Dave Hodes
There are a number of law firms building a list of clients in the psychedelics industry, in part because there are more issues percolating within the legal system about a federally illegal substance, and more companies exploring developments in this space.
Zuber Law Firm, Los Angeles; Husch Blackwell, St. Louis; Calyx Law, San Francisco; Clark Howell, Los Angeles; plus a handful of other firms outside of the U.S. are all diving deeper to sort out the legal entanglements of the psychedelics industry.
Lawyers with psychedelics practices are working on such issues as intellectual property rights—product patents—which is to be expected in a new industry of startups elbowing their way into relevance as they begin the expensive and long road from discovery into FDA approved drugs. But there are more issues about psychedelics cropping up fast and furiously that are drawing attention from these law firms.
One new landmark case in psychedelics involves the right to try (RTT) law, which officially became the law of the land in May 2018, after 41 states developed their own version. It creates a uniform system for terminal patients seeking access to investigational treatments.
RTT opens a new pathway for terminally ill patients who have exhausted their government-approved options and can’t get into a clinical trial to access treatments. But RTT only applies to treatments that have completed an FDA-approved Phase 1 clinical trial and remain under study in an active clinical trial. For example, if there are a Phase 2 or 3 clinical trials for medical cannabis as a treatment of an underlying terminal condition, it may qualify.
Psychedelics is another matter.
There are murky gray areas within RTT applied to psychedelics that are being challenged in court in one particular case.
Gary Smith, a cannabis-focused attorney at the Guidant Law Firm in Phoenix, and general counsel to the nation’s oldest multi-racial peyote church is also the author of Psychedelica Lex, one of the first books to examine the law of psychedelic substances to help law firms and other organizations navigate novel legal and policy issues in this emerging sector. Smith is also a member of the legalization and regulation committee of the Psychedelics Bar Association (PBA).
RTT and the case of Advanced Integrative Medical Science Institute (AIMS) v. the Drug Enforcement Administration (DEA) recently got on his radar.
In one of his recent podcasts, his guest was attorney Kathryn Tucker, one of the founding members of the PBA and special counsel at Emerge Law Group, where she co-chairs the firm’s Psychedelic Practice Group. She is also the lead attorney on the AIMS v. DEA case.
Tucker discussed the RTT case involving the review of a letter that she and Dr. Sunil Aggarwal, who is the co-director of the AIMS, sent to the Drug Enforcement Administration (DEA) to get advice and guidance on how Aggarwal could administer psilocybin to two terminally ill patients without incurring liability under the Controlled Substances Act (CSA). AIMS is an outpatient clinic and research institute in Seattle, Washington.
Arguments began on September 2, 2021, before a three-judge ninth circuit court of appeals panel on the lawsuit against the DEA that was filed in March. A decision by the DEA to dismiss the lawsuit was rendered on January 31, 2022.
The case marks the first time that a federal appellate court was asked to weigh in on the meaning of the provision governing the interrelation of DEA’s and FDA’s spheres of authority, according to one of the attorneys representing Aggarwal, Shane Pennington with Vicente Sederberg law firm.
Tucker wanted the DEA to consider “additional registration” pursuant to the RTT Act to obtain psilocybin for therapeutic use for terminally ill cancer patients.
The DEA responded with a letter identifying the available exemptions in the CSA which showed that the RTT Act did not create any additional exemptions. They then provided straightforward guidance about the interaction of the RTT Act and the CSA. Tucker wanted a judicial review of what the DEA said in their letter.
In their summary to dismiss, the judges said that they didn’t have the jurisdiction to review the DEA’s letter. “We then filed a request that the DEA give us a final decision, called a request for waiver, which is one tool in the DEA toolbox,” Tucker said during her blog interview. “It could have issued an exemption.”
They also filed a petition to reschedule psilocybin off CSA’s Schedule 1 to Schedule 2. “This moment is an auspicious and important moment for every activist who wants to see dying patients have the benefit of psilocybin therapy,” Tucker said, calling for a grassroots letter-writing campaign to lawmakers to take a more active role in the DEA’s obstruction to the RTT law, and why a duly enacted state and federal law is not being respected by the DEA. “This is a moment where citizen activism can and should come to the fore,” she said.
She said there has been a tremendous groundswell of organizational support to allow RTT laws to operate as intended. “We really need to reignite that broad support now,” she said.
There’s clearly more to come on this issue.
Five different advocates and think tank groups filed briefs in support of AIMS in the case on May 21, 2021, including a brief by law professors and bioethicists stating that the DEA erred in refusing the request to access psilocybin for relief of debilitating depression and/or anxiety, and the court should reverse the summary decision to dismiss.
“The criticisms some have lodged against RTT laws simply do not apply in the present situation, where a well-known, safe and effective drug will be given solely as palliative care to patients facing the end of their lives,” the brief stated.
The brief then cited three studies to back up the efficacy of psilocybin, adding that “these and other studies show that, in research spanning nearly 60 years, psilocybin has been shown to be safe, well-tolerated, and effective in reducing depression and anxiety, particularly in patients facing end of life.”
Then on January 18, 2022, seven members of Congress sent a joint letter to the DEA, citing the AIM v. DEA court case. “We strongly believe that our constituents suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment,” they wrote, adding that quick action was needed.
As clinical psychedelics trials move into Phase 3, and are subsequently OKed by the FDA within 2-4 years, will the DEA just let its obstruction to the RTT go on until then? That doesn’t help now in this case and any other similar cases, Tucker said. “Some of these patients who need help now will not be alive by then,” she said. “So now we see RTT laws thwarted to the detriment of dying patients.”
Stay tuned..
