The 2025 Booker–Paul–Dean–Mace bipartisan bill that would reschedule psilocybin and MDMA and create a federal research-to-access pathway.
The Freedom to Heal Act would reschedule psilocybin and MDMA from Schedule I, reduce regulatory barriers for researchers, and create a pathway to supervised access for patients with serious conditions. It is the most far-reaching federal psychedelic reform bill of the 119th Congress.
The rescheduling component would move psilocybin and MDMA out of the most restrictive federal drug category — one that, under current law, carries a presumption of no accepted medical use — and open the door to standard prescribing once FDA marketing approval follows. The supervised-access pathway runs in parallel, allowing patients with life-threatening conditions to reach these substances through a registered physician without waiting for full FDA approval.
The bill also directly addresses the DEA's longstanding position that it has no mechanism to register physicians for Schedule I substances under the 2018 Right to Try law. By building a new registration category alongside the scheduling change, the bill closes both the scheduling gap and the access gap simultaneously.
Booker is a progressive Democrat who has championed mental health access; Paul is a libertarian Republican who opposes government barriers to patient choice. Their joint sponsorship — used on three bills now since 2021 — is a deliberate signal that this is not a blanket drug-legalization bill. It is a patient-autonomy and research-access bill, which makes it harder to dismiss on ideological grounds.
Alongside the rescheduling provision, the Freedom to Heal Act creates a new supervised-access pathway for patients who cannot wait for the full FDA marketing approval process. A physician licensed anywhere in the United States can submit an application to the DEA for a special registration to administer psilocybin or MDMA to qualifying patients.
The bill requires the DEA to act within 45 days. After receiving an application, the Attorney General must either approve the registration or issue a formal show-cause order explaining the denial. This is a hard statutory clock — a detail absent from most federal drug-access proposals, and one that stops the DEA from sitting on applications indefinitely.
Applications must be accepted electronically. A single registration can cover multiple clinical sites in the same city or county, as long as the same organization controls all of them. Physicians may only possess the quantity of substance specified in their approved application, and must request a supplemental notification before receiving additional amounts.
Under the supervised-access pathway, patients must have a life-threatening condition and must have exhausted or be unable to tolerate standard treatment options. This mirrors the existing federal Right to Try standard from the 2018 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act.
The patient must be in a physician-patient relationship with the registered doctor. There is no open-access pathway under this provision — patients cannot self-refer or purchase these substances independently. Every administration requires a physician who holds a DEA registration under the new category.
The drug being used must be an eligible investigational drug (EID). An EID has completed Phase 1 clinical trials and received FDA Breakthrough Therapy designation. This bar is deliberately set to match where psilocybin and MDMA already sit, so the pathway opens immediately if the bill becomes law. The rescheduling provision, once in effect, would then enable standard prescription access as FDA approval follows.
Psilocybin and MDMA are the two substances the bill's sponsors specifically name, and both already carry FDA Breakthrough Therapy designation — the threshold the EID standard is built around.
Psilocybin received Breakthrough Therapy designation for treatment-resistant depression in 2018 and for major depressive disorder in 2019. MDMA received the designation for PTSD in 2017. Both have advanced into Phase 2 and Phase 3 trials. See our psilocybin therapy guide and MDMA therapy guide for the current trial landscape.
The EID definition in the bill is not limited to these two substances. Any Schedule I substance that completes Phase 1 and earns Breakthrough Therapy designation could qualify in the future — including compounds like ibogaine, which is under active study for opioid dependence and PTSD.
The Freedom to Heal Act is the third federal psychedelic access bill that Booker and Paul have introduced together, and each version has taken a different legal strategy to solve the same problem.
The two bills share the same sponsor team and the same goal — expanding patient access to psilocybin and MDMA — but the Freedom to Heal Act goes considerably further than its predecessor in scope.
| Feature | Breakthrough Therapies Act (2023) | Freedom to Heal Act (2025) |
|---|---|---|
| Primary mechanism | Mandatory rescheduling from Schedule I to II triggered by FDA designation | Rescheduling from Schedule I + new supervised-access physician pathway + reduced research barriers |
| Effect on scheduling | Moves substance to Schedule II if FDA designates breakthrough | Moves psilocybin and MDMA from Schedule I |
| Who gets access | Any patient prescribed by a physician (Schedule II rules apply) | Supervised-access pathway for patients with life-threatening conditions; broader access once rescheduling and FDA approval align |
| DEA role | Must execute the transfer on FDA's trigger | Executes rescheduling; reviews physician applications under 45-day deadline |
| Research barriers | Not directly addressed | Explicitly reduced — researchers face fewer regulatory hurdles |
| Breadth | Narrower scope — focused on rescheduling trigger only | Broader — rescheduling + access pathway + research provisions |
| Status (as of June 2026) | Did not advance in 118th Congress | Pending Senate Judiciary; 119th Congress |
Why the Freedom to Heal Act represents an escalation: where the Breakthrough Therapies Act focused on a single rescheduling trigger tied to FDA designation, the Freedom to Heal Act combines rescheduling with an immediate supervised-access pathway and direct regulatory relief for researchers — making it the most comprehensive federal psychedelic reform bill introduced to date.
The Freedom to Heal Act faces the same structural obstacle every psychedelic bill has faced in Washington: Senate committee gatekeeping and floor-time competition in a packed legislative calendar.
The bill's bipartisan sponsorship reduces (but does not eliminate) opposition. Critics on the left worry that rescheduling without full FDA approval bypasses safety standards; critics on the right worry about any federal expansion of drug access. The Senate Judiciary Committee, where S.3346 was referred, has a heavy caseload and no scheduled hearing on the bill.
The April 2026 Trump executive order directed the FDA and DEA to accelerate review of psychedelic breakthrough therapies. That order did not create the physician-registration pathway the Freedom to Heal Act would build, but it does signal White House interest in psychedelic policy — a shift that could lower the political cost of a committee hearing. For full context on the EO, see our Trump psychedelics executive order guide.
The psychedelic legalization tracker lists the current status of this bill alongside every other active federal and state measure. Use it to track committee assignments and hearing notices as they are announced.
Veterans with treatment-resistant PTSD are the most visible constituency the Freedom to Heal Act's sponsors cite, and for concrete reasons.
MDMA-assisted therapy produced a 67–71% response rate in Phase 3 trials published in Nature Medicine in 2021 — the strongest published signal for any PTSD treatment, including first-line pharmacotherapy. Veterans with combat-related PTSD who have failed selective serotonin reuptake inhibitors (the standard of care) have few remaining options under current law.
The bill would allow a VA physician or private physician treating a veteran to apply for a DEA registration and administer MDMA or psilocybin in a clinical setting — without waiting for FDA marketing approval or enrolling the veteran in a formal trial. Iraq and Afghanistan Veterans of America (IAVA) listed the bill as a legislative priority in its 2026 advocacy platform. See the NDAA psychedelics provision guide for the related Defense Department research mandate that passed into law in 2023.
The Freedom to Heal Act sits inside a broader cluster of federal psychedelic legislation, executive action, and regulatory movement that accelerated between 2023 and 2026.
The key federal pieces are: the FDA Breakthrough Therapy designations for psilocybin and MDMA (which the bill's eligible investigational drug standard is built around); the 2018 Right to Try Act (which the bill's access pathway builds on); the 2023 NDAA provision directing the DoD to study psychedelic-assisted therapy for veterans; and the April 2026 Trump executive order directing agency reviews. None of these created a rescheduling pathway or broad legal patient-access pathway. The Freedom to Heal Act is the only federal bill with active sponsors that would do both as of June 2026.
State-level access is further along. Oregon has been running licensed service centers since 2023. Colorado's healing centers opened in 2025. For the current state-by-state picture, use the legal status by state tool or read our guide on what psychedelics are legal in the US.
The Freedom to Heal Act, if enacted, would not override or replace state programs. It would create a parallel federal pathway for the most seriously ill patients — filling a gap that state healing-center models are not designed to fill, since those programs are wellness-oriented, not clinical-condition-specific.
The Freedom to Heal Act (S.3346 / H.R.6434) would reschedule psilocybin and MDMA from Schedule I, reduce regulatory barriers for researchers, and create a supervised-access pathway for patients with serious conditions. It is the most far-reaching federal psychedelic reform bill of the 119th Congress.
Yes. The Freedom to Heal Act would reschedule psilocybin and MDMA from Schedule I. It also creates a supervised-access pathway for patients with serious conditions and reduces regulatory barriers for researchers — three components working together to open clinical and research access.
The Freedom to Heal Act was introduced in December 2025 by Senators Cory Booker (D-NJ) and Rand Paul (R-KY) in the Senate (S.3346), with companion legislation from Representatives Madeleine Dean (D-PA) and Brian Mace (R-FL) in the House (H.R.6434). The bipartisan, bicameral sponsorship combines Booker's mental health focus with Paul's libertarian Right to Try philosophy.
The bill works on two tracks. First, the rescheduling provision would enable standard physician-prescribing access once FDA marketing approval is in place. Second, the supervised-access pathway allows patients with a life-threatening condition who have exhausted standard treatments to access these substances now — through a physician who holds a special DEA registration. The drug must also be an eligible investigational drug that has cleared at least Phase 1 clinical trials. Both psilocybin and MDMA already meet this standard.
Both bills come from the same Booker-Paul sponsor team. The Breakthrough Therapies Act (2021, 2023) would have required the DEA to transfer FDA-designated breakthrough therapies from Schedule I to Schedule II — a narrowly targeted rescheduling trigger. The Freedom to Heal Act goes further: it would reschedule psilocybin and MDMA from Schedule I, add a supervised-access pathway for patients with serious conditions, and reduce regulatory barriers for researchers — a broader, multi-component approach.
As of June 2026, the Freedom to Heal Act (S.3346) is pending in the 119th Congress. The Senate bill was referred to the Senate Judiciary Committee after introduction in December 2025. It has not received a committee hearing or a floor vote. The House companion, H.R.6434, was introduced simultaneously by Representatives Dean and Brian Mace (R-FL).
Veterans are a named priority of the Freedom to Heal Act. MDMA has shown strong results in published Phase 3 trials for PTSD — a condition that disproportionately affects combat veterans who have not responded to standard care. The physician-registration pathway would allow VA-affiliated or private doctors to administer MDMA or psilocybin to veteran patients who qualify under the life-threatening-condition standard.
No. Under current federal law, no physician can administer Schedule I substances outside of an approved clinical trial. The DEA has no existing registration pathway for Right to Try patients — the exact gap the Freedom to Heal Act is designed to fill.
Booker and Paul introduced the Breakthrough Therapies Act in 2021 and again in March 2023 with Dean and Brian Mace (R-FL) in the House. Both versions would have required expedited rescheduling of FDA-designated breakthrough therapies. Neither advanced past committee referral. The Freedom to Heal Act (2025) takes an expanded approach — rescheduling psilocybin and MDMA from Schedule I while adding a supervised-access pathway and research regulatory relief.
It does not require FDA marketing approval, but the drug must have passed Phase 1 clinical trials and hold FDA Breakthrough Therapy designation. Both MDMA and psilocybin already meet this bar. The bill builds on the Breakthrough Therapy designation but does not wait for full FDA approval.
The full text of S.3346 is available on Congress.gov at the Library of Congress. The House companion, H.R.6434, is also on Congress.gov. Both were introduced in December 2025 during the 119th Congress.
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