Psilocybin
Push For Psilocybin Rescheduling Amps Up
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,…
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 December 11th 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.
1776000-1776421-aims 12.11.23 rehearing petition
The post Push For Psilocybin Rescheduling Amps Up appeared first on Green Market Report.
psilocybin fda public policy-
Law & Regulation1 week ago
Tryp Therapeutics, Exopharm merger approved by shareholders
-
LSD1 week ago
The First Wave of Blotter Acid Inspired Trippy Psychedelic Art
-
Psilocybin7 days ago
Psychedelic Underground Celebrated in San Francisco on Bicycle Day Weekend
-
Psychedelics5 days ago
Compass Pathways and Journey Clinical Establish Research Collaboration Agreement To Inform the Training of Healthcare Providers and Delivery Model for COMP360 Psilocybin Treatment, If Approved for Treatment-Resistant Depression
-
Psychedelics5 days ago
Cybin to Participate at the 27th Annual Milken Institute Global Conference
-
Psychedelics4 days ago
Behold! A New Mushroom Emoji Has Arrived!
-
Psychedelics4 days ago
Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression
-
Psychedelics4 days ago
Behold! A New Mushroom Emoji Has Arrived!