Controlled Substance Regulation for the COVID-19 Mental Health Crisis

72 Administrative Law Review 649 (2020).

70 Pages Posted: 26 May 2020 Last revised: 25 Feb 2021

See all articles by Mason Marks

Mason Marks

Florida State University - College of Law; Harvard Law School; Yale University - Information Society Project; Leiden University - Centre for Law and Digital Technologies

Date Written: May 21, 2020


The COVID-19 pandemic is producing widespread loss of life, unemployment, and social isolation that is triggering a mental health crisis. Experts warn there could be record levels of depression, suicide, and substance use disorders. The U.S. healthcare system is not prepared. It lacks the resources to provide prolonged psychotherapy at scale, and existing drug treatments are ineffective in about half the people who try them. Amid worsening mental health-related morbidity and mortality, the experimental drugs psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA) are an untapped resource. These drugs belong to a class of compounds called the psychedelics, which has been criminalized and stigmatized by the U.S. war on drugs for over fifty years. The U.S. Drug Enforcement Administration (DEA) classifies them as Schedule I controlled substances with a high potential for abuse and no currently accepted medical uses. However, recent clinical trials conducted in the United States and abroad undermine the DEA’s position and suggest that psilocybin and MDMA can safely treat a variety of mental health conditions. Moreover, unlike existing therapies, they act quickly, and their benefits are often sustained.

This Article explores the legal obstacles to administering psilocybin and MDMA to mitigate the COVID-19 mental health crisis. It surveys the scientific evidence for their use and outlines a path toward rapid deployment. Due to the urgent need for effective mental health treatments, the DEA should deschedule psilocybin, reschedule MDMA, and lift annual aggregate production quotas on these drugs. The Food and Drug Administration (FDA) should issue emergency use authorizations (EUAs) for their therapeutic use. To enhance safety, the FDA Commissioner can attach conditions of use to the EUAs, comparable to Risk Evaluation and Mitigation Strategies (REMS), such as requiring psilocybin and MDMA to be administered in controlled settings under professional supervision.

Prior to the onset of COVID-19, several cities decriminalized psychedelics while acknowledging their therapeutic benefits. The U.S. Department of Justice (DOJ), which enforces violations of the federal Controlled Substances Act (CSA), should pledge not to prosecute individuals who use psychedelics in accordance with state and local laws. Meanwhile, amid growing national scrutiny of law enforcement policies and procedures following high-profile police killings, Congress should reevaluate the DOJ’s prominent role in U.S. drug policy. It has come to light that the war on drugs rests on a foundation of misinformation and racial animus, which has devasted communities of color. Moreover, due to restrictions on research and development, the drug war adversely impacts people with mental health conditions by depriving them of effective drug therapies. Accordingly, Congress should amend the CSA to shift drug control from law enforcement agencies to science and public-health oriented agencies, such as the FDA and the National Institutes of Health. This restructuring of responsibilities would align federal controlled substance regulation with state drug control, which is overseen by public health agencies instead of law enforcement.

Keywords: psilocybin, MDMA, COVID-19, COVID, coronavirus, mental health, pandemic, psychiatry, FDA, DEA, drug policy, decriminalization, neuroscience, drug enforcement, psychedelics, cannabis, depression, anxiety, PTSD, post-traumatic stress disorder, SSRI, ecstasy, magic mushrooms, suicide, war on drugs

Suggested Citation

Marks, Mason, Controlled Substance Regulation for the COVID-19 Mental Health Crisis (May 21, 2020). 72 Administrative Law Review 649 (2020). , Available at SSRN:

Mason Marks (Contact Author)

Florida State University - College of Law ( email )

425 W. Jefferson Street
Tallahassee, FL 32306
United States

Harvard Law School ( email )

1563 Massachusetts Avenue
Cambridge, MA 02138
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Yale University - Information Society Project ( email )

P.O. Box 208215
New Haven, CT 06520-8215
United States

Leiden University - Centre for Law and Digital Technologies ( email )

P.O. Box 9520
2300 RA Leiden, NL-2300RA

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