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A long-running showdown between a doctor and the U.S. Drug Enforcement Administration that could affect the legal status of psychedelics is heating up.

The agency last week urged the Ninth Circuit Court of Appeal to block the physician’s efforts to use psilocybin to treat depression in terminally ill cancer patients, Law360 reported. The case centers on the scope and application of federal and state “Right-to-Try” laws, which allows the use of unapproved, investigational drugs for therapeutic purposes.

Dr. Sunil Aggarwal, co-founder of Seattle-based psychedelics research and treatment clinic, Advanced Integrative Medical Science Institute (AIMS), has repeatedly argued that the Right to Try Act grants him the authority to administer psilocybin to his patients.

However, in a new filing, the DEA maintained that the Right to Try Act only amends the Federal Food, Drug, and Cosmetic Act and does not impact the restrictions imposed by the CSA. The agency asserted that doctors who wish to dispense controlled substances must comply with both sets of regulations.

“The CSA and the FDCA (which the Right to Try Act amends) are separate regulatory schemes with separate requirements and restrictions,” the DEA wrote. “Nothing in the Right to Try Act changes that.”

Aggarwal, who has been engaged in litigation over this for a few years now, says that psilocybin has shown promise in treating major depression in clinical trials and should be accessible to terminally ill patients. However, the DEA has repeatedly rejected his proposals, stating in a 2022 denied petition that offering psilocybin to terminally ill patients would not be consistent with public health and safety.

The doctor also claimed that the DEA wants him to register as a researcher to obtain the drug, which goes against the law.

That led him to appeal to the Ninth Circuit on the grounds that the agency’s decisions were arbitrary and contradict public health interests and established legal precedents. In February, he argued that the DEA must explain how their decision aligns with the CSA and the agency’s own precedent, since the DEA has granted waivers for therapeutic use of other drugs, like cannabis for children.

The DEA doubled down on its position, arguing that Aggarwal has not provided adequate evidence to support his claims. The agency also contended that it could not fully evaluate Aggarwal’s proposal because he failed to provide the text or scope of the waiver he was seeking.

Psilocybin is currently classified as a Schedule I drug, meaning it has no accepted medical use. However, the drug has received “breakthrough therapy status” from the FDA twice and is currently in stage III clinical trials.

It remains unclear when the appellate court may issue a ruling on this case.

In a separate case, the Ninth Circuit ordered the DEA to clarify why psilocybin should remain a Schedule I substance after the agency rejected Aggarwal’s petition to move it to Schedule II, which is for drugs with accepted medical use but severe restrictions.

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The post DEA resists permitting psilocybin for terminal patients under ‘Right to Try’ appeared first on Green Market Report.

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Adam Jackson, KahliBuds, 420GrowLife