The Battle Over Legal Access to Magic Mushrooms

Pharmaceutical companies and advocates clash over the future of psilocybin rescheduling

Mar. 11, 2026 at 6:48pm

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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) has advanced a petition to the Department of Health and Human Services (HHS) to reschedule psilocybin from its current Schedule I classification, while major drug developers are aggressively lobbying for narrow, self-serving legislation at the state level.

Why it matters

The rescheduling of psilocybin could have major implications for patient access to this promising mental health treatment. If successful, moving psilocybin to Schedule II would open a pathway for access under the Right to Try Act, allowing seriously ill patients to use investigational drugs. However, pharmaceutical companies are pushing for 'bifurcation squared' strategies to ensure that any rescheduling benefits only their specific products, potentially slowing down competitors and limiting patient access.

The details

The DEA's petition, driven by legal advocates, argues for psilocybin's reclassification based on the drug's two Breakthrough Therapy Designations from the FDA for treating major depressive disorder. If successful, this would open the door for various investigational forms of psilocybin, both synthetic and natural, to be used by seriously ill patients under the Right to Try Act. In contrast, pharmaceutical companies like Compass Pathways are lobbying for narrowly-written state laws that would only reschedule their specific synthetic psilocybin formulations, potentially excluding other forms of the drug.

  • The DEA recently advanced the petition to reschedule psilocybin to the Department of Health and Human Services.
  • The HHS will next conduct a scientific and medical evaluation of psilocybin, followed by the DEA issuing a notice of proposed rulemaking and a public comment period.

The players

U.S. Drug Enforcement Administration (DEA)

The federal agency that oversees the regulation of controlled substances, including psilocybin.

Department of Health and Human Services (HHS)

The federal department that will conduct a scientific and medical evaluation of psilocybin as part of the rescheduling process.

Compass Pathways

A pharmaceutical developer of a synthetic psilocybin candidate, COMP360, that is actively lobbying for narrowly-written state laws to ensure its product is the only one rescheduled.

Filament Health

A competitor of Compass Pathways that produces naturally-derived psilocybin, and views the company's 'bifurcation squared' strategy as an attempt to create market exclusivity.

Scottsdale Research Institute

A research organization in Arizona that has some fungal trials underway that could potentially help toggle fungal psilocybin into the status of an eligible investigational drug.

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What they’re saying

“Veterans who are at risk of suicide due to PTSD will be able to have access in the context of their existing treating relationship.”

— Kathryn Tucker, Lawyer involved in the psilocybin rescheduling effort

“I want to make sure people understand 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”

— Shane Pennington, Co-counsel on the psilocybin rescheduling petition and lead counsel for federal cannabis rescheduling efforts

What’s next

The HHS will conduct its scientific and medical evaluation of psilocybin, followed by the DEA issuing a notice of proposed rulemaking and a public comment period - a key opportunity for researchers, patients, and advocates to weigh in on the drug's legal future.

The takeaway

The battle over the legal status of psilocybin highlights the complex interplay between federal rescheduling efforts, state-level legislation, and the strategies of pharmaceutical companies. The outcome will determine whether access to this promising mental health treatment will be broad or limited to a select few, raising important questions about patient rights, corporate influence, and the future of psychedelic medicine.