Recent Developments in the Legal Landscape of Psychedelic Therapeutics
By Karen Luong, attorney with the law firm Husch Blackwell.
Psychedelic drugs like MDMA, psilocybin (“magic mushrooms”), LSD, and DMT have a fraught social and regulatory history in the United States. Their widespread use during the counterculture movement of the 1960s invoked harsh criticism and, ultimately, backlash from the government, earning these substances Schedule 1 designation as drugs that have “no currently accepted medical use.” But researchers have long argued that, quite to the contrary, psychedelics do have a significant beneficial use. Administered in a clinical setting with a trained therapist, they have the potential to treat some of the most traditionally drug-resistant mental health problems of our age, such as posttraumatic stress disorder (PTSD), addiction, and depression. Increased societal focus on the importance of mental health and wellbeing in recent years has led to a renaissance of scientific and commercial interest in psychedelics and their potential as valuable and effective therapies. Efforts are advancing across the United States to reschedule (from Schedule 1 to less-restrictive schedules), decriminalize, and (in some instances) legalize the use of psychedelics in a therapeutic setting. This article provides a brief overview of the regulatory framework restricting the production, sale and use of psychedelics; discusses psychedelic drugs which have been approved for limited use; and addresses recent legislative developments in the movement to decriminalize and/or legalize the use of psychedelics.
The Regulatory Framework for Psychedelics: A Brief Introduction
MDMA, psilocybin, LSD, Ibogaine, and DMT are designated as Schedule 1 substances under the Controlled Substances Act and are and remain illegal to produce, possess, distribute, or consume. This does not mean that progress toward legitimization is not happening.
The U.S. Drug Enforcement Agency’s (DEA) Diversion Control Division manages the registration of applicants seeking to study or otherwise handle Schedule 1 controlled substances for medical and scientific purposes, clinical research, and religious/indigenous use. A big issue with research of Schedule 1 drugs is that it can disqualify the facility—like a university—from receiving federal funding even for unrelated projects. Despite the fact that Schedule 1 drugs are defined under the Controlled Substances Act as having no accepted medical use, the DEA has recognized the importance of clinical research into the medicinal use of these drugs. In a 2018 press release promoting a new, streamlined application process for registration of Schedule 1 drugs, Acting DEA Administrator Robert W. Patterson stated: “Research is the bedrock of science, and we will—as we have for many years—continue to support and promote legitimate research with Schedule I controlled substances.” The DEA also regulates and enforces the importation of controlled substances and their precursors. In addition to DEA registration, most states have their own controlled substances laws that require pre-review and authorization or licensure for proposed research projects involving any Schedule I substances.
On May 19, 2021, Wake Network, Inc. announced the completion of the first legal psilocybin mushroom import into the United States. Wake had successfully applied for and received all required permits from the DEA to import psilocybin from its production facility in Jamaica to its laboratory in California for research purposes. According to Wake, “this is the only commercially produced, federally legal botanical psilocybin in the United States.” The fact that that DEA has permitted the import of psilocybin at all signals a marked departure from its previously strict stance—in 2007, the DEA used its discretion to block the importation of a generic version of the FDA-approved drug, Marinol (the manmade version of cannabis), based on the argument that its active ingredient, dronabinol, was a Schedule 1 substance. The DEA had assigned Marinol, but only the brand name drug Marinol, Schedule 3 status, while cannabis and its other forms remained Schedule 1.
Psychedelic Drug Development & FDA Review
The FDA has numerous, at times overlapping, programs to facilitate and expedite the development and review of new drugs and address unmet medical needs in the treatment of serious or life-threatening conditions. These programs include breakthrough therapy designation, fast track designation, accelerated approval and priority review. In addition, FDA has programs to facilitate the development of drugs that treat rare diseases (“orphan drug” status) and provide for expanded access, or compassionate use, of experimental drugs. Each of these designations carry their own requirements, and some overlap.
Breakthrough Therapy Designation, Expedited Programs and Clinical Trials Granted to Psychedelic Drugs
Breakthrough Therapy designation is one of the ways the FDA seeks to encourage and expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. Breakthrough Therapy designation confers a number of benefits, including eligibility for all Fast Track designation features, and guidance from senior managers at the FDA. Of all the drugs colloquially known as “psychedelics,” MDMA is the furthest along on the path to FDA approval, as it received the Breakthrough Therapy designation from the FDA in August 2017. The nonprofit organization Multidisciplinary Association for Psychedelic Studies (MAPS) is currently running Phase III clinical trials and is pushing to remove its Schedule 1 classification in 2023. The FDA also granted psilocybin Breakthrough Therapy status for research in October 2018 and again in 2019. Johnson & Johnson obtained the designation for ketamine (a Schedule 3 substance) in 2018, which paved the way for its patented drug, Esketamine, to obtain the designation in 2020. Other psychedelics that are currently undergoing research that have not yet been granted Breakthrough Therapy status include LSD, Ibogaine, and DMT, and it will be interesting to see whether research results eventually support these substances’ inclusion.
The FDA encourages the development of drugs for rare disorders (where the economic carrot of huge profits from sales does not exist) by offering “orphan drug” status, which carries various benefits including fee waivers, tax incentives, and a seven-year marketing exclusivity period. In April 2021, the FDA granted DMT orphan drug designation to PharmaDrug prior to preclinical trials for preventing ischemia-reperfusion injury in patients undergoing solid organ transplantation.
Compassionate Use
In certain situations, the FDA allows companies to provide their experimental drugs to people outside of clinical trials. This is referred to as compassionate use or expanded access. Getting access to not-yet-approved drugs through a compassionate use request is a complex process. In late 2019, the FDA agreed to an expanded access program for MDMA for clinical use to treat PTSD, to be run by MAPS under an approved protocol.
State and Federal Right-to-Try Legislation
The federal Right to Try Act, signed into law in 2018, allows patients with serious or immediately life-threatening diseases or conditions who are unable to participate in clinical trials to access certain unapproved treatments. Before this federal law, 41 states including California, Florida, Colorado, and Pennsylvania already had state right-to-try laws in place.
Eligible investigational drugs under the Right to Try Act must meet certain criteria defined by the FDA, and patients must meet certain criteria to seek Right to Try use; however, the FDA does not review or approve requests for Right to Try Act use—its role is limited to receipt and posting of certain information. Since reporting requirements have yet to be standardized, the FDA currently does not report, and we do not know, what drugs or how many patients have applied and received approval under this program.
The intersection of the Controlled Substances Act, the federal Right to Try Act, and state right-to-try laws is currently being tested in a case before the 9th Circuit, AIMS v. DEA. In this case, a group of physicians in Washington state seeking to administer palliative psilocybin therapy to their terminally ill patients to treat end-of-life anxiety approached the DEA for a determination as to whether this was allowable. The DEA stated that there could be no access to this Schedule 1 substance other than for research, and thus the therapeutic use by the physicians would not be allowed. The physicians petitioned the 9th Circuit via a direct review provision, and the case is currently working its way through the court in an expedited process. The briefing is ongoing and has already raised thought-provoking arguments addressing the right of people with terminal illness to choose palliative measures to ease the trauma and anxiety of their imminent deaths. Petitioners also argue that this is a states’ right issue and that the federal government’s nullification of state law is impermissible and violates long-standing principles of federalism. Amicus briefs filed in support of the petitioners include a bipartisan group of attorneys general from eight U.S. states, the American Civil Liberties Union, and leading policy and advocacy groups on both sides of the political spectrum.
Decriminalization and Legalization
Decriminalization is the decision of a governing authority to not enforce criminal laws relating to the use and possession of drugs such as psychedelics. Legalization would allow for regulation and taxation of drugs, and permission for personal use within parameters set by the government.
Proponents of decriminalization argue that the War on Drugs has had the opposite effect of its stated intent—criminalization has not deterred drug use, has made it less safe, and has created an unregulated underground market that leads to dangerous drug use-related deaths and violence resulting from gang and cartel activity. They argue that if the end goal is to lead to a more productive society, individuals with substance-abuse problems are much more likely to find recovery in rehab than if they have been incarcerated—and conversely, if an individual has a criminal record they are more prone to recidivism as they carry the stigma of being a convict throughout their lives. Supporters further argue that the War on Drugs has disproportionately affected minority and indigenous communities and has been used as an excuse for oppression via discriminatory policies and inconsistent enforcement. Countries around the world, including Portugal, the Czech Republic and Spain have decriminalized personal use of all substances.
Movements to decriminalize psychedelics and other drugs in the U.S. have been underway for decades, but the last three years have seen significant movement in the passing of legislation. In May 2019, Denver, Colorado, became the first city in the U.S. to decriminalize psilocybin. Similar legislation has passed, both for psilocybin and other entheogenic substances, in Oregon (statewide); Oakland and Santa Cruz, California; Washtenaw County, Michigan; Somerville, Massachusetts; Cambridge Massachusetts; Washington DC; and Northampton, Massachusetts.
Oregon’s Measure 110 passed in 2020 with a 58 percent vote of the state population and decriminalized the personal possession of all drugs. In June 2021, SB 519, a California bill to decriminalize the possession or sharing of psychedelic drugs, passed all three committees of the state Senate in June 2021, and will head to the Assembly.
On a statewide level, legislation is currently being proposed to decriminalize or otherwise ease restrictions on some psychedelics in a growing list of states. Bills are currently active in Hawaii, Iowa, Kansas, Massachusetts, Maine, New Jersey, New York, Rhode Island, Texas, and Vermont, and more states no doubt will follow.
Oregon was also the first state to legalize psilocybin therapy in 2020. Ballot measure 109 passed with a 56 percent vote of the state population and will establish a regulated psilocybin therapy system in Oregon to provide people therapeutic access to psilocybin.
It is impossible to discuss the legalization of psychedelics without drawing parallels to the movement to legalize cannabis; however, the two movements are quite different in their approaches. Unlike the legislation surrounding the decriminalization and legalization of cannabis, the proposed laws on psychedelics do not require individual patients / users to register with a provider or obtain a license (as in the case of medical marijuana licenses). Instead, the burden and responsibility for obtaining the proper licenses and registering with the state falls on providers of psychedelic therapies, such as physicians or clinics seeking to provide the substances for patients. The focus on regulating the providers, not the users, makes enforcement and tracking easier for authorities and reflects the more clinical and therapy-based approach taken by proponents of psychedelics.
Potency and reality-altering properties of some psychedelic substances may be why the current proposed legislation has largely avoided seeking legalization on a recreational level. Microdosing is an increasingly popular practice in the use of psychedelics like psilocybin and LSD—extremely low doses that are too small to produce perceptible effects, but that proponents claim may nonetheless offer a variety of benefits. It remains to be seen whether legislators will eventually push for the legalization of microdoses in a less-regulated setting or without the need for a licensed provider.
Legalization of psychedelics is, as of now, a state-level effort in conflict with federal law. Thus, legislative changes that have been taken place at the state level do not change the fact that these substances remain federally illegal. The interplay between states’ movements to legalize psychedelics for certain uses and the federal government’s control over the same drugs will eventually come to a head. Some policymakers have suggested that the federal government adopt the equivalent of the Cole Memorandum for psychedelics. The Cole Memorandum was a U.S. Department of Justice memorandum issued in 2013 (and repealed in 2018), that instructed state attorneys general to not enforce federal marijuana prohibition in states that had legalized marijuana. The purpose was to not waste already scarce federal resources on enforcing laws where states had determined marijuana would be allowed and where the states had established strong regulatory and enforcement mechanisms to enforce those laws. The same argument has been made that state laws legalizing psychedelics should receive similar treatment.
Equity, Inclusion, and Preservation of Indigenous Tradition
Legislative efforts to decriminalize and legalize psychedelic therapeutics have rightly taken into account the traditional use of these substances by indigenous communities. Ayahuasca, mescaline, peyote, and psilocybin, to name a few, have been used for hundreds of years in indigenous ceremonies, and there is growing awareness of the possible effects of legalization. For example, SB519 in California intentionally leaves peyote out of the substances it seeks to legalize, “because of the nearly endangered status of the peyote plant and the special significance peyote holds in Native American spirituality.” The American Indian Religious Freedom Act of 1978 (amended in 1994), codified at 42 USC 1996-1996a, protects American Indians from penalty, prosecution, or discrimination in public assistance programs from the sacramental use, possession, or transportation of peyote. Ongoing legislative and policy efforts to decriminalize and legalize psychedelics will likely continue to protect their sacramental use by indigenous populations.
Conclusion
The landscape is changing fast around psychedelic drug development, legislation, and research. There are a dizzying number of moving parts to the puzzle, and what holds true today may change tomorrow. As the movement to legitimize and psychedelic therapy progresses, one thing is certain: we are entering uncharted waters, and what a trip it will be.
Karen Luong, attorney with the law firm Husch Blackwell
Editor’s Note
This piece is part of a series produced by guest contributors to expand the voices on our site and in the greater conversation. While Microdose supports the education and exploration of these topics, the facts and opinions presented in this work are the author’s alone.