders. The Icahn School of Medicine at Mount Sinai is conducting trials of psilocybin-assisted psychotherapy and MDMA-assisted psychotherapy in PTSD in conjunction with the James J. Peters Department of Veterans Affairs Medical Center. The Dana Farber Cancer Institute of Harvard Medical School is working on a clinical trial using psilocybin for hospice patients. Yale University is performing multiple trials assessing psilocybin for depression, headache disorders, and obsessive compulsive disorder (OCD). 


The PACT Caucus will:


● seek to increase awareness among members of Congress, their staff, and the media of evidence-based psychedelic science and research based on FDA-approved clinical trials psychedelic-assisted psychotherapy (PaT) 


● hold regular briefings on Capitol Hill to keep members of Congress and their staff informed of the latest psychedelic science and research news 


● support increased federal funding for psychedelic science, medicine, and R&D and champion other legislative policies and priorities of importance to the research and science community


● highlight priorities on behalf of interested members of Congress to external stakeholders and the Executive branch 


● convene bipartisan thought leaders to educate Congress on the evidence around the research and science 


The PACT Caucus will seek more funding for the NIH for clinical trials to accelerate research: 


● The Congressional PACT Caucus will advocate for adequate mental health spending by the National Institutes of Health (NIH) for PaT clinical trials to accelerate research. The goal is to generate enough safety and efficacy data from the clinical trials for FDA and DEA to make their decisions regarding PaT therapies. 


● NIH's budget increased to $3,911 million in FY 2022, compared to $2,174 million in FY 2013. 


● The Advanced Project Research Agency for Health (APRA-H) is embedded in NIH. APRA-H's mission is to "support transformative high-risk, high-reward research to drive biomedical and health breakthroughs—from molecular to societal—that would provide transformative solutions for all patients." Congress allocated APRA-H $1 billion in 2022.