A 2023 House bill that would have directed the FDA to issue guidance specifically for psychedelic-assisted therapy trials — simplifying research design without touching drug scheduling.
H.R. 4242 is a single-purpose bill: it would have required the FDA to publish written guidance explaining how researchers should design clinical trials for psychedelic-assisted therapy. No rescheduling. No new access pathways. Just a clear, binding instruction to put the rules in writing.
Before 2023, the FDA had no dedicated guidance document for psychedelic trials. Sponsors had to piece together FDA expectations from dozens of general guidance documents, pre-IND meetings, and informal staff feedback. That friction raised the cost of starting a trial and slowed recruitment. H.R. 4242 aimed to fix the information gap by making the FDA publish one authoritative document.
The bill's formal title is "To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy." Representative Lou Correa (D-CA) introduced it on June 21, 2023.
The House Armed Services Committee reviewed H.R. 4242 because the primary clinical case for psychedelic research involves military populations. PTSD and traumatic brain injury (TBI) — the conditions most studied with psilocybin, MDMA, and ibogaine — are leading diagnoses among active-duty service members and veterans.
The committee was already working on psychedelic provisions for the FY2024 National Defense Authorization Act. Correa's co-sponsors included Rep. Jack Bergman (R-MI), a retired Marine general, and Rep. Morgan Luttrell (R-TX), a Navy SEAL — both members of defense committees. That gave the bill a natural home in Armed Services rather than in Energy and Commerce, which is the usual committee for FDA legislation.
This routing had practical consequences. Armed Services moved quickly on defense-related psychedelic provisions. But a bill primarily about FDA rulemaking procedures needed buy-in from Energy and Commerce to advance to the House floor. It never got that second committee hearing.
The FDA published the guidance H.R. 4242 was designed to force — before the bill could pass. On June 23, 2023, two days after the bill was introduced, the FDA published its first-ever draft guidance: Psychedelic Drugs: Considerations for Clinical Investigations.
The 14-page draft covered study design, dose-response characterization, the role of psychotherapy within a drug trial, safety monitoring requirements (two trained monitors per session for up to 12 hours), and what sponsors need to include in a New Drug Application. The comment period closed August 25, 2023.
The FDA's definition of psychedelics in the guidance included two categories: classic serotonergic psychedelics (psilocybin, LSD) and empathogens/entactogens (MDMA). That exactly matches the substances H.R. 4242 was designed to cover.
For psilocybin trials, the FDA guidance stresses characterizing the dose-response relationship before late-stage trials and addresses the "expectancy effect" — patients who know they took a psychedelic dose may improve for psychological reasons alone. FDA wants trials to account for this in their blinding design.
For MDMA trials, the guidance addresses the challenge of blinding (participants easily identify MDMA) and the role of therapist contact hours — because MDMA-assisted therapy mixes a pharmacological agent with intensive psychotherapy, FDA needs to know which element is driving any observed benefit.
H.R. 4242 emerged from the work of the Congressional Psychedelics Advancing Therapies (PATH) Caucus, a bipartisan House group co-chaired by Correa and Jack Bergman (R-MI). The caucus relaunched for the 118th Congress in early 2023, after its predecessor — the Psychedelics Advancing Clinical Treatments (PACT) Caucus — operated briefly in the 117th Congress.
The PATH Caucus explicitly avoids legalization and decriminalization. Its stated focus is on advancing clinical research within the existing FDA and DEA framework. H.R. 4242 was the caucus's most direct attempt to use Congress to speed the research pathway rather than change the legal status of any substance.
Other lawmakers in the caucus's orbit — including Dan Crenshaw (R-TX) and Morgan Luttrell (R-TX), both Navy SEALs — pushed companion legislation. Crenshaw introduced the Douglas "Mike" Day Psychedelic Therapy to Save Lives Act (H.R. 3684, June 2023), which would have funded $75 million in DOD grants for psychedelic trials for active-duty service members.
Two developments absorbed the bill's goals after it expired with the 118th Congress. The first was the FY2024 NDAA. The second was the PATH Caucus's own follow-on bill in the 119th Congress.
President Biden signed the FY2024 National Defense Authorization Act in December 2023. It included a provision — championed by Morgan Luttrell — requiring the Department of Defense to establish a process for active-duty service members with PTSD or TBI to participate in clinical trials involving psilocybin, MDMA, ibogaine, and 5-MeO-DMT. DoD received $10 million to fund the effort. This was the first-ever statutory mandate for federal psychedelic clinical trials.
Read the full analysis at NDAA Psychedelics Provision.
Correa and Bergman introduced the Innovative Therapies Centers of Excellence Act in the 119th Congress. Where H.R. 4242 targeted the FDA rulemaking problem, this bill targets the infrastructure problem: there are not enough trained researchers, therapists, or facilities to run the scale of trials FDA requires. The bill would fund at least five university-based centers dedicated to psychedelic therapy research.
Read the full analysis at Innovative Therapies Centers of Excellence Act.
On April 18, 2026, President Trump signed an executive order directing the FDA Commissioner to provide priority review vouchers to psychedelic drugs that have received Breakthrough Therapy Designation for serious mental illness. The order also directed the DEA to begin scheduling reviews for drugs completing Phase 3 trials. That executive action accomplished, by presidential directive, part of what H.R. 4242 sought through statute. See the Trump Psychedelics Executive Order guide.
The FDA's June 2023 draft guidance and H.R. 4242 addressed the same gap, but through different mechanisms with different legal weight. The table below shows where they align and where they differ.
| Feature | H.R. 4242 (bill) | FDA Draft Guidance (June 2023) |
|---|---|---|
| Legal force | Statutory — FDA legally required to act | Non-binding — FDA can amend or withdraw |
| Congressional oversight | Yes — Congress could compel compliance | No — purely administrative |
| Scope | Psychedelic-assisted therapy trials broadly | Psilocybin, LSD (classic), MDMA (empathogen) |
| IND support guidance | Required FDA to address IND request process | Covered general IND considerations |
| Scheduling change | None — no rescheduling | None — no rescheduling |
| Status | Expired — 118th Congress ended Jan 2025 | Active — guidance finalized and in effect |
Bottom line: The FDA's own action made H.R. 4242's core purpose largely moot in practice. What the bill would have added is a statutory hook — requiring the guidance to exist regardless of which administration is in power. The bill's sponsors wanted a law they could point to if a future FDA tried to quietly shelve the guidance.
H.R. 4242 is one of roughly a dozen federal psychedelic bills introduced in the 118th Congress. None became stand-alone law. But the period produced two durable outcomes: the FY2024 NDAA provision and the FDA's own draft guidance — both of which have more practical impact than the bill itself would have had.
Understanding H.R. 4242 requires knowing what it was not. It was not a legalization bill. It was not a decriminalization bill. And it was not a rescheduling bill. It was a process bill aimed at lowering the cost and uncertainty of running a federally compliant psychedelic clinical trial. For the legal status of psilocybin and MDMA today, see our guide to what psychedelics are legal in the US and the state-by-state legal status tool.
For those interested in FDA's breakthrough therapy pathway — which runs parallel to and intersects with trial guidance — see FDA Breakthrough Therapy Designation for Psychedelics. For the MDMA-specific policy picture, see where MDMA is legal.
H.R. 4242, the Psychedelic Clinical Trials Guidance Act, would have directed the FDA to publish formal guidance on how to design and run clinical trials for psychedelic-assisted therapy. It did not reschedule any drug. It simply required the FDA to tell researchers in writing what a well-designed psychedelic trial looks like.
No. H.R. 4242 was introduced in June 2023 by Representative Lou Correa (D-CA) during the 118th Congress. It passed the House Armed Services Committee markup but did not advance to a full House vote. The 118th Congress ended in January 2025 and the bill expired.
The Armed Services Committee had jurisdiction because psychedelic clinical trials for PTSD and traumatic brain injury are a military and veterans health priority. Co-sponsors Jack Bergman, Morgan Luttrell, and Dan Crenshaw were all military veterans serving on defense-related committees, and the committee was simultaneously drafting NDAA provisions on psychedelic research.
Yes, but the FDA acted on its own before the bill became law. On June 23, 2023 — days after H.R. 4242 was introduced — the FDA published its first draft guidance on psychedelic drug clinical investigations. The final guidance expanded on that draft. Congress passed the bill to ensure the agency could not later rescind the guidance without a legislative fight.
Its goals were carried forward in two ways. The FY2024 NDAA, signed December 2023, mandated that the Department of Defense run psychedelic clinical trials for service members. The PATH Caucus also introduced the Innovative Therapies Centers of Excellence Act in 2025, which would fund the university infrastructure needed to actually run those trials at scale.
No. H.R. 4242 was a research-infrastructure bill, not a legalization bill. It said nothing about removing psilocybin or MDMA from Schedule I. The only thing it would have done is direct the FDA to publish written guidance so that academic and pharmaceutical sponsors know what FDA expects from a psychedelic trial.
Representative Lou Correa (D-CA), co-chair of the PATH (Psychedelic Access Therapies for Healthcare) Caucus, introduced H.R. 4242 on June 21, 2023. Jack Bergman (R-MI), his Republican co-chair, was the leading co-sponsor. Other supporters included Morgan Luttrell (R-TX) and Dan Crenshaw (R-TX), both Navy SEALs.
The Congressional Psychedelics Advancing Therapies (PATH) Caucus is a bipartisan House caucus co-chaired by Lou Correa (D-CA) and Jack Bergman (R-MI). It focuses on advancing psychedelic research, not legalization or decriminalization. The caucus relaunched for the 118th Congress in early 2023 and has sponsored multiple bills including H.R. 4242 and the Innovative Therapies Centers of Excellence Act.
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