Bipartisan Measure Targets Barriers to Psychedelic Therapies for Terminal Patients

WASHINGTON – A group of House and Senate lawmakers from both parties unveiled legislation to permit physicians to deliver Schedule I substances, including MDMA and psilocybin, to individuals grappling with terminal illnesses or severe mental health disorders.

The Freedom to Heal Act, sponsored by Senators Cory Booker (D-N.J.) and Rand Paul (R-Ky.) alongside Representatives Madeleine Dean (D-Pa.) and Nancy Mace (R-S.C.), would carve out an exemption in the Controlled Substances Act to align these treatments with the existing federal Right to Try framework.

Under the proposal, eligible patients [those who have exhausted standard FDA-approved options] could receive supervised administration of investigational therapies after a Phase 1 clinical trial demonstrates basic safety. The bill establishes a registration process overseen by the Drug Enforcement Administration (DEA), enabling doctors to provide care without risking federal penalties for handling prohibited drugs. States would retain the option to opt out, preserving local control over implementation.

This initiative arrives at a moment when federal regulators have acknowledged the therapeutic potential of psychedelics. The FDA has granted breakthrough therapy designation to MDMA for post-traumatic stress disorder (PTSD) and to psilocybin for treatment-resistant depression, signaling these compounds could offer marked improvements over conventional medications. Clinical data from Phase 2 trials back this up, showing reduced symptoms in participants with conditions like PTSD, often with fewer side effects than traditional antidepressants. Yet the Schedule I classification [meant to denote high abuse risk and no accepted medical value] has blocked practical application, forcing some patients, particularly veterans, to seek care overseas or forgo options altogether.

Supporters outside Congress highlighted the human stakes. Martin R. Steele, a retired Marine lieutenant general and president of the Veteran Mental Health Leadership Coalition, urged swift action: “It is clearly wrong and immoral that veterans are leaving the country they selflessly served to access potentially lifesaving treatments… Lives are on the line. Let’s act now.” Gary Hess, the coalition’s advocacy director and a combat veteran, shared his story of traveling abroad for MDMA-assisted therapy after being deemed too severe for U.S. trials. “Nobody should have to take such drastic measures,” he said, crediting the treatment with turning his life around.

Experts in the field also weighed in. Dr. Lynnette Averill, who leads psilocybin research for veterans at Baylor College of Medicine, described the exclusion of the most vulnerable from trials as a persistent flaw in the system. “We must do more to help those individuals with life-threatening conditions who are out of options,” she said. The bill, she added, restores the Right to Try‘s original intent without undermining ongoing studies.

This is not the first attempt by these lawmakers to bridge federal restrictions and patient needs. Earlier versions, dating back to 2022, proposed rescheduling breakthrough psychedelics outright or easing research hurdles. The current draft narrows the focus to compassionate use, sidestepping broader rescheduling debates that have stalled in committees. It also responds to real-world setbacks, such as the DEA’s rejection of a Washington state doctor’s bid to use psilocybin in palliative settings under Right to Try.

From a policy standpoint, the measure strikes a deliberate balance. It expands access while embedding safeguards like DEA vetting and physician accountability, addressing concerns over diversion or unregulated use. Analysts tracking drug reform see it as a low-risk entry point for Congress, especially with bipartisan backing in an otherwise divided session. If passed, it could accelerate data collection from real-world applications, informing future FDA decisions, much like state-level psilocybin programs in Oregon and Colorado have done for local economies and health outcomes.

Still, passage remains uncertain. With the lame-duck calendar crowded and the incoming administration signaling a conservative tilt on drug enforcement, advocates may need to build momentum through hearings or amendments to must-pass bills. The psychedelic sector, valued at over $4 billion globally and growing at 15% annually, watches closely. Streamlined access could spur investment in domestic production and training, though entrenched DEA priorities pose a counterweight.