A medical access issue

Unlock the research.
Expand patient access.

Psychedelic medicines are moving toward approval. Policy should open the door to research, affordable access and future treatment options, not narrow it.

Visual direction: bright, human and clinical. Approved patient, veteran or research imagery can replace this abstract treatment.
ResearchKeep the next generation of studies possible.
AccessProtect pathways beyond a single branded product.
AffordabilityPreserve competition and future treatment options.
What could be unlocked

The research is bigger than one indication.

Psychedelic research is exploring serious conditions with significant unmet need.

Research area

PTSD

Ongoing clinical investigation.
Research area

Depression

A leading area of psychedelic research.
Research area

Addiction

Alcohol, tobacco and opioid use research.
Research area

Anorexia

Early clinical research is expanding.
Research area

Chronic pain

An emerging area of investigation.
Research area

Cancer related anxiety

Research in cancer related distress.

These are areas of research and potential therapeutic investigation, not claims of approved uses. Research sources

The problem

Same molecule.
Two schedules.

FDA approval of a finished medicine does not necessarily move the underlying active ingredient out of Schedule I.

Approved medicine

Recognized medical use

S3

One finished product can become lawful under a less restrictive schedule.

≠
Underlying molecule

Still treated as Schedule I

S1

Research, formulation, supply, and broader medical innovation remain restricted.

That is bifurcated scheduling.

See the full explanation →
What is at stake

Schedule I does more than label a molecule.

It shapes who can study it, who can work with it and how new treatment models can develop.

Research

Schedule I controls add specialized registrations, protocols and handling requirements that can make studies harder to launch and scale.

Access

If only a finished branded medicine moves schedules, broader medical pathways around the underlying molecule may remain constrained.

Affordability

Future competition, formulation work and potential pharmacy pathways depend on what federal scheduling ultimately permits.

The question is not only whether a medicine gets approved. It is what happens to the molecule after approval.
See the two policy tracks →
Voices shaping the issue

The case for access is already being made.

Legal, scientific and veteran leaders are already making the case for research, responsible access and a better path forward.

Shane Pennington
“I have not met a single person who can give me a legitimate reason why this shouldn’t happen.”
Texas Law Magazine • Psilocybin Right to Try and rescheduling
Lt. Gen. Martin R. Steele, USMC (Ret.)
“The need and urgency could not be greater than it is today.”
Nevada Psychedelic Medicines Working Group
Dr. Matthew W. Johnson
“Psychedelics [are] a paradigm shifting game changer in the treatment of mental health disorders.”
Johns Hopkins Medicine • Public statement
Dr. Robin Carhart Harris
“We need to do more research to understand this.”
UCSF • Psilocybin and depression research

Placement imagery and public quotations are for design review. Final portraits, affiliations and presentation should be approved before launch and should not imply coalition membership or endorsement unless confirmed.

Legal leadership

This fight already has a legal strategy.

Shane Pennington brings direct experience with the federal machinery the coalition is working to change.

“What right does the DEA have to tell this doctor what he can and cannot do, while he is in good faith trying to heal his patients?”
PsilocybinRescheduling litigation
DEAFederal scheduling proceedings
Ninth CircuitAppellate challenge involving DEA handling of a psilocybin rescheduling petition

Draft positioning. Shane’s title, biography, portrait, Blank Rome affiliation, and public claims require Shane and Blank Rome approval before launch.

Shane's record →
Why now

The decision has not been made yet.

The coalition's goal is to put bifurcated scheduling into the conversation before federal scheduling decisions lock in the wrong outcome.

HHS recommends.   DEA schedules.   The molecule cannot be left behind.
The policy ask

Move the ingredient with the medicine.

When an FDA approved psychedelic medicine establishes accepted medical use, do not leave the bulk active ingredient in Schedule I through a brand only scheduling decision.

Research context

Homepage research areas are intentionally framed as active or emerging research, not approved indications. Final public version should link each condition to primary or institutional sources and use counsel approved language.

Join the effort

Patients should not have to wait for policy to catch up with science.

Help prevent bifurcated scheduling and protect the future of psychedelic medical research and access.

Prototype signup. Connect to coalition email platform before launch.