Politics
Federal Court Rejects Doctor’s Push To Force DEA To Send Psilocybin Rescheduling Petition To FDA
A federal appellate panel has denied a motion by lawyers for a Washington State doctor trying to reschedule psilocybin under the federal Controlled Substances Act (CSA). In an order this week, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected the doctor’s request for a rehearing of an earlier court decision that returned the matter to the Drug Enforcement Administration (DEA).
While the earlier ruling, in October, technically went against DEA, the court did not send the rescheduling petition to the Food and Drug Administration (FDA) for review, as lawyers for the doctor had requested.
Earlier this week, lawyers said in a petition for rehearing that they’re asking for the panel to revisit the ruling because the order “did not address” their argument that federal statute “requires a referral” to FDA to conduct a “scientific and medical evaluation and scheduling recommendation.”
Instead, the court ordered a remand back to DEA itself.
“This omission has both legal and practical ramifications for the Petitioners,” wrote lawyers for the doctor, Sunil Aggarwal, of the Advanced Integrative Medical Science (AIMS) Institute, “and Petitioners request that the panel correct this legal error.”
As lawyers for Aggarwal explained in their request for the rehearing, “In a civil case where one of the parties is a United States agency, any party may file a petition for re-hearing within 45 days, stating with particularity each point of law or fact that the petitioner believes the court has overlooked or misapprehended.”
“If agencies could simply procure naked remands (as the Court ordered here) in response to substantive petitions, such a precedent would embolden agencies to avoid making decisions on the merits,” the filing says. “In other words, such a precedent would incentivize agencies to say less, not more, in initial decisions, multiplying judicial workload and delaying decisions on the merits.”
But in a one-line ruling handed down on Tuesday, the court denied the rehearing request without explaining its reasoning.
Given that Aggarwal’s rescheduling petition is back in DEA’s hands, the agency could now reject the request again and keep psilocybin’s legal status unchanged. The doctor told Marijuana Moment in October, however, that “we have no way of saying that is what to expect.”
we have no way of saying that is what to expect
— Sunil KumarAggarwal (@humansunil) October 27, 2023
Aggarwal has been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care. He initially sought to win permission from regulators under state and federal right-to-try laws, which allow patients with terminal diseases to try investigational medications that haven’t been generally approved.
When DEA rebuffed that request, Aggarwal sued. But in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.
The current Ninth Circuit case stems from Aggarwal’s response to last year’s ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action.
DEA denied Aggarwal’s petition in September of last year, and Aggarwal filed suit in December.
In its October ruling, the Ninth Circuit panel said DEA’s denial “failed to provide sufficient analysis” and “failed to clearly indicate that it has considered the potential problem identified in the petition.”
“Given the inadequacy of the DEA’s denial letter,” the court wrote in a footnote, “we do not address Aggarwal’s statement that 21 U.S.C. § 811(b) requires the DEA to refer Aggarwal’s petition to the Department of Health and Human Services.”
As Aggarwal’s rescheduling effort has made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. And just this week, Congress sent a defense bill to President Joe Biden (D) that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.
Earlier this month, results of a clinical trial published by the American Medical Association found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder, “with no signal of worsening mood instability or increased suicidality.”
A separate study published this month, meanwhile, found that psilocybin—along with LSD—could offer promising therapeutic potential for the treatment of chronic pain “on a mechanistic and experiential level.” What’s more, authors of that analysis noted, the pain-relieving effects of LSD and psilocybin seem to increase with repeated treatment, unlike opioids, which display “decreased therapeutic effect” over time.
In September, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion.
Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”
In August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
And a survey by Canadian researchers published in October said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.”
A first-of-its-kind analysis released in June offered novel insights into the mechanisms through which psychedelic-assisted therapy appears to help people struggling with alcoholism.
At the federal level, the National Institute on Drug Abuse (NIDA) recently started soliciting proposals for a series of research initiatives meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.
The findings aren’t limited to psilocybin. For example, a peer-reviewed study published in the journal Nature recently found that treatment with MDMA reduced symptoms in patients with moderate to severe PTSD—results that position the substance for approval by FDA as soon as next year.
Read the Ninth Circuit ruling and Aggarwal’s full request for rehearing below:
FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD
