[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9559 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 9559
To accelerate the development of, and access to, psychedelic drugs that
could save lives and reverse the crisis of serious mental illness in
the United States, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 30, 2026
Mr. Luttrell (for himself, Mr. McCaul, Mr. Bergman, and Mr. Correa)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on the
Judiciary, and Veterans' Affairs, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To accelerate the development of, and access to, psychedelic drugs that
could save lives and reverse the crisis of serious mental illness in
the United States, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Initiating Biomedical Outcomes to
Garner Advancements into Innovative Neuroplastogen Efficacy Act'' or
the ``IBOGAINE Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Definitions.
Sec. 4. National Health Priority Voucher Pilot Program.
Sec. 5. Amendment to the Federal right to try law.
Sec. 6. Special registration requirements related to right to try.
Sec. 7. Revising considerations for DEA quota requirements.
Sec. 8. Federal-State collaboration.
Sec. 9. Interagency collaboration with the private sector.
Sec. 10. Timely rescheduling.
Sec. 11. Designation of senior official for emerging therapeutic
interventions within the Department of
Veterans Affairs.
Sec. 12. Emerging therapeutic interventions at the Department of
Veterans Affairs.
Sec. 13. Report on accelerating medical treatments for serious mental
illness.
SEC. 3. DEFINITIONS.
Section 102 of the Controlled Substances Act (21 U.S.C. 802) is
amended by adding at the end the following:
``(61) The term `ibogaine' means--
``(A) all parts of the plant Tabernanthe iboga; and
``(B) any similar compound or analog that--
``(i) acts on neuroplasticity, opioid
receptors, or serotonergic pathways that--
``(I) interrupt addiction cycles;
and
``(II) restore neurological
function disrupted by trauma, chronic
substance use, or traumatic brain
injury; and
``(ii) are distinct in mechanism from the
breakthrough therapies designated under section
506 of the Federal Food, Drug, and Cosmetic
Act.''.
SEC. 4. NATIONAL HEALTH PRIORITY VOUCHER PILOT PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
``SEC. 524C. NATIONAL HEALTH PRIORITY VOUCHER PILOT PROGRAM.
``(a) Definitions.--In this section:
``(1) Priority review.--The term `priority review', with
respect to a human drug application as defined in section
735(1), means review and action by the Secretary on such
application not later than 6 months after receipt by the
Secretary of such application, as described in the Manual of
Policies and Procedures of the Food and Drug Administration and
goals identified in the letters described in section 101(c) of
the Food and Drug Administration Amendments Act of 2007.
``(2) National health priority review voucher.--The term
`national health priority review voucher' means a voucher
issued by the Secretary to the sponsor of a national health
priority product application that entitles the holder of such
voucher to priority review of a single human drug application
submitted under section 505(b)(1) of this Act or section 351 of
the Public Health Service Act after the date of approval of the
national health priority product application.
``(3) National health priority product.--The term `national
health priority product' means any of the following:
``(A) Public health crisis response.--A product to
treat or prevent an urgent or emerging threat that the
Secretary has identified as having a significant impact
on the population of the United States.
``(B) Breakthrough therapies.--A drug that--
``(i) is designated as a breakthrough
therapy under section 506(a); and
``(ii) is a transformative treatment with
one or more novel mechanisms that fundamentally
change the management of one or more diseases
or conditions.
``(C) Large unmet medical needs.--A therapy for a
disease or condition for which existing treatments
inadequately address patient outcomes.
``(D) Onshoring and supply chain resilience.--A
product whose development or manufacture in the United
States would strengthen the Nation's domestic capacity,
reduce foreign dependency, and improve national
security with respect to the drug supply chain.
``(E) Affordability.--A product that--
``(i) improves overall value through
reduced costs to the health care system; or
``(ii) enhances access to important health
care products.
``(F) Other products.--Any other national health
priority product whose approval would--
``(i) address a health crisis in the United
States;
``(ii) deliver an innovative cure;
``(iii) address an unmet public health
need; and
``(iv) increase domestic drug manufacturing
as a matter of national security.
``(4) National health priority product application.--The
term `national health priority product application' means an
application that--
``(A) is a human drug application as defined in
section 735(1); and
``(B) is for a national health priority product.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a national
health priority review voucher to the sponsor of a national
health priority product application upon approval by the
Secretary of such application.
``(2) Prohibition on transferability.--The sponsor of a
national health priority product that receives a national
health priority review voucher may not transfer the entitlement
to such voucher, except that if ownership of the sponsor is
transferred to a different entity the entitlement to such
voucher may be transferred to such entity as part of the change
in ownership.
``(3) Limitations.--A sponsor of a national health priority
product application may not--
``(A) receive more than one national health
priority review voucher during any 24-month period; or
``(B) apply for an additional national health
priority review voucher while in possession of such a
voucher.
``(c) Priority Voucher User Fee.--
``(1) In general.--The Secretary may establish a user fee
program under which a sponsor of a human drug application that
is the subject of a national health priority review voucher
shall pay to the Secretary a fee determined under paragraph
(2). Such fee shall be in addition to any fee required to be
submitted by the sponsor under chapter VII.
``(2) Fee amount.--The amount of the user fee under
paragraph (1) shall be determined each fiscal year by the
Secretary and based on the average cost incurred by the agency
in the review of a human drug application subject to priority
review in the previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2026, for that fiscal year, the amount of the
user fee under paragraph (1).
``(4) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to
the Food and Drug Administration; and
``(B) shall not be collected for any fiscal year
except to the extent provided in advance in
appropriation Acts.
``(d) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a national health priority review voucher
from participating in any other incentive program, including under this
Act, except that no sponsor of a national priority health product
application may receive more than one national health priority review
voucher with respect to the drug for which the application is made.
``(e) Relation to Other Provisions.--The provisions of this section
shall supplement, not supplant, any other provisions of this Act or the
Public Health Service Act that encourage the development of drugs for
tropical diseases, rare pediatric diseases, or national health priority
products.
``(f) Advice.--The Secretary shall provide prompt advice to the
sponsor of a national health priority product application for which the
sponsor seeks a voucher under this section to enable the sponsor--
``(1) to plan a development program to obtain the necessary
data for approval of the national health priority product that
is the subject of such application; and
``(2) to conduct any additional studies that would be
required for approval of such product for use in a broader
population.
``(g) GAO Study and Report.--
``(1) Study.--
``(A) In general.--The Comptroller General of the
United States shall conduct a study of the
effectiveness of awarding national health priority
review vouchers in the development of human drug
products.
``(B) Contents of study.--In conducting the study
under subparagraph (A), the Comptroller General shall
examine the following:
``(i) With respect to each national health
priority review voucher awarded:
``(I) Whether, and to what extent,
an unmet need related to the treatment
or prevention of a disease or condition
was met through the approval of a
national health priority product.
``(II) Identification of each drug
for which the voucher was used.
``(III) The length of the period of
time between the date on which the
voucher was awarded and the date on
which it was used.
``(ii) Whether the pathway under this
section has helped to provide safe and
effective treatments for patients.
``(iii) Whether a similar voucher program
would be appropriate for other categories of
drugs.
``(2) Report.--Not later than 1 year after the date of
enactment of this section, the Comptroller General shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report containing the results of
the study under paragraph (1).
``(h) Termination of Authority.--The Secretary may not award a
voucher under this section after September 30, 2029.''.
SEC. 5. AMENDMENT TO THE FEDERAL RIGHT TO TRY LAW.
Section 561B(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-0a(b)) is amended by inserting ``any provision of the
Controlled Substances Act (21 U.S.C. 801 et seq.) that prohibits the
unauthorized use, possession, distribution, dispensation, or
transportation of an eligible investigational drug,'' before ``and
parts''.
SEC. 6. SPECIAL REGISTRATION REQUIREMENTS RELATED TO RIGHT TO TRY.
(a) Amendment.--Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended by adding at the end the following:
``(p) Special Registration for Schedule I Eligible Investigational
Drugs Under Right to Try.--
``(1) Definitions.--In this subsection, the terms `eligible
investigational drug' and `eligible patient' have the meanings
given those terms in section 561B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-0a).
``(2) Special registration process.--The Attorney General
shall register physicians to directly administer eligible
investigational drugs in schedule I to eligible patients under
section 561B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-0a) in accordance with paragraphs (3) through (6)
of this subsection.
``(3) Requirements.--
``(A) Application.--A physician desiring a
registration to directly administer an eligible
investigational drug as described in paragraph (2)
shall submit to the Attorney General an application
containing--
``(i) evidence of a valid registration to
dispense or administer controlled substances in
schedules II through V;
``(ii) evidence of compliance with section
561B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-0a), including--
``(I) documentation from the
manufacturer or sponsor verifying the
investigational drug in schedule I is
an eligible investigational drug;
``(II) an agreement from the
manufacturer or sponsor to supply the
eligible investigational drug, along
with guidance on its administration, to
the requesting physician for the
treatment of eligible patients; and
``(III) an affirmation that the
physician will only directly administer
the eligible investigational drug to
treat eligible patients in a manner
consistent with the guidance provided
by the manufacturer or sponsor;
``(iii) the quantity of the eligible
investigational drug to be supplied by the
manufacturer or sponsor to the physician to
treat eligible patients;
``(iv) evidence that the physician is
allowed to treat patients under the laws of the
State in which the treatment will take place;
``(v) a description of the site at which
the physician intends to store and administer
the eligible investigational drug; and
``(vi) any additional information the
Attorney General determines necessary to
prevent diversion.
``(B) Approval.--Not later than 45 days after
receiving an application containing the information
required under subparagraph (A), the Attorney General
shall--
``(i) register the applicant; or
``(ii) serve an order to show cause upon
the applicant in accordance with section
304(c).
``(4) Electronic submissions.--The Attorney General shall
provide a means for a physician to submit an application under
paragraph (3)(A) electronically.
``(5) Limitation on amounts.--A physician treating eligible
patients with an eligible investigational drug in schedule I
under this subsection may only possess the amounts of the
eligible investigational drug identified in--
``(A) the application submitted to the Attorney
General under paragraph (3)(A); or
``(B) a supplemental notification that the
physician may submit to the Attorney General if the
physician needs additional amounts of the eligible
investigational drug for the treatment of eligible
patients, which supplemental notification--
``(i) shall include--
``(I) the name of the physician;
``(II) the additional quantity of
the eligible investigational drug
needed; and
``(III) an attestation that the
treatment with the eligible
investigational drug is consistent with
the scope of treatment that was the
subject of the application under
paragraph (3)(A); and
``(ii) shall be deemed approved on the date
that is 30 days after the date on which the
physician submits the supplemental notification
to the Attorney General, unless the Attorney
General serves an order to show cause upon the
applicant in accordance with section 304(c).
``(6) Single registration for related treatment sites.--A
physician may treat eligible patients with an eligible
investigational drug in schedule I under a single registration
under this subsection if--
``(A) the treatment occurs exclusively on sites all
of which are--
``(i) within the same city or county; and
``(ii) under the control of the same
institution, organization, or agency; and
``(B) before commencing the treatment, the
physician notifies the Attorney General of each site
where the eligible investigational drug will be stored
or administered in accordance with paragraph
(3)(A)(vi).''.
(b) Rulemaking.--Notwithstanding the requirements of section 553 of
title 5, United States Code, not later than 240 days after the date of
enactment of this Act, the Attorney General shall issue an interim
final rule to implement subsection (p) (as added by this section) of
section 303 of the Controlled Substances Act (21 U.S.C. 823), including
with respect to--
(1) the manner in which an eligible investigational drug
may be delivered to an approved registrant;
(2) the storage and security of an eligible investigational
drug;
(3) the maintenance of records for an approved registrant;
(4) the process for renewal, suspension, or revocation of a
registration; and
(5) any other matters necessary to ensure effective
controls against diversion.
(c) Final Rule.--Not later than 2 years after issuing an interim
final rule under subsection (b), the Attorney General shall issue a
final rule to implement subsection (p) (as added by this section) of
section 303 of the Controlled Substances Act (21 U.S.C. 823) in
accordance with section 553 of title 5, United States Code.
SEC. 7. REVISING CONSIDERATIONS FOR DEA QUOTA REQUIREMENTS.
(a) In General.--Section 306 of the Controlled Substances Act (21
U.S.C. 826) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``total'';
(ii) by inserting ``clinical,'' after
``research,''; and
(iii) by inserting ``and paragraph (3)''
after ``(2)'';
(B) in paragraph (2), by inserting ``, in
consultation with the Secretary of Health and Human
Services,'' after ``if the Attorney General
determines''; and
(C) by adding at the end the following:
``(3) The Attorney General shall revise the annually established
production quotas within 90 days for any basic class of controlled
substance in schedule I, and within 60 days for any basic class of
controlled substance in schedule II, if any of the following triggering
events occurs during the calendar year:
``(A) A controlled substance in schedule I or II is
transferred or placed into another class of controlled
substances in accordance with applicable law.
``(B) A controlled substance in schedule I or II is
approved or cleared by the Food and Drug Administration in
accordance with the Federal Food, Drug, and Cosmetic Act.
``(C) A controlled substance in schedule I or II is
designated as a breakthrough therapy under section 506 of such
Act.
``(D) An exemption for investigational use is granted for a
drug in schedule I or II investigational use under section
505(i) of such Act.
``(E) A drug in schedule I or II is approved by the Food
and Drug Administration for use in a phase 3 clinical trial.'';
(2) in subsection (c), by adding at the end the following:
``Upon the occurrence of a triggering event listed in
subsection (a)(3) with respect to a controlled substance, a
registered manufacturer may apply for an expedited mid-year
adjustment of the manufacturing quota determined for such
manufacturer under this subsection with respect to such
controlled substance.''; and
(3) by adding at the end the following:
``(j) The Attorney General shall establish annual sufficiency
standards for each established production quota at levels necessary to
meet the legitimate medical, scientific, research, clinical, and
industrial needs of the United States.''.
SEC. 8. FEDERAL-STATE COLLABORATION.
(a) In General.--Using funds allocated pursuant to subsection (c),
the Secretary of Health and Human Services (in this section referred to
as the ``Secretary''), acting through the Director of the Advanced
Research Projects Agency--Health, the Director of the National
Institutes of Health, and the Assistant Secretary for Mental Health and
Substance Use, may partner with States, territories, and Indian Tribes
to implement programs to advance research on, and development of,
psychedelic drugs, including ibogaine, for treating serious mental
illnesses.
(b) Partnerships.--A partnership under subsection (a) may include--
(1) the award of Federal funds;
(2) the provision of technical assistance; and
(3) subject to applicable privacy and other law, sharing
data.
SEC. 9. INTERAGENCY COLLABORATION WITH THE PRIVATE SECTOR.
(a) Program.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary''), in collaboration with the
Secretary of Veterans Affairs, shall carry out a program to collaborate
with the private sector to increase clinical trial participation, data
sharing, and real-world evidence generation regarding psychedelic
drugs.
(b) Prioritizing Breakthrough Therapies.--In carrying out the
program under subsection (a), the Secretary shall prioritize
collaboration regarding psychedelic drugs that are designated as a
breakthrough therapy under section 506(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356(a)).
(c) Provision of HHS and VA Data From Clinical Studies to FDA.--
(1) Interagency agreement.--Subject to paragraph (2), the
Secretary of Health and Human Services, the Secretary of
Veterans Affairs, and the heads of other Federal departments
and agencies, shall enter into agreements to provide data from
federally conducted or supported clinical trials to the Food
and Drug Administration to facilitate the timely evaluation and
approval or licensure (as applicable) of drugs (including
biological products) under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351) or section 351 of the
Public Health Service Act (42 U.S.C. 351).
(2) Applicable provisions.--The provision of data under
paragraph (1) shall be subject to other applicable law,
including any privacy restrictions under the Privacy Act of
1974 (5 U.S.C. 552a) and the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191).
SEC. 10. TIMELY RESCHEDULING.
(a) In General.--Section 201 of the Controlled Substances Act (21
U.S.C. 811) is amended by adding at the end the following:
``(k)(1) Upon successful completion of phase 3 clinical trials for
a drug in schedule I intended to treat a serious mental health
disorder, the Attorney General, in consultation with the Secretary of
Health and Human Services, shall initiate and complete proceedings
under subsection (a) to determine whether to place such drug in another
schedule.
``(2) The Attorney General shall complete proceedings under
subsection (a) for a drug as quickly as practicable.
``(3) In this subsection, the term `phase 3 clinical trial' means
phase 3 clinical investigations conducted pursuant to an exemption for
investigational use under section 505(i) of the Federal Food, Drug, and
Cosmetic Act or section 351(a)(3) of the Public Health Service Act.''.
(b) Necessary Steps for Rescheduling Determination.--
Notwithstanding section 201 and subsections (a) and (b) of section 202
of the Controlled Substances Act (21 U.S.C. 811, 812) respecting the
scheduling of controlled substances, the Attorney General shall, by
order, not later than 60 days after the date of enactment of this Act,
take all necessary steps to determine whether to transfer ibogaine and
ibogaine compounds from schedule I of such Act to schedule II of such
Act.
SEC. 11. DESIGNATION OF SENIOR OFFICIAL FOR EMERGING THERAPEUTIC
INTERVENTIONS WITHIN THE DEPARTMENT OF VETERANS AFFAIRS.
(a) Designation.--Not later than 90 days after the date of
enactment of this Act, the Under Secretary for Health of the Department
of Veterans Affairs shall designate a senior official of the Department
to oversee policy, programs, and other activities related to emerging
therapeutic interventions.
(b) Role, Responsibility, and Authority.--The Under Secretary for
Health, in consultation with the Secretary of Veterans Affairs, shall
prescribe the roles, responsibilities, and authorities of the official
designated under subsection (a), including--
(1) assisting the Secretary of Veterans Affairs, the Deputy
Secretary of Veterans Affairs, and the Under Secretary for
Health with policies, operations, programs, and activities
relating to emerging therapeutic interventions;
(2) working in coordination with the Secretary of Health
and Human Services, the Commissioner of Food and Drugs, the
Secretary of Defense, and the Attorney General to improve the
efficiency and effectiveness of all activities related to
emerging therapeutic interventions within the Department of
Veterans Affairs; and
(3) working with Federal agencies, State and local
governments, and nongovernmental organizations to improve the
delivery of, and access to, emerging therapeutic interventions.
(c) Briefing on Designation and Implementation.--Not later than 90
days after the date of enactment of this Act, the Secretary of Veterans
Affairs shall provide a briefing to the Committees on Veterans' Affairs
of the House of Representatives and Senate on--
(1) the status of the designation of the official under
subsection (a); and
(2) the implementation of the roles, responsibilities, and
the authorities of the official under subsection (b).
SEC. 12. EMERGING THERAPEUTIC INTERVENTIONS AT THE DEPARTMENT OF
VETERANS AFFAIRS.
(a) Report.--
(1) In general.--Not later than 60 days after the date of
enactment of this Act, and biannually thereafter, the Under
Secretary for Health of the Department of Veterans Affairs
shall submit to the Committees on Veterans' Affairs of the
House of Representatives and Senate a report on the activities
of the Department with respect to emerging therapeutic
interventions, including psychedelic-assisted therapies.
(2) Contents.--At a minimum, each report under paragraph
(1) shall, with respect to emerging therapeutic interventions,
include--
(A) a summary of research activities, including a
list of active and planned clinical trials, of the
Department relating to emerging therapeutic
interventions;
(B) an identification of key findings from clinical
outcomes and patient-reported outcomes made during
clinical trials conducted or supported by the
Department;
(C) the number of veterans enrolled in treatment
programs and clinical trials related to emerging
therapeutic interventions;
(D) interagency coordination efforts of the
Department, including with the Food and Drug
Administration, the Drug Enforcement Agency, and other
relevant government agencies;
(E) recommendations to improve the delivery of
innovative therapies to veterans, including
psychedelic-assisted therapies; and
(F) recommendations for legislative or
administrative actions relating to emerging therapeutic
interventions.
(b) Workforce Readiness.--The Under Secretary for Health of the
Department of Veterans Affairs shall develop a workforce
implementation-readiness plan for emerging therapeutic interventions
(including psychedelic-assisted therapies), including--
(1) conducting a workforce-readiness assessment to identify
clinicians and peer support specialists with prior training or
certification relevant to emerging therapeutic interventions
and gaps in training, supervision, and clinical capacity
necessary to support safe and effective implementation of such
interventions;
(2) developing a standardized, competency-based training
framework for clinicians and peer support specialists
participating in emerging therapeutic interventions, including
safety monitoring, supervision standards, competent care,
interdisciplinary collaboration, and other areas where
appropriate; and
(3) developing and implementing a plan to ensure training,
using such framework, is conducted, and credentialing standards
are applied, with respect to the appropriate clinicians and
medical centers of the Department, including any centers of
excellence, in a manner designed to ensure access across each
Veterans Integrated Service Network.
SEC. 13. REPORT ON ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL
ILLNESS.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Veterans Affairs, in
collaboration with the Commissioner of Food and Drugs and the
Administrator of the Drug Enforcement Agency, shall provide a report to
the appropriate committees of Congress on the implementation of
Executive Order 14401 (91 Fed. Reg. 21709, relating to accelerating
medical treatments for serious mental illness).
(b) Appropriate Committees of Congress.--In this section, the term
``appropriate committees of Congress'' means--
(1) the Committee on Energy and Commerce of the House of
Representatives;
(2) the Committee on Veterans' Affairs of the House of
Representatives;
(3) the Committee on Health, Education, Labor, and Pensions
of the Senate; and
(4) the Committee on Veterans' Affairs of the Senate.
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