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

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.