DEA Opposes Doctor’s Request to Use Psilocybin Under ‘Right to Try’ Laws

The U.S. Drug Enforcement Administration (DEA) is urging a federal appeals court to reject a doctor’s effort to treat terminally ill patients with psilocybin under the Right to Try Act, arguing that this law does not create exemptions from the federal Controlled Substances Act (CSA).

Dr. Sunil Aggarwal, co-founder of the Advanced Integrative Medical Science Institute in Seattle, has repeatedly sued the DEA seeking permission to use psilocybin to alleviate depression and anxiety in terminally ill patients. Dr. Aggarwal’s lawsuits are grounded in federal and state Right to Try laws, which allow patients with terminal conditions to use investigational drugs before these are officially approved by the Food and Drug Administration (FDA).

Psilocybin, the psychoactive component of magic mushrooms, has demonstrated significant potential in clinical trials for treating various mental health disorders, including depression, anxiety, PTSD, and substance abuse issues. Despite being designated as a “breakthrough therapy” by the FDA, psilocybin remains a Schedule I substance under the CSA, indicating it is classified as having no accepted medical use.

Washington state passed its Right to Try legislation in 2017, coinciding with the federal Right to Try Act signed by former President Donald Trump. Dr. Aggarwal contends that these laws authorize him to use psilocybin in treating terminally ill patients.

The DEA, however, has consistently denied Dr. Aggarwal’s requests to administer psilocybin. In rejecting a 2022 petition, the DEA cited concerns over public health and safety, arguing that using psychedelics for treatment could be detrimental. The DEA also insists that Dr. Aggarwal register as a researcher to use psilocybin, a stipulation he argues is not required under the Right to Try Act.

Dr. Aggarwal has appealed the DEA’s decision to the U.S. Ninth Circuit Court of Appeals, claiming the denial was arbitrary and contrary to public health and established legal precedent. He asserts that the DEA must reconcile its decision with the CSA and its own policies, noting that the agency has previously granted waivers for other Schedule I drugs, such as medical cannabis for pediatric patients.

In a recent court filing, the DEA maintained that the Right to Try Act amends the Federal Food, Drug, and Cosmetic Act (FDCA) but does not affect the CSA. The agency emphasized that physicians must comply with both the CSA and the FDCA.

“The CSA and the FDCA are separate regulatory frameworks with distinct requirements and restrictions,” the DEA stated, as reported by Green Market Report. “The Right to Try Act does not alter this separation.”

The DEA also argued that Dr. Aggarwal’s claims lack sufficient evidence and that his proposal to administer psilocybin was not detailed enough to justify a waiver.

Shawn Hauser, a partner at Vicente LLP, criticized the DEA’s stance, accusing the agency of misinterpreting the law and using delay tactics to prevent terminally ill patients from accessing potentially life-saving treatments.

“Federal Right to Try laws are intended to enable eligible terminally ill patients to use investigational drugs that have undergone clinical trials, including Schedule I substances like psilocybin,” Hauser stated in an email to High Times. “The law specifically allows for the use of unapproved investigational drugs by terminally ill patients.”

Hauser further argued that the DEA’s actions are an obstruction to providing patients with access to treatments that have shown to be safe and effective in clinical studies.