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Drug scheduling limits access to essential medicines and should be reformed

Nature Medicine volume 29, pages 294–297 (2023)Cite this article

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The drug-scheduling system, particularly the approach to rescheduling, should be reformed to ensure all beneficial medicines, including marijuana and psilocybin, are available to scientists and patients.

Even more concerning, the complex interaction between CSA enforcement, Food and Drug Administration (FDA) approval and the patent system creates a pharmaceutical landscape that privileges high-cost synthetic compounds over naturally occurring substances, while curtailing overall research. This system inhibits competition by granting monopolies to companies that develop proprietary therapeutics while discouraging subsequent research because of the challenges of gaining access to patented substances.

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Acknowledgements

We are grateful for the support of the Saisei Foundation and thank I. Glenn Cohen for helpful comments.

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Authors and Affiliations

  1. Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, MA, USA

    Mason Marks & Carmel Shachar

  2. Florida State University College of Law, Tallahassee, FL, USA

    Mason Marks

Authors
  1. Mason Marks
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  2. Carmel Shachar
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Correspondence to Mason Marks.

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Competing interests

Funding for this research was provided by the Saisei Foundation, a non-profit organization based in Austin, Texas. M.M. serves on the advisory boards of non-profit organizations in the psychedelics space, including the Psychedelic Medicine Coalition. M.M. is a member of the Psychedelic Bar Association.

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Marks, M., Shachar, C. Drug scheduling limits access to essential medicines and should be reformed. Nat Med 29, 294–297 (2023). https://doi.org/10.1038/s41591-022-02169-4

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