The 2023 Booker–Paul Senate bill that would have removed federal barriers to psychedelic research — and the lessons it left for its successor.
The Breakthrough Therapies Act of 2023 (S. 689) aimed to end a legal conflict at the center of US psychedelic research: the FDA had recognized psilocybin and MDMA as potential breakthrough treatments, but the DEA still classified them as having "no accepted medical use" under Schedule I.
The bill's fix was direct. Any Schedule I substance holding an FDA Breakthrough Therapy designation would move automatically to Schedule II — the category used for drugs with accepted medical use and high abuse potential, such as oxycodone and Adderall. Schedule II still restricts access but allows clinical research and, eventually, prescription use.
In practical terms, psilocybin and MDMA were the only two Schedule I substances with the designation in March 2023, so they were the bill's primary targets.
The bill amended the Controlled Substances Act in two specific ways that most coverage at the time glossed over.
Once the FDA granted a substance Breakthrough Therapy designation and it was still classified as Schedule I, the DEA would be required to move it to Schedule II. The transfer was not discretionary — it would happen by operation of the statute, not a new administrative proceeding.
This was a direct response to years of DEA inaction. The agency has a history of sitting on scheduling petitions for a decade or more. The 90-day deadline was designed to make delay legally untenable.
The bill required the DEA to issue an interim final rule within 90 days of receiving written notice from HHS that a substance had obtained — or lost — its qualifying medical use. This cut both ways: it also allowed a substance moved to Schedule II to return to Schedule I within the same window if the FDA withdrew its designation and HHS notified the DEA.
The 90-day clock was the provision the DEA and some Senate critics pushed back on hardest. Normal rulemaking under the Administrative Procedure Act can take years; 90 days for a drug scheduling change is extremely fast.
The bill did not legalize any personal use, create any retail pathway, or change state law. It also did not require the FDA to grant designations to additional substances. If no Schedule I drug ever gained a breakthrough designation, the bill would have had no effect.
S. 689 was referred to the Senate Judiciary Committee after its March 2023 introduction and never received a committee hearing. Several overlapping factors stalled it.
Critics in Congress and at the DEA argued that tying rescheduling to an FDA administrative designation — not a full five-factor scheduling review — set a dangerous precedent. The CSA requires the DEA to weigh eight statutory factors before moving a substance between schedules. The bill bypassed that review entirely.
Supporters countered that the FDA's breakthrough process already required the agency to find "substantial improvement over available therapy" — a rigorous bar. But the legal-process objection gave skeptical senators a principled reason to oppose the bill without appearing anti-research.
Throughout 2023 and early 2024, the psychedelic policy world was focused on whether the FDA would approve MDMA-assisted therapy from Lykos Therapeutics (then MAPS PBC). Many advocates preferred to wait for an approved drug — which would trigger its own rescheduling process — rather than push Congress to act. The FDA rejected the Lykos application in August 2024, removing that rationale. But by then the 118th Congress was in its final months.
The 118th Congress (2023–2024) was unusually contested on budget and national security questions. Bipartisan psychedelic legislation drew interest but not floor time. No senator with Judiciary Committee seniority pushed for a hearing, and the bill expired when the Congress ended in January 2025.
The 2025 Freedom to Heal Act (S. 3346) is the direct successor, introduced by the same four sponsors. The two bills share a goal — expanded psychedelic access — but use fundamentally different legal tools.
| Feature | Breakthrough Therapies Act (2023) | Freedom to Heal Act (2025) |
|---|---|---|
| Bill numbers | S. 689 / H.R. 1393 | S. 3346 (Senate) / House companion |
| Scheduling change | Automatic move from Schedule I to Schedule II for BTD substances | No rescheduling; substances remain Schedule I |
| Patient pathway | Via eventual prescription after FDA approval | Right to Try physician-registration with DEA — no approval needed |
| DEA role | Must issue interim rule within 90 days of HHS notice | Maintains oversight via special physician-registration system |
| Qualifying criterion | FDA Breakthrough Therapy designation | Phase I clinical trial completion; eligible investigational drug status |
| Substances in scope | Psilocybin and MDMA (only Schedule I BTD holders in 2023) | Any Schedule I EID — broader potential scope |
| Status | Did not pass — 118th Congress | Pending — 119th Congress (as of mid-2026) |
The pivot from rescheduling to a Right to Try model was strategic. By not touching the schedule, the Freedom to Heal Act sidesteps the "bypassing the CSA process" objection that helped sink S. 689. It also mirrors language from the existing Right to Try Act of 2018, giving it a legislative analogy with broad bipartisan precedent. For a full comparison, see our Freedom to Heal Act guide.
The Breakthrough Therapies Act did not become law, so it has no direct legal effect in 2026. Psilocybin and MDMA are still Schedule I. But the bill matters for two practical reasons.
S. 689 was the first bill to propose automatic, designation-triggered rescheduling at the federal level. The 90-day DEA deadline it contained became a template that later reform proposals reference. Even the Freedom to Heal Act's Right to Try architecture was shaped partly by the backlash S. 689 received for trying to move too fast on scheduling.
Because the Breakthrough Therapies Act did not pass and the Freedom to Heal Act is still pending, the clearest legal route to psilocybin or MDMA access in the US today is a clinical trial. The FDA's Breakthrough Therapy Designation speeds trial review but does not open the door outside a trial. If you are looking for legal psilocybin access outside a trial, Oregon and Colorado have licensed programs. See our psilocybin legal status guide and the legal status by state tool.
After the 2024 FDA rejection of Lykos's MDMA therapy application, MDMA has no approved therapeutic use in the US. Access is through clinical trials only. Australia's 2023 TGA rescheduling remains the only jurisdiction where doctors can legally prescribe MDMA for PTSD. For MDMA legality worldwide, see the MDMA legal status guide.
The Breakthrough Therapies Act of 2023 (S. 689) was a bipartisan Senate bill introduced by Senators Cory Booker (D-NJ) and Rand Paul (R-KY). It would have amended the Controlled Substances Act to move psilocybin and MDMA — both holding FDA Breakthrough Therapy designations — from Schedule I to Schedule II, and required the DEA to process related research applications within 90 days.
Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced S. 689 in March 2023. Representatives Madeleine Dean (D-PA) and Nancy Mace (R-SC) introduced the companion House bill, H.R. 1393, in the same month.
No. The bill was referred to the Senate Judiciary Committee but never received a hearing or a floor vote. The 118th Congress ended in January 2025 without passage. The same sponsor team returned in 2025 with a revised bill called the Freedom to Heal Act (S. 3346).
The Breakthrough Therapies Act (2023) pursued automatic rescheduling: any substance with an FDA Breakthrough Therapy designation would move from Schedule I to Schedule II. The Freedom to Heal Act (2025) does not reschedule any substance. Instead, it creates a Right to Try physician-registration pathway so licensed doctors can apply to the DEA to administer Schedule I drugs to seriously ill patients — without changing the underlying schedule.
The bill was referred to the Senate Judiciary Committee after introduction in March 2023 and never received a hearing. Critics argued that automatic rescheduling tied to an FDA designation bypassed the DEA's statutory eight-factor scheduling review. The bill also competed with the active MDMA FDA approval process and had no Senate Judiciary champion willing to call a hearing before the 118th Congress expired.
The bill applied to any Schedule I controlled substance holding an FDA Breakthrough Therapy designation. In practice, psilocybin and MDMA were the only two Schedule I substances with that designation at the time of introduction in 2023. Both remain Schedule I as of 2026.
The Freedom to Heal Act (S. 3346, 119th Congress), introduced in late 2025 by the same four sponsors — Booker, Paul, Dean, and Mace — is the successor. Rather than rescheduling, it creates a DEA special-registration pathway for physicians to administer Schedule I eligible investigational drugs to seriously ill patients, modeled on the existing Right to Try framework.
Yes. Senators Booker and Paul first introduced an earlier version, S. 5123, in December 2022 during the 117th Congress. It also expired without a hearing. The 2023 reintroduction added House companion bills and refined the 90-day scheduling mechanism.
Both psilocybin and MDMA remain Schedule I controlled substances under the Controlled Substances Act as of 2026. Oregon and Colorado have state-level legal psilocybin programs, but neither changes federal classification. Australia became the first country to legally prescribe both substances in 2023. Check the psychedelic legalization tracker for current status.
The bill required the DEA to issue an interim final rule within 90 days of receiving an HHS notification about a substance's scheduling change — both to transfer a breakthrough-therapy-designated substance into Schedule II and, if the designation was later withdrawn, to move it back to Schedule I. This was designed to end the DEA's long-running practice of delaying scheduling decisions for years while research evidence accumulated.
The Breakthrough Therapies Act is one of more than a dozen federal bills introduced since 2020. Our tracker covers current status, key dates, and how each bill would change access for patients and researchers.
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