A bipartisan group of lawmakers have filed a new bill in Congress what would require the Department of Defense to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military.
The Veterans and Servicemembers PTSD Emerging Treatment Review Act, filed this week by Rep. Abe Hamadeh (R-AZ), would direct the assistant secretary of defense for health affairs to coordinate with other federal officials to issue a report on how the results of study on psychedelic mushrooms that is currently being carried out in Arizona could “apply to members of the Armed Forces, including such members transitioning to civilian life.”
The report, due within 180 days of the legislation being enacted, would need to include “a summary of the safety, dosing, and adverse event data” from the research as well as “an assessment of the implications of such data for force health protection, medical readiness, and suicide prevention strategies.”
Officials would also need to describe “legal and regulatory requirements for any potential expanded access pathway involving an investigational Schedule I substance” and provide an assessment of the applicability of the federal Right to Try law and a psychedelics executive order signed by President Donald Trump for treating PTSD during post-deployment and transition periods.
The bill, which is cosponsored by Reps. Don Bacon (R-NE), Dan Crenshaw (R-TX) and Seth Moulton (D-MA), also contains a findings section that points out that existing PTSD therapies “are not effective for all patients.”
“Rigorous, ethical clinical research conducted in accordance with Federal law and force health protection standards is necessary to evaluate emerging treatments for service-connected mental health conditions where existing therapies have proven insufficient,” it says. “Private-sector innovators and public-private partnerships play a central role in developing, supplying, and evaluating federally lawful investigational products used in such clinical trials.”
The legislation also notes that psychedelic research underway in Arizona is “evaluating naturally derived, whole-mushroom psilocybin administered within a structured group-therapy setting for the treatment of post-traumatic stress disorder in veterans and first responders.”
Hamadeh said in a press release about the new bill that “our servicemembers and veterans deserve every opportunity to access the most effective treatments backed by rigorous scientific research.”
“Far too many Americans continue to struggle with treatment-resistant PTSD, contributing to suicide, substance abuse and challenges transitioning back to civilian life,” he said. “This legislation ensures Congress and the Department of Defense have the data needed to evaluate emerging research and make informed decisions that prioritize military readiness, force health and veteran care.”
Sue Sisley, the researcher overseeing the Arizona-based psilocybin investigation, said Hamadeh’s staff visited her facility and “saw firsthand what these FDA clinical trials mean for veterans and first responders, and what it could mean for transitioning servicemembers in the future.”
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Last week week, bipartisan congressional lawmakers filed a separate bill they say is intended to codify Trump’s psychedelics executive order into law.
Reps. Morgan Luttrell (R-TX), Lou Correa (D-CA), Jack Bergman (R-MI) and Michael McCaul (R-TX) introduced the Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy (IBOGAINE) Act on Tuesday.
The legislation would direct the attorney general to “take all necessary steps to determine whether to transfer ibogaine and ibogaine compounds” from schedule I to schedule II of the Controlled Substances Act (CSA) within 60 days. It also says that the attorney general and the health and human services secretary would need to initiate proceedings to reschedule any other Schedule I substances that complete Phase 3 clinical trials.
It would create a definition under federal law for ibogaine, to include “all parts of the plant Tabernanthe iboga” as well as any similar compound or analog that “acts on neuroplasticity, opioid receptors, or serotonergic pathways” that interrupt addiction cycles and restore neurological function disrupted by trauma, chronic substance use or traumatic brain injury.
It would further codify a national priority voucher program to support development of psychedelic and other therapies that can treat widespread maladies.
The legislation would additionally clarify that the federal Right to Try law provides exemptions from the CSA for seriously ill patients to access psychedelics and other Schedule I drugs in accordance with new special registration requirements it would create.
The Drug Enforcement Administration (DEA) would also have to revise its quotas for the amount of a controlled substance that can be legally produced if it is rescheduled, approved by the Food and Drug Administration (FDA) or designated as a breakthrough therapy.
The bill also creates a process for federal agencies to partner with states to “advance research on, and development of, psychedelic drugs, including ibogaine, for treating serious mental illnesses” as well as a framework for health agencies and the Department of Veterans Affairs (VA) to “collaborate with the private sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs.”
Luttrell and some of the cosponsors of the bill are also behind a proposed amendment to the National Defense Authorization Act that would extend a psychedelics research effort at the Department of Defense (DOD) for an additional six years. That proposal was cleared this week for floor action by the House Rules Committee.
Shortly after Trump signed the executive order, FDA and the Department of Health and Human Services (HHS) announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
Health and Human Services Secretary Robert F. Kennedy Jr. said recently that the Trump administration is “very anxious” to create a pathway for access to psychedelics therapy and that top officials across federal agencies want to “get it out to the public as quickly as possible.”
In an interview on the Joe Rogan Experience in February, Kennedy said he’s confident “we’re going to get it done,” with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a “very controlled setting.”
“Everybody in my agency…is very anxious to get a rule out there that will allow these kind of studies and will allow access under therapeutic settings, particularly [for] the military soldiers who have suffered these injuries to get access to these products,” the HHS secretary said. “We’re working through that process now. We’re all working on it and trying to make it happen.”
“I think that we’re going to get it done,” he said.
Last June, Kennedy said his agency is “absolutely committed” to expanding research on the benefits of psychedelic therapy and, alongside of the head of FDA, is aiming to provide legal access to such substances for military veterans “within 12 months.”
Veterans Affairs Secretary Doug Collins also disclosed in April that he had an “eye-opening” talk with Kennedy about the therapeutic potential of psychedelic medicine. And he said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for access.
Bipartisan congressional lawmakers introduced legislation this session to provide $30 million in funding annually to establish psychedelic-focused “centers for excellence” at U.S. Department of Veterans Affairs (VA) facilities, where veterans could receive novel treatment involving substances like psilocybin, MDMA and ibogaine.
A U.S. Senate committee held a hearing in April on a bipartisan bill to promote research into the therapeutic potential psychedelics by creating a new office at VA that would advance the development innovative treatments for serious mental health conditions and assist in reviewing the scheduling status of drugs like psilocybin, ibogaine and MDMA.
Read the full psilocybin bill below:
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