Scientific American commentator Mason Marks, a law professor, examines three roads to making psilocybin easier for researchers – and people who need clinical help – to work with without falling afoul of the law:
Despite overwhelming evidence that psilocybin is misclassified, this barrier restricts research, stifles competition and innovation, and inhibits access. Amid a worsening mental health crisis, the dam preventing scientific progress must be broken.
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The [Controlled Substances Act] does not define currently accepted medical use. But federal lawsuits on cannabis rescheduling provide guidance and suggest that FDA approval is not a requirement for meeting that criterion. Instead, qualifying evidence may come from adequate and well-controlled clinical trials. Phase I trials should be sufficient, and many have been completed using psilocybin.
In Oregon, the Research Subcommittee of the Oregon Psilocybin Advisory Board, composed of physicians, biologists and public health officials, analyzed the research and concluded that “high quality phase [I and II] clinical trials suggest that psilocybin is efficacious in reducing depression and anxiety, including in life-threatening conditions.” One recent phase II trial, discussed in the New England Journal of Medicine, demonstrated that two doses of psilocybin administered three weeks apart treated depression as effectively as six weeks of daily escitalopram, a common SSRI.
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Substances can be rescheduled through three legal pathways. The first is legislative. Congress could reschedule psilocybin by amending the CSA. Historically, attempts to reschedule cannabis through this pathway have failed.
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The second rescheduling pathway is administrative. The CSA gives the federal attorney general power to schedule and reschedule substances or remove them from the controlled substances list. That power is typically delegated to the DEA. President Biden could sign an executive order compelling the DEA to reschedule psilocybin. Alternatively, members of the public, and government officials, could petition the DEA to act. However, though the rescheduling process is distinct from FDA approval, the DEA typically resists rescheduling without it.
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The third pathway to rescheduling is judicial, which involves suing the DEA after it denies a scheduling petition. Though lawsuits filed to compel rescheduling of cannabis have been unsuccessful, they have provided a roadmap for rescheduling psilocybin, including the required standards for reviewing a petition and evaluating currently accepted use. Considering potential DEA and Congressional opposition to psilocybin rescheduling, the judicial path may be the most effective. But legislative approaches may soon become more feasible because psychedelics law reform is increasingly a bipartisan issue.