“Because substances in Schedule I are deemed to have no accepted medical use in under the CSA [federal Controlled Substances Act], the law does not provide for any registration that would permit such drugs to be dispensed in the course of professional practice.”

-Drug Enforcement Administration (DEA)

The DEA filed the brief late last week in the U.S. Circuit Court of Appeals for the Ninth Circuit, in response to the latest legal challenge from Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute. Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care.

Right To Try Laws

The clinic contends that the Controlled Substances Act (CSA) must be interpreted to allow a legal pathway for terminally ill patients to access psilocybin under state and federal Right to Try (RTT) laws. These laws were specifically enacted to give patients with limited time the chance to try promising investigational medications that haven’t yet received full approval. Washington State adopted a right to try law in 2017, and then-President Donald Trump (R) signed the federal Right to Try Act the following year. Dozens of other states followed along with their own RTTs.

Despite repeated attempts, AIMS has been stonewalled by the DEA. The clinic has presented numerous proposals outlining ways to legally cultivate or acquire psilocybin for use under Right-to-Try laws, all to no avail. In their scathing opening brief earlier this year, AIMS highlighted the DEA’s concerning lack of engagement: “The agency has categorically rejected each request,” they wrote, “without ever addressing the substantial arguments Dr. Aggarwal has presented in support of them.” This raises serious questions about the DEA’s commitment to patient access and adherence to the intent of Right-to-Try laws.

“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT ,it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.”

-AIMS

The Dispute

The DEA attempts to downplay the reach of the Right-to-Try (RTT) Act, despite eight U.S. states and Washington D.C. siding with AIMS in their legal fight for psilocybin access. The agency claims the law doesn’t apply to controlled substances at all. This narrow interpretation directly contradicts the spirit of RTT, which aims to empower terminally ill patients. The DEA argues the law simply removes some FDA red tape for non-controlled investigational drugs.

The DEA contends Dr. Aggarwal would need to be a registered researcher conducting an approved project. DEA says they are matters handled by different federal agencies.

The DEA’s response to the AIMS lawsuit borders on disingenuous. They dismiss AIMS’s interpretation of the Right-to-Try (RTT) law as a “fundamental misunderstanding,” a harsh label for a legitimate legal argument. Their claim that allowing psilocybin access would somehow grant the DEA authority over Schedule I substances is a red herring. Terminally ill patients, AIMS argues, deserve the chance to try potentially life-saving treatments, regardless of arbitrary classifications. This lawsuit is about compassion and patient choice, not some grand attempt to rewrite drug scheduling.

Background

Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal RTT laws.

When the DEA rebuffed that request, Aggarwal sued. But in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.

The current Ninth Circuit cases stems from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for the regulatory waiver to obtain psilocybin.

DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions.

Aggarwal’s Case

Encouragingly, as Dr. Aggarwal’s case progresses, research continues to build a compelling case for psilocybin’s potential medical benefits. Late last year, Congress signaled its support by including funding in a defense bill for studies on the therapeutic use of psychedelics like psilocybin and MDMA, particularly for veterans. Additionally, a recent clinical trial published by the AMA found promising results, demonstrating psilocybin’s “strong and persistent antidepressant effects” in patients with bipolar II disorder. It showed no negative impact on mood stability or suicidal ideation. Further bolstering this evidence, a joint study from Johns Hopkins and Ohio State universities linked psilocybin use with long-term reductions in depression, anxiety, and alcohol dependence. Alongside positive changes in emotional regulation, spiritual well-being, and social connection.

In a promising development, Canada took steps in 2020 to expand access to psilocybin for therapeutic purposes. That year, the country’s health minister granted compassionate exemptions to four cancer patients. It allowed them to legally use psilocybin for end-of-life care. This marked a significant shift in policy. Later in 2020, Canada also introduced regulations enabling certain healthcare professionals to legally possess and administer psilocybin in specific contexts. (source)

For more info on Dr. Aggarwal’s and AIMS research, click here!

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