Two cancer patients and the Advanced Integrated Medical Science (AIMS) institute are suing the DEA over psilocybin use. Both cancer patients are in end-of-life care for their terminal illness and are asking the DEA to give them access to psilocybin for relief. However, the DEA, in a response to AIMS co-director Dr. Sunil Aggarwal’s denial of a research permit to legally give these patients psilocybin. 

Argument

The argument comes in the form of the right-to-try laws Congress and 41 states, including Washington state, have adopted. These rules give terminally ill patients the right-to-try (RTT) investigational medications not approved for general use. Typically, the FDA takes seven to ten years to receive full approval. Some terminally ill patients don’t have the time to wait for full approval. 

“It is entirely consistent with the purpose and language of the state and federal right-to-try laws to include any controlled substances that have completed Phase 1 trials, including Schedule I controlled substances,” said Washington Deputy Solicitor General Peter B. Gonick. He shared his oral argument for RTT before a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit. “It’s entirely inconsistent with the right-to-try laws to prevent patient access to these treatments.”

In 2017, Washington state unanimously approved RTT for terminally ill patients. This gives patients access to Schedule I substances that have passed the first phase of FDA approval. Psilocybin mushrooms and a select few other psychedelics have made it past the FDA’s first round of approval for PTSD, pain, anxiety, and depression.

Counterargument

The DEA’s attorney, Thomas Pulham, argued the whole case should be dismissed. According to the DEA, the court doesn’t have the jurisdiction to preside over the organization’s recommendations. Since AIMS only asked for a recommendation and did not submit an application, they only received a recommendation in response. If AIMS had submitted an application and the DEA rejected it, then the court could preside over the decision, explained Pulham. 

“DEA’s action is not subject to judicial review, because it neither reflects the consummation of a decision-making process nor results in any legal consequences,” Pulham said. “It was an informal response to a request for assistance from a member of a regulated community that did nothing more than provide the agency’s view on existing law.”

When asked about laws under the right-to-try law, the lawyer for DEA replied, “as the agency indicated in its letter, there’s no procedure available under the Right to Try Act, because the Right to Try Act does not provide the agency any authority to waive the requirements of the Controlled Substances Act.”

However, when Pulham ended his argument, the judges appeared to show skepticism. “Usually we don’t require a party to go and subject themselves to liability in order to appeal,” Judge Nelson explained. “It sounds like there might actually be some legal consequences here. I mean, it is prohibiting them from doing what they want to do, and it’s subjecting them to enforcement action if they were to go forward.”

Future

The patients and AIMS only wish for the DEA to clarify the rules surrounding RTT. They want to know if these patients can use psilocybin to help them before they pass away. As more information becomes available, we will update you with the latest.

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