Advocacy groups ask court to overturn the denial of a petition to reschedule psilocybin


Advocates for rescheduling psilocybin on the federal list of controlled substances are calling on the federal Drug Enforcement Agency (DEA) to review the drug’s status as a Schedule I substance in response to public interest and new attitudes about the drug among other federal agencies. Rescheduling psilocybin mushrooms would enable researchers to conduct better studies of the drug and allow doctors to potentially prescribe it as medical therapy.

Rescheduling Attempt

Like cannabis and LSD, psilocybin mushrooms have been designated as a Schedule I drug according to the Controlled Substance Act (CSA). Under this law, illegal drugs are classified according to their abuse rate and level of acceptable medical use. A Schedule I drug is considered to have no medical benefits and a high potential for abuse. Drugs within this category are highly controlled, and private citizens are not allowed to use or possess them.

In September, DEA denied a petition to reschedule psilocybin as a Schedule II drug from Washington-based palliative care specialist Sunil Aggarwal. Under a Schedule II designation, a drug is considered to have a high potential for abuse and some potential for creating a dependence but also offer some medical benefits. This category includes drugs like cocaine, methamphetamine, methadone and Aderall.

Aggarwal, who also serves as co-director of the Advanced Integrative Medical Science (AIMS) Institute in Seattle, Wash., called on the DEA to reschedule psilocybin, arguing that the federal Food and Drug Administration (FDA) had already designated the drug as a “breakthrough therapy” for severe depression. This designation means that a federal agency has recognized the drug as having some medical use, and Aggarwal argued that it meant the drug could no longer occupy a place in the Schedule I designation.

The DEA denied the petition, noting in a letter that a prerequisite for transferring a substance from one schedule to another is that the FDA must explicitly determine that the drug has a currently accepted medical use.

“To date, the FDA has not articulated any accepted medical use for psilocybin in treatment,” wrote Assistant Administrator of the DEA’s Diversion Control Division Kristi O’Malley. The agency did not address the FDA’s “breakthrough therapy” designation.

The doctor also applied to receive a federal waiver to administer psilocybin mushrooms to terminally ill patients under the Right To Try (RTT) Act, but was denied by the DEA.

Former President Donald Trump signed RTT into law in 2018. It allows terminally ill patients to try experimental therapies when all other treatment options have been exhausted. Experimental drugs can be accessed through RTT if they have completed an FDA-approved Phase 1 clinical trial or are currently in an active clinical trial as part of an application for approval with the FDA.

The DEA denied Aggarwal’s request for an RTT waiver on the basis that the law makes exemptions under the Federal Food, Drug, and Cosmetic Act (FDCA), which is unrelated to the controlled substances list. Aggarwal argues that the CSA specifically bars the agency from interpreting the law in any way that would contradict the FDCA.

Doctor Seeks Reversal

Aggarwal recently asked the U.S. Court of Appeals for the Ninth Circuit to step in and force the DEA to vacate its denial of his petition due to its failure to address the FDA’s “breakthrough therapy” designation for psilocybin.

The rescheduling petition brief claims that the DEA’s denial was “not serious, nor was it how Congress imagined the agency would conduct itself upon receiving petitions presenting meaningful arguments and recent evidence that call into question the propriety of an extant scheduling placement.”

The suit also claims that if the DEA is correct in its assessment, then all rescheduling petitions would be “futile.”

The suit also calls for the court to force the DEA to request scientific and medical evaluations regarding the matter from the (HHS) secretary. “There is every reason to believe that the HHS would conclude, as it has in the past, that a Schedule II placement is justified for an unapproved substance under these exceptional circumstances,” states the suit.

Advocates Step In

Psilocybin advocate groups and experts are now pressing the court to support Aggarwal. Amicus briefs have been submitted to the court by groups like NORML, End of Life Washington, EvergreenHealth, A Sacred Passing, Pancreatic Cancer North America and the Global Wellness Institute.

NORML’s brief said that the DEA’s denial of the petition could leave terminally ill patients in a lurch without recourse. “When considering appeals from the denials of rescheduling petitions, this Court should consider the real-world effect that lengthy delays have on patients who have no other options available and wish to try breakthrough therapies, such as psilocybin or cannabis. These procedural delays of the past—which often amounted to years, if not decades—should not be countenanced going forward,” wrote the advocacy group.

A brief from End of Life Washington, EvergreenHealth, A Sacred Passing, Pancreatic Cancer North America and the Global Wellness Institute, and a number of researchers claimed that the agency’s refusal to consider rescheduling psilocybin creates a cycle that makes it impossible to research whether the drug is medically viable.

The DEA’s “obstinance is founded on an infinity loop of excuses: it cannot consider rescheduling psilocybin until FDA gives its approval, FDA cannot give its approval until extensive safety studies are conducted on psilocybin, and psilocybin’s current scheduling adds prohibitive time and cost to the required extensive studies,” wrote the group.

Reason for Hope and Veteran Mental Health Leadership Coalition’s brief urged the court to vacate the denial of the rescheduling petition in light of psilocybin’s potential for treating PTSD and depression. “Suicide is a national health problem; decreasing Veteran suicide by prioritizing medical research activities is a national priority; and psilocybin-assisted therapy is a promising suicide prevention treatment that has accepted medical use under severe restrictions,” it said.