Contributors: Samantha Dalmass and Erin Duffy
To learn more about Samantha and Erin, click here.
Millions of Americans suffer from some form of mental illness each year. Major depression is the most prevalent mental illness, affecting roughly ten percent of American adults. Concerns about mental health and substance abuse have grown year over year, and the COVID-19 pandemic has only made matters worse. One survey found that over 40 percent of adults in the U.S. reported symptoms of anxiety or major depressive disorder during the pandemic - a roughly 30 percent increase in prevalence from the same survey conducted in 2019.1 Mental illness is undeniably a public health crisis, and the treatment options currently available sometimes fall short or have side effects that are not well tolerated, particularly for conditions like schizophrenia or borderline personality disorder.
Psychedelics have been shown to be viable alternatives in treating depression, substance use disorders, post-traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), eating disorders, anxiety, and other mental illnesses. However, research on psychedelics has been incredibly limited for the better part of the last 50 years due to various regulatory and societal obstacles that are still very much at play. Some of the major obstacles include federal regulation of psychedelics by the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA), as well as regulation at the state level. Aside from regulatory constraints, there has long been a certain stigma associated with psychedelic drugs.
Modern research on psychedelics began in the 1870s and was actually openly accepted for nearly the next 100 years, until clinical trials and medical research were largely abandoned due to changes in public opinion and heightened regulations. Regulation of psychedelics in the United States started in the early 1960s with an amendment to the 1938 Food Drug and Cosmetics Act classifying psychedelics as unapproved, experimental drugs requiring FDA permission before being administered to research subjects. But research activities weren’t completely stifled until 1970 when Congress passed the Controlled Substances Act (CSA), under which LSD and other psychedelics, as well as cannabis, were classified as Schedule 1 controlled substances.2 Such substances are considered to have (1) no currently accepted medical use; (2) a lack of accepted safety for use under medical supervision; and (3) a high potential for abuse.3 As a legal matter, a Schedule 1 classification limits researchers’ ability to conduct clinical research and patients’ ability to access the substances for medical purposes.
Today, the DEA and FDA are responsible for federal regulation of psychedelics, primarily through the CSA and Food Drug and Cosmetics Act, which means that even if psychedelics were successfully rescheduled as Schedule II or III, they would still need to complete the FDA approval process before they could be marketed by pharmaceutical companies and prescribed by physicians. And we know from recent attempts to reschedule cannabis that rescheduling psychedelics will certainly be a challenge. In fact, rescheduling is incredibly rare. The DEA has only ever moved a substance from Schedule I to Schedule II five times, and it has only removed a Schedule I drug entirely from the list of scheduled substances on two occasions.4
However, both the FDA and DEA have recently acknowledged the growing body of evidence supporting the use of psychedelics for legitimate medical purposes, indicating attempts to reschedule may not be entirely in vain. Although no psychedelics are currently approved by the FDA for the treatment of any condition or disease, psilocybin, the psychedelic compound in “magic mushrooms,” has been granted breakthrough therapy designation for the treatment of major depressive disorder in two separate studies since 2018, which is designed to fast-track the development of a drug for serious or life-threatening conditions. The DEA has also just proposed a massive increase in cannabis and psilocybin production for medical research purposes, stating the proposed increase is “directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes.”5
Notwithstanding these recent developments, changes at the federal level will likely take time. But, as the medical marijuana industry has demonstrated, strict federal regulation need not stifle innovation altogether. Organizations interested in studying or administering psychedelics are still able to work within the existing regulatory framework by collaborating with the FDA and conducting well-controlled clinical trials to provide evidence and support for the safety and efficacy of psychedelics.6 Additionally, decriminalization efforts at the state level can be instrumental in promoting ongoing research and innovation. States have the option to take a hands-off approach to psychedelic regulation by removing state-level penalties for individuals who manufacture, possess, distribute, or consume psychedelics. Although individuals who engage in those activities in states where psychedelics are legalized can still be arrested by federal agents and tried in federal court, the federal government cannot compel the states to enforce federal drug law.7
Oregon was the first state to officially legalize psilocybin for therapeutic uses in November 2020 with the passage of Measure 109, also known as the Psilocybin Program Initiative. On that same day, voters in Washington D.C. passed a ballot initiative to decriminalize psilocybin and other natural hallucinogens. Since that time, a number of other states, including California, Maine, and Connecticut, have also proposed decriminalization legislation. Texas has also joined the list of states considering a more hands-off approach to psychedelic regulation. Because studies have shown psychedelics to be an effective treatment for PTSD, we may begin to see more traditionally conservative states join this list, as those who would usually oppose decriminalization efforts start to recognize the potential mental health benefits for veterans. In addition to state-level efforts, a number of cities across the U.S. have decriminalized psychedelics, including Oakland (CA), Santa Cruz (CA), Denver (CO), Cambridge (MA), Northampton (MA), Somerville (MA), Ann Arbor (MI), and Washtenaw County (MI).
It will likely be a few years at least before psychedelic therapy is widely available in the U.S. as a treatment option, but legalization efforts are gaining steam as is the body of research pointing to the potential health benefits of psilocybin and other psychedelic treatments. We will be keeping an eye out on ongoing state efforts as well as policy changes at the federal level.
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Disclaimer: This article has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice.
- Nirmita Panchal et al., The Implications of COVID-19 for Mental Health and Substance Use. KFF Issue Brief (February 2, 2021), https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.
- Controlled Substances –Alphabetical Order, https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf (last visited September 1, 2021).
- 21 U.S.C. §§ 801, 811(b)-(c), 812(b)(1); see also U.S. DRUG ENFORCEMENT ADMINISTRATION, DRUG SCHEDULING, http://www.dea.gov/druginfo/ds.shtml.
- See Scheduling Actions: Chronological Order, in U.S. DRUG ENFORCEMENT ADMINISTRATION, LISTS OF SCHEDULING ACTIONS, CONTROLLED SUBSTANCES, REGULATED CHEMICALS (2018), https://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf.
- Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021. 86 Fed. Reg. 49346 (September 2, 2021).
- Psychedelic Medicine for Mental Illness and Substance Use Disorders: Overcoming Social and Legal Obstacles, 21 NYU JOURNAL OF LEGISLATION AND PUBLIC POLICY 69 (2018), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3065035
- Id