Marijuana Moment: Doctors Could Legally Administer Schedule I Drugs Like MDMA And Psilocybin To Seriously Ill Patients Under New Bipartisan Bill In Congress

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Bipartisan House and Senate lawmakers have introduced a bill in Congress to allow doctors to administer Schedule I drugs such as certain psychedelics to patients with life-threatening conditions.

The “Freedom to Heal Act”—sponsored by Sens. Cory Booker (D-NJ) and Rand Paul (R-KY), as well as Reps. Madeleine Dean (D-PA) and Nancy Mace (R-SC)—aims to expand on the country’s “right to try” law.

The policy creates an exception within the Controlled Substances Act (CSA) that gives qualified patients access to potential therapies that haven’t yet been approved by the Food and Drug Administration (FDA).

The lawmakers noted that FDA has designated two psychedelics, MDMA and psilocybin, as breakthrough therapies for the treatment of serious mental health conditions. Yet the Drug Enforcement Administration (DEA) currently has no pathway to authorize physicians to administer the drugs despite the broader right to try policy, they said.

To address that, the new bill would amend current statute to allow DEA to register and authorize doctors to administer the novel therapeutics.

“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,” Booker said in a press release on Thursday.

“Thousands of Americans, many of them Veterans, are desperate for access to these therapies after exhausting all approved treatments in the United States,” he said. “The Freedom to Heal Act is critical legislation that will remove unnecessary barriers and give physicians a pathway to legally administer these potentially lifesaving treatments.”

All four bicameral lawmakers introduced a bill last session that similarly sought to leverage right to try laws to expand access to Schedule I drugs for severely ill patients, albeit with provisions differing from those in the current proposal. In 2022, Booker and Paul teamed up on an earlier version of the legislation. Mace, as well as then-Rep. Earl Blumenauer (D-OR), sponsored the House version that year.

“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,” Paul said on Thursday.

“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,” he said. “This is a practical reform that honors both patient autonomy and medical judgment.”

Dean, for her part, said, “As families across the country face the growing mental health and substance use disorder crises, we must expand their options for care.”

“Our bipartisan legislation reduces barriers for physicians to provide compassionate use of several innovative and potentially lifesaving treatments, including MDMA and psilocybin,” the congresswoman said. “Our loved ones, including our veterans who served and sacrificed, deserve to heal—Congress must work to make that recovery possible for more people.”

The bill represents a departure from what the lawmakers proposed in previous years. The prior versions would have created a procedure through which current Schedule I drugs that are deemed breakthrough therapies by FDA, or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA), could be transferred to a lower schedule that would make them easier to study and promote drug development.

Relatedly, a Washington State doctor has spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care. His clinic has presented DEA with multiple proposals to legally cultivate or otherwise obtain psilocybin to treat patients under right to try. The agency has denied them all.

“We believe Congress should act with urgency to pass the Freedom to Heal Act,” Martin R. Steele, president of the Veteran Mental Health Leadership Coalition (VMHLC), said. “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,” he said.

Photo courtesy of Dick Culbert.

The post Doctors Could Legally Administer Schedule I Drugs Like MDMA And Psilocybin To Seriously Ill Patients Under New Bipartisan Bill In Congress appeared first on Marijuana Moment.

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