The Project on Psychedelics Law and Regulation (POPLAR)
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is engaged in a three-year initiative to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics. Launched in summer 2021 with a generous grant from the Saisei Foundation, the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.
Background
Despite a longstanding prohibition on psychedelics dating back to the 1970s, scientific and public interest in these substances is growing. Clinical trials repeatedly demonstrate their promise for treating mood, anxiety, and substance use disorders.
In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency identified psilocybin as a breakthrough for treatment-resistant depression. These developments indicate that psychedelics may represent substantial improvements over existing treatments for mental illness.
While psychedelic therapies make their way through the drug development pipeline, seven U.S. cities and the State of Oregon have decriminalized them, and last November, Oregon voters legalized the supervised administration of psilocybin. At least eight other states are considering similar legislation to legalize or decriminalize psychedelics.
Due to their therapeutic and commercial potential, the U.S. market for psychedelics is projected to reach $6.85 billion by 2027, attracting a significant number of for-profit companies and investors. However, despite the proliferation of clinical research centers, increasing private investment in psychedelic drug development, and widespread state and local decriminalization, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.
POPLAR is the first academic initiative focused on psychedelics law and policy, positioned to be a global leader for research and education in this space.
The Project
POPLAR will focus on promoting safety, innovation, and equity in psychedelics research, commerce, and therapeutics.
Project research will focus on the following key areas:
- Ethics in Psychedelics Research and Therapeutics
- Challenges at the Intersection of Psychedelics and Intellectual Property Law
- Opportunities for Federal Support of Psychedelics Research
- Access to Psychedelic Therapies and Equity in Emerging Psychedelics Industries
- The Role of Psychedelics in Healing Trauma
The POPLAR team will address these issues by publishing academic research; hosting academic events and roundtables with experts from industry, government, and academia; educating courts, legislators, government agencies, and the public; partnering with clinical researchers to help them navigate legal and ethical roadblocks in their work; and training the next generation of thought leaders in this emerging field.
Publications
Mason Marks, State-Regulated Psychedelics on a Collision Course With FDA, 330 JAMA 2337 (2023).
Mason Marks, Brent Kious, Carmel Shachar & I. Glenn Cohen, Introducing psychedelics to end-of-life mental healthcare, 1 Nature Mental Health 920 (2023).
Mason Marks & I. Glenn Cohen, How Should the FDA Evaluate Psychedelic Medicine?, 389 New England Journal of Medicine 1733 (2023).
Mason Marks, Cognitive Content Moderation: Freedom of Thought and the First Amendment Right to Receive Subconscious Information, 76 Florida Law Review (forthcoming 2024).
Mason Marks, I. Glenn Cohen, Jonathan Perez-Reyzin & David Angelatos, Microdosing Psychedelics Under Local, State, and Federal Law, 103 Boston University Law Review 573 (2023).
Mason Marks & Carmel Shachar, Drug scheduling limits access to essential medicines and should be reformed, 29 Nature Medicine 294 (2023).
Mason Marks, The Varieties of Psychedelic Law, 226 Neuropharmacology 109399 (2023).
I. Glenn Cohen & Mason Marks, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, Harvard Law Review Forum (2022).
Mason Marks, Automating FDA Regulation, 71 Duke Law Journal 1207 (2022).
Jonathan Perez-Reyzin, Leslie Booher & Ismail L. Ali, Revisiting the Drug Conversion Tables and Their Treatment of MDMA, 35 Federal Sentencing Reporter 24 (2022).
Mason Marks & I. Glenn Cohen, Psychedelic Therapies: A Roadmap for Wider Acceptance and Utilization, 27 Nature Medicine 1669 (2021).
Mason Marks, Legalization of Psychedelic Substances, 326 JAMA 2433 (2021).
Commentary by POPLAR Researchers
Mason Marks, Seeking Psychedelics? Check the Data Privacy Clause, WIRED (November 2, 2022).
Jonathan Perez-Reyzin & Ismail Lourido Ali, Considering Complexities with Measure 109 Implementation, Maps Bulletin Vol. 32 No. 2 (November 2, 2022).
Mason Marks, Warning: Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Therapy, Chacruna (December 14, 2021).
Mason Marks, A Strategy for Rescheduling Psilocybin, Scientific American Opinion (October 11, 2021).
Mason Marks, Proposed kratom ban will harm public and FDA credibility, STAT First Opinion (August 23, 2021).
Mason Marks, Inside the Fight to Legalize Psilocybin Therapy in Oregon, Gizmodo (October 22, 2020).
Mason Marks, Why D.C. and Oregon Should Vote Yes on Psychedelics, Slate (October 19, 2020).
For other commentary by Mason Marks, see Psychedelic Week.
Commentary Featuring POPLAR Researchers
Alicia Ault, Will a Court Ruling Push the DEA to Reschedule Psilocybin?, featuring Mason Marks in Medscape Medical News (February 12, 2024).
Senator Elizabeth Warren, United States Senate Letter to Attorney General Merrick Garland (January 29, 2024), citing Drug scheduling limits access to essential medicines and should be reformed, Nature Medicine (January 27, 2023) by Mason Marks & Carmel Shachar.
Alvin Powell, Why regulators may toss cold water on buzz over psychedelics, featuring Mason Marks in The Harvard Gazette (January 24, 2024).
Lara Goldstein, 30 Psychedelics Executives, Scientists & Influencers To Watch In 2024 And Beyond, featuring Mason Marks in Benzinga (January 10, 2024).
KQED, Push to Legalize Use of Psychedelics Resurfaces in California, featuring Mason Marks in KQED Podcast (January 9, 2024).
Sarah Glazer, Decriminalizing Psychedelics: Should hallucinogenic drugs be legalized?, featuring Mason Marks in CQ Researcher (December 15, 2023).
Daniel Gilbert & David Ovalle, FDA to review MDMA-assisted therapy, a milestone for psychedelics, featuring Mason Marks in The Washington Post (December 12, 2023).
David Scharfenberg, Massachusetts weighs the legalization of psychedelics — and the future of tripping, featuring Mason Marks in The Boston Globe (December 3, 2023).
New England Journal of Medicine, Interview with Mason Marks on draft guidance on psychedelics research, featuring Mason Marks on the New England Journal of Medicine Podcast (November 9, 2023).
Ben Adlin, Veteran Access To Psychedelics Requires Balance Of Speed And Caution, Says Panel With VA And Former CDC Officials, featuring Mason Marks and Rochelle Walensky in Marijuana Moment (November 1, 2023).
Thomas Novelly, An Air Force Academy Cadet Pleaded Guilty to Using Magic Mushrooms. Is DoD Ready for the Drug's Legal Rise?, featuring Mason Marks in Military.com (October 31, 2023).
Chris Serres, Inside the movement to legalize magic mushrooms in Massachusetts, featuring Mason Marks in The Boston Globe (October 27, 2023).
Tradeoffs, Medical or Recreational? States Debate Where Psychedelics Belong, featuring Mason Marks on Tradeoffs Podcast (October 19, 2023).
Cato Institute, Psychedelics and the Advance of Cognitive Liberty, featuring Mason Marks on Cato Daily Podcast (August 21, 2023).
Grace Browne, Psychedelic Therapy is Here. Just Don't Call it Therapy, featuring Mason Marks in WIRED (June 15, 2023).
Canadian Public Health Association, Overview of current psychedelics law in the US, featuring Mason Marks in Forum on a Public Health Approach to Psychedelics Summary Report (June 2023).
Kyle Jaeger, Top Colorado Senator Files Psychedelics Regulations Bill, Drawing Mixed Reactions, featuring Mason Marks in Marijuana Moment (April 19, 2023).
Sara Reardon, US could soon approve MDMA therapy — opening an era of psychedelic medicine, featuring Mason Marks in Nature (April 19, 2023).
Alexander Lekhtman, Major Psilocybin Business in Oregon Implodes, Casting Wider Doubts, featuring Mason Marks in Filter Magazine (March 8, 2023).
Last Week Tonight with John Oliver, Psychedelic Assisted Therapy, featuring Mason Marks and I. Glenn Cohen (February 20, 2023).
Chris Walker, More Than 200 People Applied to Be on Colorado’s Psychedelic Advisory Board, featuring Mason Marks in 5280 Magazine (February 6, 2023).
Michael Casey, Why are people turning to psychedelics like ayahuasca?, featuring Mason Marks in The Associated Press (February 2, 2023).
Alexander Lekhtman, Colorado’s Legal-Psilocybin Plan “Wide Open” as Gov. Appoints Board, featuring Mason Marks in Filter Magazine (February 1, 2023).
Chris Walker, Big Questions Surround the Rollout of Psychedelics in Colorado, featuring Mason Marks in 5280 Magazine (December 16, 2022).
Andrew Kenny, Coloradans voted to legalize psilocybin. What’s next?, featuring Mason Marks in Colorado Public Radio News (November 25, 2022).
Jonah C. Karafiol, Asher J. Montgomery & Tyler J. H. Ory, Legal Experts Discuss Regulation of Cannabis and Psychedelics at Petrie-Flom Center, featuring Carmel Shachar in The Harvard Crimson (November 11, 2022).
Elizabeth Yin, Mary Moynihan & Alexandra Walsh, Hallucinate, Medicate, and Regulate, featuring I. Glenn Cohen and Mason Marks in The Regulatory Review (August 20, 2022).
Allison Frost, Oregon psilocybin rules shape who can provide and access care, featuring Mason Marks in Oregon Public Broadcasting (June 9, 2022).
Marisa Meltzer & Dani Blum, A Ketamine Clinic Treads the Line Between Health Care and a Spa Day for Your Brain, featuring Mason Marks in NY Times (March 11, 2022).
Yale Law School, Panel Discusses Coalition Building to Unlock Therapeutic Effects of Psychedelics, featuring Mason Marks in Yale Law School Today (February 8, 2022).
Kristian Foden-Vencil, Oregon proposes using only one type of mushroom for new psilocybin system, and no pills, featuring Mason Marks in Oregon Public Broadcasting (February 8, 2022).
Rich Smith, Washington Bill to Legalize Psilocybin Mushroom Treatment Centers Won’t Pass, featuring Mason Marks in The Stranger (February 2, 2022).
Elaine McArdle, Reassessing Psychedelics, featuring Mason Marks in Harvard Law Bulletin (January 31, 2022).
Should psychedelics be more widely available?, featuring Mason Marks in Checks and Balances from the Economist (January 28, 2022).
Mount Sinai School of Medicine, MINDSET Lecture Series: Mason Marks, MD, JD, featuring Mason Marks (January 24, 2022).
The Battle Over Psychedelic Therapy’s Future, featuring Mason Marks in Vice News (January 11, 2022).
Brett Milano, The obstacles to decriminalizing psychedelic drugs are political, not legal, experts say, featuring Mason Marks in Harvard Law Today (October 13, 2021).
Rebecca Heilweil, Startups are betting on a psychedelic gold rush, featuring Mason Marks in Vox (October 13, 2021).
Tiffany Kary, Seattle Votes to Decriminalize Psilocybin and Similar Substances, featuring Mason Marks in Bloomberg Politics (October 4, 2021).
Audrey Conklin, Harvard to study psychedelics and the law as decriminalization gains steam, quoting Mason Marks and Jeanie Suk Gersen in Fox News (July 10, 2021).
Chloe Reichel, A Q&A with Mason Marks on new psychedelics law and regulation initiative, featuring Mason Marks in Harvard Law Today (July 7, 2021).
Emmy M. Cho, Harvard Law School Launches First-Ever Research Initiative on Psychedelics and the Law, quoting Mason Marks in The Harvard Crimson (July 2, 2021).
Karen Sloan, Harvard Law Dabbles in Psychedelics, featuring POPLAR in Law.com (July 2, 2021).
Shayla Love, Can LSD Treat Food Allergies? We Don't Know, But It's Already Been Patented, featuring Mason Marks in Vice News (July 1, 2021).
Shayla Love, Harvard Lawyers Will Study the Legal Questions Around Psychedelic Treatment, quoting I. Glenn Cohen & Mason Marks in Vice News (June 30, 2021).
Isabella E. Peña & Leah J. Teichholtz, Panelists Advocate for Psychedelics Decriminalization in Law School Webinar, featuring Mason Marks in The Harvard Crimson (Oct. 29, 2020).
Bill of Health Symposia
A Macro View of Microdosing, Bill of Health.
Psychedelics and America, Bill of Health.
Bill of Health Posts
Eiko I. Fried & Michiel van Elk, Common Problems in Psychedelic Science, and How to Fix Them, Bill of Health (February 2, 2024).
David Herzberg, History Rhymes with the Psychedelic Boom, Bill of Health (February 1, 2024).
Patric Plesa, The Psychedelics Industry: Psychedelic Evangelism in Second Wave Research, Bill of Health (January 31, 2024).
Caroline Hayes, Psychedelics in the Clinical Setting: The Potential for Harm and the Promise of Healing, Bill of Health (January 30, 2024).
Neşe Devenot, Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype, Bill of Health (January 29, 2024).
Vincent Joralemon, What Counts as a Psychedelic?, Bill of Health (January 26, 2024).
Jonathan Perez-Reyzin, Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market, Bill of Health (August 4, 2022).
James Jolin, Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel, Bill of Health (April 26, 2022).
Bob Wold, Small Doses of Psychedelics for Cluster Headaches, Bill of Health (April 18, 2022).
James Fadiman, A Proportionate Response to Microdosing, Bill of Health (April 15, 2022).
Joseph Rootman, Findings from the Microdose.me Study: A Large Scale Observational Study of Psychedelic Microdosing, Bill of Health (April 14, 2022).
Kelan Thomas, Safety First: Potential Heart Health Risks of Microdosing, Bill of Health (April 13, 2022).
Erin Sharoni, Restricting Access to Microdosing is Morally Wrong, Bill of Health (April 12, 2022).
Vincent Sliwoski, Microdosing at Work: Business and Legal Implications, Bill of Health (April 8, 2022).
Vince Polito, Is Microdosing Just Placebo?, Bill of Health (April 7, 2022).
Dustin Marlan, What Macrodosing Can Learn from Microdosing, Bill of Health (April 6, 2022).
Sarah Hashkes, A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation, Bill of Health (April 5, 2022).
Neşe Devenot et al., A Precautionary Approach to Touch in Psychedelic-Assisted Therapy, Bill of Health (March 9, 2022).
Mason Marks, Washington Psilocybin Bill Would Legalize Supported Adult Use, Bill of Health (January 5, 2022).
Chloe Reichel, Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative, Bill of Health (July 1, 2021).
Dustin Marlan, The Myth of Psychedelic Exceptionalism, Bill of Health (March 24, 2021).
Xinyuan Chen et al., The Cost of Exclusion in Psychedelic Research, Bill of Health (November 6, 2020).
Manoj Doss, What Psychedelic Research Can Learn from Science, and What It Can Teach, Bill of Health (November 5, 2020).
Sam S.B. Shonkoff, What the Study of Religion Can Teach Us About Psychedelics, Bill of Health (November 4, 2020).
Shelby Hartman, Can Psychedelics Help Save America?, Bill of Health (November 2, 2020).
Kathryn Lucido, The False Promise of City-Wide Psilocybin Decriminalization, Bill of Health (October 30, 2020).
Dustin Marlan, Neurodiversity and Psychedelics Decriminalization, Bill of Health (October 29, 2020).
Melissa Lavasani, Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws, Bill of Health (October 28, 2020).
Mason Marks, Psychedelics and America: A Digital Symposium, Bill of Health (October 27, 2020).
Mason Marks, As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back, Bill of Health (August 5, 2020).
Mason Marks, FDA Uses Novel Computer Simulation to Guide Kratom Policy, Bill of Health (February 8, 2018).
This research is supported by the Saisei Foundation, Tim Ferriss and Matt Mullenweg, and the Gracias Family Foundation.