The Ninth Circuit Denies Petition to Allow Psilocybin Use Under the Right to Try Act
On February 13, 2025, the Ninth Circuit Court of Appeals issued a pivotal decision in Advanced Integrative Medical Science Institute, PLLC, et al. v. United States Drug Enforcement Administration. The court denied a petition for review, affirming the Drug Enforcement Administration’s (DEA) interpretation that the federal Right to Try Act (RTT Act) does not override the Controlled Substances Act (CSA) for Schedule I controlled substances, including psilocybin. This ruling has far-reaching implications for patients, healthcare providers and researchers navigating the complex intersection of investigational drug use and federal drug enforcement laws.
Background: The Right to Try Act and Schedule I Substances
Enacted in 2018, the Right to Try Act was designed to provide terminally ill patients with access to investigational drugs that have completed Phase 1 of FDA clinical trials but have not yet received full approval. The law allows eligible patients to bypass certain FDA regulatory requirements, enabling them to seek experimental treatments directly from manufacturers. The RTT Act was intended to offer hope and autonomy to individuals with life-threatening conditions when conventional treatments have proven ineffective.
However, the RTT Act does not explicitly address Schedule I controlled substances, which are regulated under the CSA. Schedule I substances—such as psilocybin, LSD and MDMA—are classified as having a high potential for abuse, no accepted medical use and a lack of accepted safety for use under medical supervision. The CSA imposes stringent regulatory requirements, including DEA registration and compliance with strict protocols, creating significant legal and administrative barriers to the use of these substances, even for research or medical purposes.
The Case: AIMS Institute’s Petition for Psilocybin Use
The Advanced Integrative Medical Science Institute (AIMS), a Washington State-based medical practice, sought to provide psilocybin therapy to terminally ill patients under the RTT Act. Psilocybin, the psychoactive compound found in “magic mushrooms,” has demonstrated significant promise in clinical studies for alleviating anxiety, depression, and existential distress in patients with terminal illnesses. AIMS argued that the RTT Act should permit the use of psilocybin without requiring compliance with the CSA’s registration and regulatory framework.
AIMS formally petitioned the DEA for an exemption, requesting that Dr. Sunil Aggarwal, the institute’s co-director, be allowed to administer psilocybin to terminally ill patients without obtaining a DEA registration. The DEA denied the request, asserting that the RTT Act does not supersede the CSA or provide a legal basis to exempt Schedule I substances from its stringent controls.
Following the DEA’s denial, AIMS appealed the decision to the Ninth Circuit, challenging the agency’s interpretation of the RTT Act and its refusal to grant an exemption.
The Ninth Circuit’s Decision
The Ninth Circuit upheld the DEA’s denial, concluding that the agency acted within its authority and that its interpretation of the RTT Act and CSA was reasonable. The court’s decision rested on several key findings:
Jurisdiction: The court confirmed its authority to review the DEA’s denial as a “final agency action” under 21 U.S.C. § 877, rejecting procedural challenges to its jurisdiction.
DEA's Reasoning Was Not Arbitrary or Capricious: The court held that the DEA’s decision was grounded in sound reasoning:
The DEA explained that the RTT Act does not modify the CSA’s requirements, which remain fully applicable to Schedule I substances.
Psilocybin, as a Schedule I drug, requires strict regulatory oversight to ensure compliance with public health and safety standards.
AIMS failed to provide sufficient specifics regarding how the exemption would operate within the framework of federal law, leaving the DEA without a legal or regulatory basis to approve the request.
Key Takeaways and Broader Implications
The Limits of the Right to Try Act
The Ninth Circuit’s decision clarifies that the RTT Act does not create a legal pathway for bypassing the CSA’s restrictions on Schedule I substances. While the RTT Act expands access to certain investigational drugs, it does not apply to substances classified under Schedule I, which are deemed to lack accepted medical use under federal law.Schedule I Regulations Prevail
The CSA’s Schedule I classification continues to pose substantial challenges for the use of substances like psilocybin, even in compassionate or investigational contexts. Any use of Schedule I drugs requires DEA registration and strict adherence to CSA protocols, regardless of the patient’s circumstances or the potential therapeutic benefits.Challenges for Medical Practitioners
This case underscores the regulatory hurdles faced by healthcare providers and researchers seeking to integrate Schedule I substances with demonstrated therapeutic potential into medical practice. Despite growing evidence supporting psilocybin’s efficacy in treating conditions such as anxiety, depression, and existential distress in terminally ill patients, its Schedule I status continues to restrict access. This leaves providers and patients reliant on legislative or policy changes to facilitate its use.
The Ninth Circuit’s decision may have broader implications for other Schedule I substances, including cannabis. If the court upholds such stringent interpretations for psilocybin, it signals that Schedule I restrictions will remain a significant hurdle for therapeutic applications of cannabis, particularly in states where these substances remain illegal.
The Ninth Circuit’s ruling highlights the complex interplay between federal drug laws and compassionate use initiatives like the Right to Try Act. While the RTT Act was designed to empower patients and healthcare providers, its limitations in the context of Schedule I substances reveal a gap in the law that may require future legislative attention. For now, healthcare providers and institutions must navigate these restrictions carefully, recognizing that the CSA’s requirements remain firmly in place.
As psilocybin and other psychedelics continue to gain attention for their therapeutic potential, this case serves as a critical touchstone for ongoing debates about drug policy, medical innovation, and patient rights. It also underscores the need for continued advocacy and legal reform to address the regulatory barriers hindering access to promising alternative medicines.
At Gies Law Firm, we remain at the forefront of this evolving landscape, providing expert legal guidance to clients navigating the regulatory challenges of emerging fields in alternative medicine. Our team is committed to staying abreast of developments in cannabis and psychedelic law, ensuring that our clients are well-informed and prepared to adapt to this dynamic legal environment.
