The legal status of psilocybin, the psychoactive compound found in “magic mushrooms,” is entering a critical phase, defined by two simultaneous battles that will determine whether access to the promising mental health treatment will be broad or limited to a handful of pharmaceutical giants.
The U.S. Drug Enforcement Administration (DEA) recently advanced a petition to the Department of Health and Human Services (HHS) that seeks to reschedule psilocybin from its current classification as a Schedule I substance—which implies a high potential for abuse and no accepted medical use—to Schedule II. This federal action, coupled with aggressive lobbying by major drug developers for narrow, self-serving legislation at the state level, sets the stage for a policy showdown over future patient access.
The Legal Pathway to Schedule II
The petition, driven by the work of legal advocates, argues for psilocybin’s reclassification based on a rarely used provision of the Controlled Substances Act. Since psilocybin has already received two Breakthrough Therapy Designations from the Food and Drug Administration (FDA) for treating major depressive disorder, lawyers contend the drug has a “currently accepted medical use with severe restrictions”
If successful, moving the substance to Schedule II would have massive implications, most immediately opening a pathway for access under the Right to Try Act. This federal law allows patients with life-threatening conditions to access investigational drugs that have passed Phase I safety trials.
“Veterans who are at risk of suicide due to PTSD will be able to have access in the context of their existing treating relationship,” said Kathryn Tucker, a lawyer involved in the effort She and co-counsel Shane Pennington spearheaded the legal challenge that pressured the DEA to advance the petition.
The next critical step in the federal process is for the HHS to conduct its scientific and medical evaluation. Following this, the DEA would issue a notice of proposed rulemaking, which triggers a public comment period. This is a key opportunity for researchers, patients, and advocates to weigh in on the drug’s legal future.
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The Corporate Strategy: “Bifurcation Squared”
Looming large over the federal rescheduling effort is a corporate strategy aimed at ensuring that any downscheduling benefits are channeled exclusively toward a company’s specific product. This is known as bifurcated scheduling, where an FDA-approved prescription formulation of a substance is downscheduled, while all other forms of the substance remain in Schedule I.
In the psilocybin space, this strategy is being taken a step further—what has been dubbed “bifurcation squared” by Josh Hardman – founder of Psychedelic Alpha. The strategy is being advanced by Compass Pathways, the pharmaceutical developer of the synthetic psilocybin candidate COMP360.
Compass Pathways is actively lobbying for narrowly-written trigger laws at the state level that would exempt only its specific product, or a narrow class of compounds, from state Schedule I restrictions upon federal approval.
For example, one Colorado bill supported by Compass would only reschedule their synthetic “crystalline polymorph psilocybin” formula, which is the term the company uses to describe its patented formulation. In theory, approval of Compass’ formula specifically could effectively exclude naturally-derived psilocybin and amorphous synthetic forms from automatically being rescheduled in the state, even if they obtain FDA approval down the line.
The company is taking an even more direct approach in Virginia, where a bill was introduced that refers specifically and only to the FDA-approved prescription drug COMP360.
Competitors, such as Filament Health, whose product is naturally-derived psilocybin, view this tactic as unsurprising but note that it highlights the bureaucratic absurdity of the controlled substances regime, where companies are forced to lobby state-by-state to clear a path for their own drugs.
On the flipside, Kathryn Tucker – co-counsel for the psilocybin rescheduling petition, noted in an interview for the Psychedelic State(s) of America Advocacy Spotlight Initiative in September that, “the Scottsdale Research Institute in Arizona has some fungal trials underway that could suddenly toggle fungal psilocybin into the status of eligible investigational drug.” Tucker further noted that such a potential development would be a win for naturally-derived psilocybin’s federal standing, “assuming… The requirements of The Right to Try law are also met.”
Broad Access vs. Exclusivity
The push for Schedule II, driven by advocates and the legal team, aims for a classification that would broadly apply to psilocybin, opening the door for various investigational forms – both synthetic and natural – to be used by seriously ill patients under the Right to Try Act
In contrast, the “bifurcation squared” strategy is seen by many in the psychedelic community as an attempt by the for-profit pharmaceutical sector to buy time and create market exclusivity beyond the protections offered by patents, potentially slowing down competitors and limiting patient access to all but the most expensive, brand-name formulations.
Shane Pennington, Tucker’s co-counsel on the psilocybin rescheduling petition and current lead counsel for federal cannabis rescheduling efforts as well, noted, “People ask [him] about” bifurcated scheduling “all the time.”
“I want to make sure people understand,” Pennington expounded, “that if the FDA were to approve… Compass Pathway’ compound, and if there were to be bifurcated rescheduling… and then our petition is approved to move psilocybin to Schedule II… that would mean that for purposes of that severe restrictions bit, for Right to Try access and perhaps other things, any psilocybin would potentially have the Schedule II classification”
However, Pennington also cast doubt on the long-term viability of Compass’ Pathways’ vision for bifurcated scheduling. “I think this entire idea of bifurcated scheduling is illegal, and I’ve always kind of wanted to bring the right case to challenge it” he explained..
“I don’t think it makes any sense, and I don’t think it would pass muster under judicial review,” Pennington concluded, “but that’s an issue for another day.”
As the federal petition awaits review by the HHS, the fate of psilocybin legalization hangs in the balance: a potential victory for broad access and patient autonomy through the Schedule II pathway, or a future where the medicine is tightly controlled by a few corporate entities armed with narrow, self-serving legislation. The upcoming public comment period is widely viewed as the next major opportunity for the public to influence which path is taken.
