As the Oregon Health Authority moves forward with creating a program for the legal consumption of psilocybin following the enactment of Measure 109, other efforts to normalize the medical use of psilocybin continue. This week the Ninth Circuit ruled on a case concerning whether a physician may administer psilocybin without incurring liability under the Controlled Substances Act (“CSA”) in light of the Right to Try Act (“RTT ACT”), 21 U.S.C. § 360bbb-0a.
Unfortunately, the Ninth Circuit kicked the question. It held that it lacked jurisdiction to review the DEA’s response to a letter asking how the DEA would accommodate the RTT Act, because the response was not a “final agency decision of the Attorney General.” Thus, the court concluded that there was no “decision” to review.
The opinion is a deep dive into the workings of administrative law and judicial review of federal agency decisions. This post eschews a technical analysis of the decision in favor of what is hopefully a more approachable and useful commentary for physicians and others interested in using psilocybin for medical and therapeutic purposes.
What does the Right to Try mean in the context of psilocybin?
We’ve written about Right to Try before: “broadly speaking the RTT Act is a federal law enacted in 2018 to create a uniform system for terminal patients seeking access to investigational treatments.” Congress passed the RTT Act to give these patients access to investigational outside the clinical trial setting.
That last point—outside the clinical trial setting—is important. As the Ninth Circuit explained, usually “before a new drug can be introduced into the market, the FDA must approve its new drug application or biologics license application, which must include data from clinical trials.” Under this framework introducing psilocybin as a new drug means going through extensive clinical trials that include obtaining permission to test the drug on human subjects. If the application is approved the applicant must embark on three phases of clinical trials. That takes lots of time (and money). It’s also a byzantine process in the context of most Schedule I substances.
Because of these restrictions and difficulties of applying under a different FDA program (the “expanded access program”), Congress passed the RTT Act because some Americans need access to new drugs now. Notably the right-to-try movement has bipartisan support. See: “[A]new Republican-led bill in Missouri would expand that state’s existing right-to-try law to allow residents with serious illnesses access psychedelic drugs such as psilocybin, ibogaine and LSD.”
The RTT Act is not expressly directed toward psilocybin. Its main function is to relieve qualifying individuals from otherwise applicable regulatory requirements. So to be clear, the RTT Act is not a pathway for the recreational use of psilocybin and it is not the pathway under Oregon’s Measure 109 for the use of psilocybin. The RTT Act is a means to use new drug therapies (e.g. psilocybin or DMT) in certain circumstances without having to wait for completion of the full FDA clinical trial process.
Here, the Petitioner is a physician and co-director of the Advanced Integrative Medical Science Institute (“AMS”) in Seattle. He is registered with the DEA to prescribe controlled substances. He sought additional approval under the RTT Act to obtain psilocybin for “therapeutic use with terminally ill cancer patients suffering anxiety and/or depression.”
To us this seems like the perfect criteria for the right to try psilocybin.
Why did the petitioner seek a decision from the DEA on the right to try psilocybin?
In a few words: because of the failed war on drugs. Psilocybin is a Schedule I controlled substance under the CSA, meaning even microdosing is illegal. This means that potential criminal liability for the doctor, who wishes to use psilocybin therapeutically with terminally ill patients, and the patients themselves.
Underlying the immediate and serious risk of criminal prosecution is the larger goal in the psychedelic legal community of re- or de- scheduling psilocybin and forcing the DEA’s hand on its unreasonable, unfair (and frankly racist) scheduling of drugs and enforcement regime. To that end, the physician who brought this case to the Ninth Circuit just filed a petition with the DEA to reschedule psilocybin for medical use.
What does the Ninth Circuit’s ruling mean for the right to try psilocybin ?
In one sense the Ninth Circuit’s conclusion that it lacked jurisdiction does little. It does not address whether the DEA must accommodate the use of psilocybin under the RTT Act in its enforcement and rule-making with respect to the CSA. The court also did not decide that psilocybin cannot meet the criterion for use under the RTT Act. Nor did it adopt any substantive position in that respect advanced by the DEA. So one may argue it neither helps nor harms the law developing in this area.
In another sense, the lack of a substantive decision is exactly the problem. The DEA is adept at evading judicial review. (See here and here). And while the DEA makes procedural move after procedural move to avoid exposure on the merits of the War on Drugs — whether cannabis or otherwise — it continues its war on the American people. With Congress in an eternal deadlock on all things cannabis it seems unlikely the DEA is going to change unless and until forced by the courts. Let’s hope the new petition filed this week leads to a Court actually hearing evidence on the lack of merit in the DEA’s scheduling regime.