Alan Rockefeller at Wikimedia Commons

As terminally ill patients near the end of their lives, they often experience intense anxiety and fear. Some doctors say psilocybin mushrooms can help ease these negative feelings and make the transition much easier, but federal drug officials continue to stand in their way.

Now, a years-long legal battle with the Drug Enforcement Administration (DEA) over doctors’ rights to prescribe psilocybin mushrooms to terminally ill patients is making headway. A federal judge has ruled against the DEA, and it could change how magic mushrooms are treated in the U.S.

Dr. Sunil Aggarwal, a Seattle-based palliative care physician at the Advanced Integrative Medical Science Institute (AIMS), is appealing the DEA’s denial of his petition to reschedule psilocybin from Schedule I to Schedule II. The way psilocybin is currently classified as not having any medical use, with a high potential for abuse.

It can be difficult for researchers to navigate the regulatory hurdles blocking them from studying drugs categorized as Schedule I—like cannabis and LSD, along with magic mushrooms. As an end-of-life doctor, Aggarwal wants to give dying patients legal access to the drug by moving it to Schedule II, a categorization that would designate it as dangerous but useful in some medical instances. Drugs like methadone, oxycodone and fentanyl are included in this schedule, so shifting psilocybin to it wouldn’t exactly cause a stir on the street. But it would allow researchers to run clinical trials on the drug and potentially allow dying patients to gain access to it.

But the DEA took Aggarwal’s petition and threw it back at him. The agency’s only explanation for the rejection was that the doctor had failed to address a five-element test that determines whether a drug has a currently accepted medical use.

The five elements include whether the drug’s chemical makeup is known and reproducible, whether there are safety studies for the drug, whether there are studies proving efficacy, whether qualified experts have accepted the drug and whether the evidence is widely available.

During recent oral arguments before the U.S. Ninth Circuit Court of Appeals, Matt Zorn, an attorney on Aggarwal’s legal team, said the agency appeared to have ignored an extensive, peer-reviewed study that was attached to the petition addressing all five of the test’s elements.

“What is it that we are supposed to submit at this point to show that this has safety and efficacy evidence?” Zorn asked the judge. “This paper cites that in spades.”

Zorn suggested that the DEA rejected the petition because the legal team didn’t format its data along the lines of the five-element test. He said they didn’t do that because they are arguing that the five-element test is unlawful.

“All the other cases the agency is citing,” said Zorn. “None of those cases actually examined whether this test has any grounding in the text of the statute whatsoever.”

The lawsuit claimed that requiring the drug to have a “currently accepted medical use in treatment in the United States,” ignores the legal caveat that drugs with “currently accepted medical use with severe restrictions”—a description that fits psilocybin—are also allowed in the schedule.

Zorn argued that the five-element test exists so that the DEA can circumvent the law. 

“The reason it exists is very simple,” said Zorn. “[The] DEA wants to control the practice of medicine. That’s what’s going on here.”

The lawsuit argues that the petition should be passed on to the Department of Health and Human Services (HHS) and that allowing the DEA to reject petitions without the health agency’s input would make the HHS’s claim of superiority in matters of science and health meaningless.

Aggarwal’s fight with the DEA goes all the way back to a 2020 attempt to gain access to psilocybin for terminal patients under the Right To Try Act. The law, signed by former president Donald Trump in 2018, gave terminally ill patients the ability to try out experimental treatments that haven’t been fully approved by the Food and Drug Administration (FDA) as long as they’ve already tried more traditional treatments and are unable to participate in clinical trials.

The DEA denied Aggarwal’s request for a Right To Try waiver, and the doctor’s legal team filed suit in federal court. But that case was dismissed on a technicality. The doctor’s legal team then turned to petitioning the DEA to reschedule the drug. In September 2022, the DEA sent a letter to Aggarwal denying the petition, leading to the current lawsuit.

During the case’s oral arguments, U.S. Court of Appeals Judge Daniel Bress hammered Department of Justice (DOJ) lawyer Catherine Padhi on why the DEA believes it doesn’t need to send all drug-related petitions to the HHS. He also pointed out that the agency’s denial letter failed to specifically address the petition’s concerns.

Padhi stuck to the script and repeatedly asserted that the petition had failed to explain how psilocybin fit the criteria of the five-element test.

During his closing statement, Zorn told the judges that the victims of the DEA’s rejection are the patients nearing the end of their lives.

“The only difference between a Schedule I drug and a Schedule II drug that hasn’t been approved by the FDA—the delta between those two … is that doctors such as my client and other doctors can use that treatment in severely restricted expanded access for Right To Try scenarios to treat patients. That’s what [the] DEA is getting in the way of here.”

The court ruled in favor of Aggarwal last week, stating that DEA failed to define “currently accepted medical use with severe restrictions.” But the agency is not being forced to send the petition on to the HHS. Instead, the petition will return to the DEA. If the agency wishes to reject it again, it will be required to provide proof that it has considered the issues brought up by the petition.

The FDA has already approved magic mushrooms for Phase III clinical trials and has declared psilocybin a “breakthrough therapy.”