Debra Borchardt
A Seattle doctor is not giving up when it comes to the rescheduling of psilocybin. While the focus on rescheduling cannabis is talked about constantly, psilocybin also faces the same dilemma of being a schedule one drug. Law360 reported that Seattle physician Dr. Sunil Aggarwal filed a petition on Dec. 11, nearly two months after a circuit panel remanded his request to change psilocybin’s status back to the DEA and ordered the agency to clarify why it believes the drug should remain a Schedule I substance.
Dr. Aggarwal is requesting a rehearing stating “The Order did not address Petitioners’ argument that 21 U.S.C. § 811(b) requires a referral to the Food and Drug Administration (“FDA”) for scientific and medical evaluation and scheduling recommendation, and instead ordered a remand to the Drug Enforcement Agency (“DEA”). This omission has both legal and practical ramifications for the Petitioners, and Petitioners request that the panel correct this legal error.”
Backstory
Aggarwal and his clinic, the Advanced Integrative Medical Science Institute (AIMS) filed the original petition with the DEA in February 2022. They argued that there was several pieces of evidence from clinical trials showing psilocybin’s efficacy in treating depression for patients in end-of-life care and urging the agency to move psilocybin to the less restrictive Schedule II category.
However, the agency rejected the petition with a two-paragraph denial letter in September 2022, asserting that since the FDA had not yet approved a psilocybin-based treatment, there was no basis for moving the drug into Schedule II.
Aggarwal pushed back saying that the DEA had not considered the evidence placed in front of it and had neglected its responsibility to consult the U.S. Department of Health and Human Services for a scientific and medical analysis of psilocybin’s potential uses and benefits. The petition went on to say that the failure to explicitly order the DEA to refer the rescheduling request to the FDA was out of step with precedential case law and public policy.
Furthermore, the petition noted that the FDA’s findings on scientific and medical matters bind the DEA, and if the Department of Health and Human Services (“HHS”) recommends that the DEA not subject a substance to control, the DEA “shall not control the drug or substance.” Only after the FDA’s binding, expert views on scientific and medical considerations are rendered may the DEA assess whether “substantial evidence” exists to warrant initiating a formal rulemaking process.
Finally, the petition summed it up stating:
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. 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. For this additional reason, the Court should have ordered a referral to the FDA, rather than a remand to DEA.
