RN Collins has written a series of 20 new articles for cannabis law report on 2026 Psychedelics & Legal Issues.
This is the 9th in a series of 20
Congressional Action on Psychedelics: Federal Scheduling & Agency Authority
Cannabis Law Report Legislative Briefs Series
Purpose and Scope
This brief surveys congressional action on psychedelics from 2023 through early 2026, analyzes the mechanisms through which Congress has exercised legislative influence over federal scheduling and agency authority, and evaluates the current state of the federal rescheduling process for psilocybin. The brief addresses the critical intersection between congressional activity, FDA regulatory decisions, DEA scheduling authority, and the implications of federal action — or inaction — for state-licensed psilocybin programs.
I. The Federal Backdrop: Scheduling and the CSA Framework
Psilocybin and psilocin remain classified as Schedule I controlled substances under the Controlled Substances Act of 1970 (CSA), 21 U.S.C. § 812(b)(1), designated as having “no currently accepted medical use in treatment in the United States” and carrying “a high potential for abuse.”¹ MDMA, LSD, DMT, ibogaine, and mescaline are also Schedule I substances. This classification status has not changed despite decades of clinical research, two FDA Breakthrough Therapy designations for psilocybin — one for treatment-resistant depression (2018) and one for major depressive disorder (2019)³⁰ — and the emergence of two state-licensed psilocybin service programs.
The CSA establishes a two-track pathway for rescheduling controlled substances: (1) administrative rescheduling initiated by the DEA, with mandatory scientific and medical evaluation by the Department of Health and Human Services (HHS) and FDA, governed by an eight-factor analysis under 21 U.S.C. § 811; and (2) automatic rescheduling upon FDA approval of a drug containing the substance, at which point FDA must provide the HHS Secretary with an evaluation and scheduling recommendation.² The eight statutory factors DEA and HHS must consider in an administrative rescheduling proceeding include the substance’s actual or relative potential for abuse, scientific evidence of pharmacological effects, the state of current scientific knowledge regarding the substance, history and current pattern of abuse, scope and duration of abuse, any risk to public health, and the substance’s psychic or physiological dependence liability.³
Congress may also amend the schedules directly through legislation, bypassing the administrative process — as it did, for example, in scheduling fentanyl analogues — but direct legislative scheduling action remains the less common path.
II. The Landmark Congressional Action: NDAA 2024
A. Statutory Provision
The most significant congressional action on psychedelics in recent history is Section 723 of the National Defense Authorization Act for Fiscal Year 2024, Pub. L. No. 118-31, tit. VII, § 723, 137 Stat. 136 (2023), signed into law by President Biden on December 22, 2023.⁴ Section 723 directs the Secretary of Defense to “establish a process” under which active duty military service members diagnosed with post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI) may participate in clinical trials involving psychedelic substances, including psilocybin, MDMA, ibogaine, and 5-MeO-DMT, as well as “qualified plant-based alternative therapies.”
The provision allocates $10 million for these efforts and authorizes the Secretary to partner with federal or state government agencies or academic institutions to carry out the research. The Secretary is required to submit an annual report to Congress for three years following enactment describing trial findings and participation.⁵
B. Legislative History and Coalition
Section 723 was authored by Rep. Morgan Luttrell (R-TX), a former Navy SEAL who has publicly disclosed his own experience receiving ibogaine and 5-MeO-DMT treatment abroad. The provision was co-sponsored by progressive Democrats including Reps. Ro Khanna (D-CA) and Alexandria Ocasio-Cortez (D-NY) — a bipartisan coalition spanning from Texas Republican veterans to New York progressive Democrats that illustrated the distinctive cross-ideological support psychedelic reform commands on veteran mental health grounds.⁶
The provision was substantively identical to the standalone Douglas “Mike” Day Psychedelic Therapy to Save Lives Act, previously introduced by Rep. Dan Crenshaw (R-TX). By attaching the psychedelics research provision to the “must-pass” NDAA — a piece of annual legislation with a strong tradition of bipartisan support that passed the Senate 87–13 and the House 310–118 — sponsors ensured its enactment without requiring a standalone floor vote on psychedelic policy.⁷
C. Significance and Limitations
The NDAA 2024 psychedelics provision is significant as the first federal legislation expressly directing the Department of Defense to establish clinical trial processes for Schedule I psychedelic substances for therapeutic purposes. It represents Congress’s clearest statement to date that psychedelic research is a legitimate and appropriately federally funded scientific enterprise.
At the same time, the provision is carefully limited. It directs research activity, not rescheduling or access authorization. It does not exempt DoD clinical trial participants from CSA requirements; research must proceed through standard DEA Schedule I research registration and FDA IND processes. It does not create any right to access psychedelics for veterans outside clinical trials. Bradley law firm’s analysis accurately noted that the provision “doesn’t mean that psychedelics will be readily available to veterans, let alone the general public any time soon.”⁸
III. The VA’s First Psychedelic Research Funding Since the 1960s
Building directly on the NDAA 2024 provision, the Department of Veterans Affairs announced on December 3, 2024 that it would fund a study on MDMA-assisted therapy for PTSD and alcohol use disorder among veterans — the first VA-funded study of psychedelic-assisted therapy since the 1960s.⁹ The study, to be conducted by VA researchers affiliated with Brown University and Yale University, allocated up to $1.5 million over five years and was anticipated to begin enrollment in fiscal year 2025 at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut. Participants receive psychotherapy sessions enhanced by MDMA in a controlled therapeutic context.
The VA study reflects the convergence of three factors: (1) congressional appropriation authority embedded in the NDAA 2024 framework; (2) sustained advocacy by veteran-focused organizations including Veterans Exploring Treatment Solutions (VETS), Heroic Hearts Project, and Reason for Hope; and (3) a change in VA institutional posture under the Trump administration, with VA Secretary Doug Collins publicly discussing the potential of psychedelic therapies for veterans with HHS Secretary Robert F. Kennedy Jr.¹⁰
IV. The PATH Caucus and Innovative Therapies Centers of Excellence Act
A. The Psychedelics Advancing Therapies Caucus
The Psychedelics Advancing Therapies (PATH) Caucus, co-chaired by Reps. Lou Correa (D-CA) and Jack Bergman (R-MI), is the principal congressional vehicle for psychedelic policy advocacy.¹¹ The caucus represents the institutionalization of bipartisan support for psychedelic research within Congress, providing a formal vehicle for coordinating member advocacy and introducing stand-alone legislation.
B. Innovative Therapies Centers of Excellence Act of 2025
The PATH Caucus introduced the Innovative Therapies Centers of Excellence Act of 2025, its first stand-alone psychedelics legislation.¹² The bill would direct the VA to create at least five dedicated centers of excellence to study the therapeutic uses of psychedelic substances — including MDMA, ibogaine, ketamine, and psilocybin — to treat veterans experiencing anxiety, bipolar disorder, chronic pain, depression, Parkinson’s disease, PTSD, and substance use disorder. The bill would require the VA to submit a report to Congress on findings and recommendations.
The bill is co-sponsored by Reps. Morgan Luttrell (R-TX), Ro Khanna (D-CA), and Dan Crenshaw (R-TX), and is endorsed by the American Legion, Disabled American Veterans, Iraq and Afghanistan Veterans of America, Veterans of Foreign Wars, Veterans Mental Health Leadership Coalition, and Wounded Warrior Project — a coalition of major veterans’ organizations representing millions of veterans that provides significant institutional backing for federal psychedelic research legislation.¹³
V. FDA Scheduling Authority: The Lykos MDMA Rejection and Its Implications
A. FDA’s Rejection of MDMA-Assisted Therapy
On August 9, 2024, the FDA issued a Complete Response Letter (CRL) to Lykos Therapeutics (formerly the MAPS Public Benefit Corporation) declining to approve its New Drug Application for MDMA-assisted therapy for PTSD — the application that had been widely anticipated as the first FDA approval of a psychedelic medicine.¹⁴ The FDA’s Advisory Committee (PDAC) had voted in June 2024, by a 10-1 vote, that MDMA-AT’s benefits did not outweigh its risks for PTSD treatment within FDA’s proposed Risk Evaluation and Mitigation Strategy (REMS) framework.¹⁵
The FDA’s Complete Response Letter was made publicly available on September 4, 2025, when the FDA released 89 previously unpublished CRLs as part of a new transparency initiative.¹⁶ The CRL identified concerns about trial design — including “functional unblinding” (many participants could identify whether they had received MDMA or placebo), the proprietary psychotherapy protocol used in the Lykos trials, and the absence of a comparator arm using established evidence-based treatments like cognitive behavioral therapy or EMDR. MAPS characterized the CRL as revealing that “the FDA moved the goalposts,” arguing the agency had approved the Phase 3 protocol design through a formal Special Protocol Assessment process but then “shifted its standards” after trials were complete.¹⁷
The Lykos rejection has several significant implications for the federal psychedelic regulatory landscape. First, it delays MDMA-assisted therapy from reaching the market by at minimum several years — Lykos indicated it would conduct an additional Phase 3 clinical trial as required by FDA, without announcing a timeline for resubmission.³¹ Second, it signals that the FDA will apply rigorous scrutiny to psychedelic drug applications and will not approve novel therapy protocols that lack the methodological rigor and comparative design it requires from pharmaceutical applicants generally. Third, it has catalyzed other psychedelic drug developers — including Cybin, Usona Institute, and Compass Pathways — to redesign their Phase 3 trials to address the concerns the FDA raised with Lykos.¹⁸
B. The Psilocybin Rescheduling Petition: DEA to HHS
On August 11, 2025, the DEA transmitted a rescheduling petition — filed by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute — to the Department of Health and Human Services for scientific and medical evaluation.¹⁹ This transmission, following a prolonged legal battle through multiple rounds of Ninth Circuit review (culminating in Aggarwal v. U.S. Drug Enforcement Administration, No. 22-1718 (9th Cir. Oct. 27, 2023)), represents the most significant step yet toward potential psilocybin rescheduling.
Under the CSA rescheduling process, HHS must now conduct a scientific and medical evaluation and issue a scheduling recommendation to the DEA. The DEA is bound by HHS’s scientific findings but may conduct its own investigation into safety risks. If HHS recommends rescheduling to Schedule II, the DEA must initiate formal notice-and-comment rulemaking before any rescheduling can become effective — a process that could take twelve to eighteen months or longer. If HHS recommends maintaining Schedule I status, the DEA must provide notice and opportunity for hearing to the petitioner.
The institutional context for HHS’s evaluation includes supportive statements from HHS Secretary Robert F. Kennedy Jr. (who has publicly supported expanding medical access to psychedelic drugs) and FDA Commissioner Marty Makary. A prominent cannabis and psychedelics-focused attorney, Matt Zorn, who was a key figure in the psilocybin rescheduling petition, assumed the role of Deputy General Counsel at HHS in 2025 — a personnel development that the psychedelic reform community noted as potentially favorable to the petition’s prospects.²⁰
The CSA does not specify a mandatory timeline for HHS to complete its scientific and medical evaluation following a DEA referral. In prior rescheduling proceedings — most recently the 2023 cannabis rescheduling evaluation — HHS completed its evaluation in approximately eleven months. If HHS follows a similar timeline for the psilocybin petition received in August 2025, a scheduling recommendation to the DEA could be expected by mid-to-late 2026. Following an HHS recommendation, the DEA must initiate formal notice-and-comment rulemaking if rescheduling is recommended — a process that typically requires an additional twelve to eighteen months. State-licensed psilocybin programs therefore face a period of continued federal scheduling uncertainty through at least 2027 under even an optimistic timeline.³²
C. The “Bifurcated Rescheduling” Problem
A significant and underappreciated complication in the psilocybin rescheduling landscape involves what Berkeley Law panelists in November 2025 termed “bifurcated rescheduling.”²¹ When the FDA approves a pharmaceutical drug containing a Schedule I substance, the DEA typically reschedules only the specific FDA-approved product — not the underlying substance. This is precisely what occurred with synthetic THC (Marinol moved to Schedule III while cannabis remained Schedule I) and GHB (the prescription product Xywav was rescheduled, while GHB generally remained Schedule I).
The implication for psilocybin: if Compass Pathways’ COMP360 crystalline polymorph psilocybin receives FDA approval for treatment-resistant depression, the DEA may reschedule only COMP360 — leaving the broader class of psilocybin compounds in Schedule I. This “bifurcated rescheduling” scenario is precisely what multiple states addressed through trigger bills in the 2025 legislative session — including Colorado HB 25-1063, Iowa SSB 1177, Arizona SB 1555, Virginia SB 1135 (vetoed), and seven additional states identified by Berkeley Law panelists in November 2025 — legislation that creates state-level rescheduling contingent on FDA approval of “crystalline polymorph psilocybin” as a pharmaceutical product, effectively tracking the potential bifurcated federal outcome rather than assuming a broader Schedule I-to-II rescheduling.²²
The bifurcated rescheduling scenario also raises competitive implications: if only a specific patented crystalline polymorph psilocybin formulation is rescheduled, state-licensed psilocybin programs using naturally derived psilocybin mushrooms would continue to operate under Schedule I prohibition even as pharmaceutical psilocybin becomes legally prescribable.
VI. Agency Authority: FDA, DEA, and Contested Jurisdictional Questions
A. FDA Draft Psychedelic Drug Guidance
In June 2023, the FDA issued draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations,” providing the agency’s first formal guidance document specifically addressing clinical trial design for psychedelic substances.²³ The guidance highlights the “unique” characteristics of psychedelics — including the challenge of blinding (functional unblinding), the role of set and setting in treatment outcomes, the intensive therapist involvement required, and the potential for abuse — that complicate the application of standard clinical trial methodology. The guidance provides recommendations for addressing these challenges while meeting FDA’s evidentiary requirements for new drug applications.
The FDA draft guidance does not alter the Schedule I status of psychedelic substances or create new access pathways. It does signal the agency’s recognition that psychedelic drug development is a legitimate and growing area of pharmaceutical innovation requiring tailored regulatory guidance, and it provides sponsors with a clearer roadmap for designing clinical trials that will be approvable.
B. The Right to Try Act and Its Limits
The federal Right to Try Act, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, Pub. L. No. 115-176, 132 Stat. 1372 (2018), codified at 21 U.S.C. § 360bbb-0a, signed into law by President Trump in May 2018, creates a limited pathway for patients with terminal conditions to access investigational drugs that have completed Phase 1 clinical trials without requiring FDA authorization. Proponents of expanded psilocybin access have argued that the RTT Act should create a pathway for terminally ill patients to access psilocybin, which has completed multiple Phase 1, 2, and 3 trials and holds FDA Breakthrough Therapy designation.
The Ninth Circuit rejected this argument in Advanced Integrative Medical Science Institute v. U.S. Drug Enforcement Administration, No. 22-1718 (9th Cir. Feb. 13, 2025), holding that while the RTT Act exempts eligible investigational drugs from FDA approval requirements, it does not exempt them from the DEA’s registration and dispensing requirements under the CSA.²⁴ The Court found that DEA’s continued enforcement of the CSA’s registration requirement “does not affect, modify, repeal, or supersede the FDCA as amended by the RTT Act.”²⁵ The RTT pathway for psilocybin access therefore remains foreclosed absent either DEA rescheduling or a direct legislative amendment to the CSA creating an express RTT exemption from Schedule I restrictions.
C. DEA Production Quota Increases
One significant but low-visibility form of federal agency action on psychedelics involves DEA annual production quota increases for psilocybin and psilocin. In response to growing clinical trial demand and applications from DEA-registered manufacturers, the DEA has incrementally increased aggregate production quotas for research-grade psilocybin in recent years.²⁶ These quota increases do not alter scheduling status but have widened the legal supply available for approved research, facilitating the expansion of Phase 2 and Phase 3 clinical trial activity that underpins the rescheduling case.
VII. Congressional Outlook and Pending Legislation
A. IRC Section 280E Tax Implications
Beyond scheduling and access, a significant but underappreciated congressional action that would benefit state-licensed psilocybin programs involves Section 280E of the Internal Revenue Code, which prohibits deduction of ordinary business expenses for businesses “trafficking” in Schedule I or II controlled substances.²⁷ Cannabis businesses have been burdened by 280E for decades; state-licensed psilocybin service centers face the same structural disadvantage. Any rescheduling of psilocybin below Schedule II would eliminate the 280E burden for licensed businesses — one of the most commercially significant implications of federal rescheduling that has received relatively little legislative attention.
B. Psychedelic Banking Access
Analogous to the SAFE Banking Act for cannabis, the absence of congressional action on psychedelic business banking access leaves state-licensed psilocybin businesses without access to federally insured financial institutions. No psychedelic-specific banking legislation has been introduced as of early 2026. Psilocybin businesses in Oregon and Colorado operate on cash-intensive models with attendant compliance and security risks. Federal banking access for state-licensed psychedelic businesses would require either a CSA amendment reducing psilocybin to a lower schedule or explicit legislation analogous to proposed (but not enacted) cannabis banking safe harbors.
C. Innovative Therapies Centers of Excellence Act
As noted in Section IV, the PATH Caucus’s Innovative Therapies Centers of Excellence Act of 2025 is the principal stand-alone psychedelics legislation pending before Congress as of early 2026.²⁸ Endorsement by major veterans’ organizations — the American Legion, Disabled American Veterans, the VFW, and the Wounded Warrior Project — provides the bill with a politically potent backing coalition that has historically moved otherwise contentious drug policy legislation through Congress. Whether the bill advances through committee will depend on whether PATH Caucus members can secure committee hearing time and floor consideration in a Congress focused on other fiscal and policy priorities.
VIII. Implications for State Programs
The current federal trajectory has several direct implications for state-licensed psilocybin programs:
On rescheduling: If HHS recommends rescheduling psilocybin from Schedule I to Schedule II and DEA initiates formal rulemaking, the regulatory landscape for state service center programs will shift fundamentally. Schedule II status would enable DEA-registered practitioners to prescribe pharmaceutical psilocybin products while leaving state service center programs in a legally distinct category — creating the “bifurcated” access landscape analyzed in Document 5 of this series. State programs should monitor the HHS evaluation timeline closely and prepare contingency frameworks for how their licensing structures would interact with a Schedule II pharmaceutical psilocybin market — particularly whether state-licensed facilitators could administer DEA-rescheduled pharmaceutical psilocybin or whether new licensing categories would be required.
On banking: The absence of federal banking access remains the most operationally significant federal constraint on state psilocybin businesses, and congressional action to address it remains unlikely in the near term absent rescheduling or separate legislative action.
On the 280E tax burden: Rescheduling psilocybin below Schedule II would eliminate the 280E burden for licensed businesses — a commercially significant change that would improve the financial viability of service centers and potentially reduce costs to clients. The 280E burden is particularly acute for service centers, which bear the full overhead of a clinical environment — rent, staffing, security, insurance premiums — while being denied standard business expense deductions. Operators in both Oregon and Colorado have reported that 280E exposure materially affects pricing, with costs passed through to clients who are already self-paying at rates ranging from $300–$500 for group sessions to $1,000–$5,000 or more for individual sessions.
On insurance coverage: Insurance reimbursement for psilocybin services is currently unavailable given Schedule I status and the absence of FDA approval. Congressional or agency action reducing scheduling and enabling FDA approval would open the pathway to insurance coverage — a development that could transform the accessibility of psychedelic services for the majority of prospective clients who cannot currently afford out-of-pocket costs that typically range from $300–$500 for group sessions to $1,000–$5,000 or more for individual sessions, with the average individual session cost in Q1 2025 data running substantially higher than conventional outpatient therapy.²⁹ The path to insurance coverage runs through FDA approval, which triggers both the possibility of DEA rescheduling and the development of CPT billing codes — a multi-year process that the Lykos rejection has delayed by at minimum several years for MDMA, with psilocybin on a parallel but earlier timeline.
Endnotes
¹ 21 U.S.C. § 812(b)(1)(A)–(C) (2018); Drug Enforcement Administration, Psilocybin Drug Fact Sheet (2024), https://www.dea.gov/sites/default/files/2025-01/Psilocybin-Drug-Fact-Sheet.pdf.
² 21 U.S.C. § 811 (administrative rescheduling process); Regulating the Psychedelic Renaissance: FDA’s Critical Role in the Push for Scheduling Reform, 76 Admin. L. Rev. 731 (2024), https://www.americanbar.org/groups/administrative_law/resources/administrative-law-review/2024-summer/fdas-role-push-scheduling-reform-expand-research-psychedelic-medicines/.
³ 21 U.S.C. § 811(c) (eight factors for scheduling evaluation).
⁴ National Defense Authorization Act for Fiscal Year 2024, Pub. L. No. 118-31, tit. VII, § 723, 137 Stat. 136 (2023); Bradley Arant Boult Cummings LLP, Defending Psychedelics: Congress Includes Psychedelic Provisions in Defense Authorization Act (Jan. 2024), https://www.bradley.com/insights/publications/2024/01/defending-psychedelics-congress-includes-psychedelic-provisions-in-defense-authorization-act.
⁵ Pub. L. No. 118-31 § 723 (directing annual reports for three years post-enactment; authorizing DOD to partner with federal or state agencies or academic institutions; allocating $10 million).
⁶ Marijuana Moment, House and Senate Reach Deal To Require Psychedelics Clinical Trials (Dec. 7, 2023), https://www.marijuanamoment.net/house-and-senate-reach-deal-to-require-psychedelics-clinical-trials-for-active-duty-military-service-members-under-defense-bill/ (quoting Rep. Luttrell and identifying him as a veteran who has disclosed his own experience receiving ibogaine and 5-MeO-DMT treatment in another country); Bradley Arant, supra note 4 (noting co-sponsorship by Reps. Khanna and Ocasio-Cortez despite their opposing the full NDAA over FISA provisions).
⁷ Marijuana Moment, supra note 6 (NDAA passed Senate 87-13 and House 310-118); Congress.gov, Actions — H.R. 2670, National Defense Authorization Act for Fiscal Year 2024, https://www.congress.gov/bill/118th-congress/house-bill/2670/all-actions (confirming Senate passage December 13, 2023, 87-13; House passage December 14, 2023, 310-118; signed by President December 22, 2023).
⁸ Bradley Arant, supra note 4.
⁹ U.S. Department of Veterans Affairs, VA Funds First Study on Psychedelic-Assisted Therapy for Veterans (Dec. 3, 2024), https://news.va.gov/press-room/va-funds-first-study-on-psychedelic-assisted-therapy-for-veterans/ (announcing December 3, 2024; Brown University and Yale University researchers; anticipated enrollment in fiscal year 2025; up to $1.5 million over five years; first VA-funded psychedelic study since the 1960s).
¹⁰ GreenState, Magic Mushroom Rescheduling Could Be Coming (Aug. 21, 2025), https://www.greenstate.com/psychedelics/magic-mushrooms-rescheduling/ (noting HHS Secretary RFK Jr.’s regular talks with VA Secretary Doug Collins on psychedelic therapies).
¹¹ U.S. Rep. Lou Correa Press Office, Correa, Bergman Introduce Bipartisan Legislation to Require VA Study Psychedelic Treatments for Veterans, https://correa.house.gov/news/press-releases/correa-bergman-introduce-bipartisan-legislation-to-require-va-study-psychedelic-treatments-for-veterans.
¹² Id. (Innovative Therapies Centers of Excellence Act of 2025; would direct VA to designate at least five centers of excellence studying MDMA, ibogaine, ketamine, and psilocybin for veterans conditions).
¹³ Id. (endorsements from American Legion, Disabled American Veterans, Iraq and Afghanistan Veterans of America, Veterans of Foreign Wars, Veterans Mental Health Leadership Coalition, and Wounded Warrior Project).
¹⁴ MAPS, Statement on FDA’s Public Release of Complete Response Letter for MDMA-Assisted Therapy (Sept. 4, 2025), https://maps.org/2025/09/04/fda-public-release-of-crl/ (FDA issued CRL to Lykos Therapeutics on August 9, 2024, declining to approve MDMA-assisted therapy for PTSD).
¹⁵ Science, In a Setback for Psychedelic Therapy, FDA Advisers Vote Against Medical Use of Ecstasy (June 4, 2024), https://www.science.org/content/article/fda-advisory-panel-rejects-mdma-ptsd-treatment (PDAC voted 9-2 that data do not show effectiveness, and 10-1 that benefits did not outweigh risks under FDA’s proposed REMS framework).
¹⁶ U.S. Food and Drug Administration, FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89 (Sept. 4, 2025), https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89 (FDA proactively released 89 previously unpublished CRLs on September 4, 2025, including the Lykos CRL, as part of a new transparency initiative); Psychedelic Alpha, Breaking: FDA Publishes Lykos Therapeutics’ MDMA Complete Response Letter (Sept. 4, 2025), https://psychedelicalpha.com/news/breaking-fda-publishes-lykos-therapeutics-mdma-complete-response-letter-crl.
¹⁷ MAPS, supra note 14 (MAPS characterizing FDA’s CRL as revealing “the FDA moved the goalposts” by shifting standards after Special Protocol Assessment-approved Phase 3 trials were complete).
¹⁸ Healthcare Brew, What 2025 Could Bring for Psychedelic Use in Healthcare (Jan. 13, 2025), https://www.healthcare-brew.com/stories/2025/01/13/2025-psychedelic-use-healthcare (Cybin adjusting Phase 3 trial design to address Lykos concerns; Usona Institute, Awakn Life Sciences, and MindMed also in Phase 3).
¹⁹ National Psychedelics Association, DEA Advances Psilocybin Rescheduling (Aug. 11, 2025), https://yournpa.org/dea-petition/; Marijuana Moment, DEA Advances Psilocybin Rescheduling Petition (Aug. 21, 2025), https://www.marijuanamoment.net/dea-advances-psilocybin-rescheduling-petition-to-federal-health-officials-following-years-long-legal-challenge/.
²⁰ Psychedelic Alpha, 2025 Year in Review: 10 Standout Stories in Psychedelics (Jan. 2, 2026), https://psychedelicalpha.com/news/2025-year-in-review-10-standout-stories-in-psychedelics (noting Matt Zorn assumed role of Deputy General Counsel at HHS in May 2025).
²¹ Lexology, After Schedule I: Federal Psychedelic Rescheduling and the Impact on State Law (Dec. 15, 2025), https://www.lexology.com/library/detail.aspx?g=e0ccbaee-bbc0-47fc-a984-f8e22b933a30 (Berkeley Law panel on November 17, 2025 discussing bifurcated rescheduling; noting trigger bills in the 2025 legislative session focusing specifically on “crystalline polymorph psilocybin”).
²² Id. (Shahin Shams of Porta Sophia explaining bifurcated rescheduling dynamic and its intersection with state trigger legislation).
²³ FDA, Psychedelic Drugs: Considerations for Clinical Investigations (draft guidance, June 2023); King & Spalding, Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics (June 2025), https://www.kslaw.com/news-and-insights/administrative-congressional-and-state-interest-signal-a-potential-breakthrough-moment-for-psychedelics.
²⁴ Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, Pub. L. No. 115-176, 132 Stat. 1372 (2018), codified at 21 U.S.C. § 360bbb-0a; Advanced Integrative Medical Science Institute v. U.S. Drug Enforcement Administration, No. 22-1718 (9th Cir. Feb. 13, 2025); Harris Sliwoski LLP, Ninth Circuit Issues Disappointing Ruling on Terminally Ill Patients and Psilocybin (Feb. 14, 2025), https://harris-sliwoski.com/psychlawblog/ninth-circuit-issues-disappointing-ruling-on-terminally-ill-patients-and-psilocybin/.
²⁵ Harris Sliwoski LLP, supra note 24 (quoting Ninth Circuit: “Although the RTT Act itself does not require FDA approval for eligible patients to access eligible investigational drugs, it does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA”).
²⁶ King & Spalding, supra note 23 (DEA “increasing aggregate production quota for psilocybin in response to comments and quota applications from DEA-registered manufacturers”).
²⁷ I.R.C. § 280E; Reason Foundation, Psychedelics Policy Newsletter: DEA Considers Rescheduling Psilocybin (Nov. 20, 2025), https://reason.org/psychedelics-policy/psychedelics-policy-newsletter-dea-considers-rescheduling-psilocybin-fda-releases-rejection-decision-and-more/ (noting psilocybin rescheduling below Schedule II would allow state-licensed psilocybin service centers to “deduct business expenses on their federal income taxes under the ‘ordinary and necessary’ standard”).
²⁸ Rep. Correa Press Office, supra note 11.
²⁹ Psychedelic Alpha, Oregon Psilocybin Services Tracker: Q1 2025 (Oct. 2025), https://psychedelicalpha.com/news/oregon-psilocybin-services-tracker-q1-2025 (session costs ranging from $1,000 to over $5,000 for individual sessions, with group sessions starting around $300–$500; individual session costs running substantially higher than conventional outpatient therapy on average).
³⁰ FDA, Breakthrough Therapy Designation, https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy; King & Spalding, supra note 23 (confirming both psilocybin Breakthrough Therapy designations — treatment-resistant depression (2018) and major depressive disorder (2019) — and their significance to the regulatory pathway for psilocybin-based medicines).
³¹ MAPS, supra note 14 (Lykos CEO Amy Emerson stating the company would address FDA’s Phase 3 requirement; MAPS characterizing the CRL as requiring Lykos to conduct additional Phase 3 work before resubmission, without specifying a timeline for completion); see also Healthcare Brew, supra note 18 (confirming that the Lykos rejection pushes MDMA-assisted therapy approval timeline by several years minimum).
³² Drug Enforcement Administration, Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44597 (proposed rule, May 21, 2024) (illustrating the DEA notice-and-comment rulemaking timeline that follows an HHS scheduling recommendation, in that instance for cannabis; HHS completed its cannabis evaluation in approximately eleven months following referral), https://www.federalregister.gov/documents/2024/05/21/2024-10502/schedules-of-controlled-substances-rescheduling-of-marijuana.
