Booker, Paul, Dean, Mace Introduce Bipartisan Legislation to Promote Access to Potential Life-Saving Drugs

WASHINGTON, D.C. - Today, U.S. Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced the Freedom to Heal Act, legislation that would create a narrow, DEA regulated system for physicians to administer Schedule I substances to patients with life-threatening conditions in accordance with the federal Right to Try law. U.S. Representatives Madeleine Dean (D-PA-04) and Nancy Mace (R-SC-01) introduced companion legislation in the House.

The federal Right to Try law permits patients who have been diagnosed with life-threatening diseases or conditions, and who have exhausted all approved treatment options, access to certain treatments that have not yet received final FDA approval. In general, a drug is eligible for Right to Try use after a Phase 1 clinical trial has been completed for that drug, but prior to the drug being approved or licensed by the FDA. Under the terms of the federal Right to Try law, states remain free to permit or prohibit Right to Try use under their own laws.

In recent years, two substances currently classified as Schedule I drugs-MDMA and psilocybin-have shown exceptional promise in treating a variety of mental health conditions, including treatment resistant depression and PTSD. In Phase 1 and 2 clinical trials, these drugs have been shown to be safe and effective-so effective that FDA has designated them "breakthrough therapies," meaning that they demonstrate substantial improvement over any currently available therapies. However, the DEA currently lacks a pathway under the Right to Try law to register and approve physicians to administer these potentially life-saving drugs.

The Freedom to Heal Act would create a Schedule I Right to Try physician registration process that would give people with severe, life-threatening conditions, including Veterans, a legal, supervised path to access these safe and effective therapies that have shown exceptional promise, while ensuring DEA oversight to prevent drug misuse or diversion.

"Patients facing life-threatening illnesses or severe mental health conditions deserve access to every possible treatment, including investigational therapies such as MDMA and psilocybin that have shown to be safe and effective in multiple clinical trials," said Senator Booker. "Thousands of Americans, many of them Veterans, are desperate for access to these therapies after exhausting all approved treatments in the United States. The Freedom to Heal Act is critical legislation that will remove unnecessary barriers and give physicians a pathway to legally administer these potentiallylifesaving treatments."

"As a physician, I have seen how critical Right to Try can be for patients who are running out of options. Yet current law leaves doctors with no clear, legal way to administer investigational therapies that fall under Schedule I. This bill creates that pathway. I am glad to work across the aisle to ensure patients, and their doctors are not blocked by federal barriers who have exhausted standard options. This is a practical reform that honors both patient autonomy and medical judgment," said Dr. Rand Paul.

"As families across the country face the growing mental health and substance use disorder crises, we must expand their options for care," Representative Dean said. "Our bipartisan legislation reduces barriers for physicians to provide compassionate use of several innovative and potentially lifesaving treatments, including MDMA and psilocybin. Our loved ones, including our veterans who served and sacrificed, deserve to heal - Congress must work to make that recovery possible for more people."

"Every American facing a life-threatening diagnosis deserves a fair chance at treatment. Our veterans and critically ill patients shouldn't have to travel abroad or break federal law to pursue care they need to survive. The Freedom to Heal Act removes the bureaucratic obstacles which stand in the way, ensuring eligible patients can finally access potentially lifesaving treatment right here at home." Representative Mace said.

"We believe Congress should act with urgency to pass the Freedom to Heal Act. It is clearly wrong and immoral that Veterans are leaving the country they selflessly served to access potentially lifesaving treatments that should already be available within our borders under Right to Try. Lives are on the line. Let's act now," said Martin R. Steele, Lieutenant General, USMC (Ret.), President of the Veteran Mental Health Leadership Coalition (VMHLC).

"I served during some of the heaviest levels of combat in Iraq and Afghanistan and came home with significant trauma. After a decade of talk therapy, surgeries, and pharmaceuticals, I was out of options-and was even denied access to an MDMA-assisted therapy trial because my condition was too severe. I ultimately had to leave the country to access psychedelic-assisted therapy, and it saved my life. While I was fortunate to have this experience, nobody should have to take such drastic measures. Yet there are thousands of other Veterans with similar experiences, including many of our coalition members. We're grateful to the leaders in Congress who are taking a stand with the introduction of the Freedom to Heal Act, seeking to put an end to this injustice," said Gary Hess, Director of Advocacy and Peer Support, VMHLC.

"As someone currently leading a clinical trial of psilocybin to treat Veterans with PTSD, I know firsthand the significant number reaching out for help but who don't qualify for our trial for various reasons. Unfortunately, it is often those most in need who are excluded. We must do more to help those individuals with life-threatening conditions who are out of options. The Freedom to Heal Act is a common-sense way to restore the intent of Right to Try and give patients a safe, legal path to pursue promising investigational therapies under medical supervision," said Dr. Lynnette Averill, Chief Science Officer, Reason for Hope, Associate Professor at Baylor College of Medicine, and Director of Research, The Menninger Clinic.

"As a palliative care physician, I've had many patients reach out seeking access to psilocybin for severe end of life distress, but regulation has stood in the way of the Right to Try. The Freedom to Heal Act offers a pragmatic legal fix that can meaningfully help relieve suffering for our patients in greatest need," said Drew Kotler, MD, Palliative Care, Main Line Health.

"As a coalition representing leading professional and patient organizations concerned with brain health, we recognize the need to balance additional research with access to promising treatments for those most in need. The Freedom to Heal Act will ensure the compassionate policy underlying Right to Try extends to some of our most promising investigational treatments for mental and neurological health conditions," said Katie Sale, Executive Director of the American Brain Coalition.

"It is hard to believe that federal law continues to block patients most in need - those with terminal or life-threatening conditions - from accessing our most promising investigational mental health treatments under Right to Try. The Freedom to Heal Act proposes a narrow, targeted solution to the Schedule 1 barrier, while ensuring DEA maintains its desired oversight. We thank the Congressmembers championing this issue, and hope Congress will work with the White House and DEA to quickly fix this obvious problem," said Brett Waters, Esq., Executive Director, Reason for Hope.

"Too many Veterans and patients with severe, life-threatening conditions must seek treatment abroad when options at home fall short. The Freedom to Heal Act helps close that gap. Sunstone supports this legislation because it delivers a safe, physician-guided path for those who have run out of alternatives. These patients deserve the very best of science, not additional obstacles to care," said Leith States, MD MPH MBA FACPM, SVP - Strategic Military Initiatives, Sunstone Therapies

"We absolutely must continue to fund and conduct rigorous research on these emerging therapies, which are showing real promise in treating serious mental health and neurological conditions. But we cannot ignore the fact that many patients who are desperately seeking relief do not meet inclusion criteria for existing studies. The Freedom to Heal Act offers a regulated pathway for these patients to access investigational treatments legally and safely while research continues," said Amy L. McGuire, JD, PhD, Leon Jaworski Professor of Biomedical Ethics, Director, Center for Medical Ethics and Health Policy, Baylor College of Medicine.

"The Freedom to Heal Act is important because it gives patients facing life-threatening illnesses the ability to pursue every possible option when time is running out-restoring autonomy, dignity, and hope at the moments when they need it most," said Sarah Norman, Executive Director, BrainFutures.

The Freedom to Heal Act is endorsed by: The Veteran Mental Health Leadership Coalition, Reason for Hope, The American Legion, American Brain Coalition, Iraq and Afghanistan Veterans of America (IAVA), Americans for Ibogaine, BrainFutures, Grunt Style Foundation, Irreverent Warriors, Veteran Research and Education Curation (VetREC), Wrestle Like A Girl, Texans for Greater Mental Health, Avesta Mental Health, Healing Breakthrough, Heroic Hearts Project, iXpressGenes, Inc., Mental Joe Apparel, The Menninger Clinic, Nevada Coalition for Psychedelic Medicines, Dr. Bronner's Magic Soaps, Mpower Counseling PLLC, Beckley Retreats PB, the Veterans Alliance for Holistic Alternatives, End it For Good, Marine Reconnaissance Foundation, Athletes for Care, The Mission Within, and Sunstone Therapies.

To read the full text of the bill, click here.