[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 326 Reported in Senate (RS)]
<DOC>
Calendar No. 32
118th CONGRESS
1st Session
S. 326
To direct the Secretary of Veterans Affairs to carry out a study and
clinical trials on the effects of cannabis on certain health outcomes
of veterans with chronic pain and post-traumatic stress disorder, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 9, 2023
Mr. Tester (for himself, Mr. Sullivan, and Ms. Duckworth) introduced
the following bill; which was read twice and referred to the Committee
on Veterans' Affairs
March 23, 2023
Reported by Mr. Tester, without amendment
_______________________________________________________________________
A BILL
To direct the Secretary of Veterans Affairs to carry out a study and
clinical trials on the effects of cannabis on certain health outcomes
of veterans with chronic pain and post-traumatic stress disorder, 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 ``VA Medicinal Cannabis Research Act
of 2023''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Covered veteran.--The term ``covered veteran'' means a
veteran who is enrolled in the patient enrollment system of the
Department of Veterans Affairs established and operated under
section 1705(a) of title 38, United States Code.
(2) Secretary.--The term ``Secretary'' means the Secretary
of Veterans Affairs.
SEC. 3. DEPARTMENT OF VETERANS AFFAIRS LARGE-SCALE, MIXED METHODS,
RETROSPECTIVE QUALITATIVE STUDY ON THE EFFECTS OF
CANNABIS ON CERTAIN HEALTH OUTCOMES OF VETERANS WITH
CHRONIC PAIN AND POST-TRAUMATIC STRESS DISORDER.
(a) Study Required.--
(1) In general.--The Secretary, through the Office of
Research and Development of the Department of Veterans Affairs,
shall carry out a large-scale, mixed methods, retrospective,
and qualitative study on the effects of cannabis on the health
outcomes of covered veterans diagnosed with chronic pain and
covered veterans diagnosed with post-traumatic stress disorder.
(2) Observational study.--The study required by paragraph
(1) shall be conducted as an observational study on the effects
of cannabis use on the health of covered veterans.
(3) Elements.--
(A) In general.--The study required by paragraph
(1) shall--
(i) triangulate a range of data sources;
(ii) compare the positive and negative
health outcomes of covered veterans who use
cannabis, utilizing outcomes that can be
measured in an electronic health record of the
Department and through data sets of the
Department relating to claims for benefits
under the laws administered by the Secretary;
(iii) elicit the positive and negative
outcomes of cannabis use for covered veterans
through semi-structured interviews;
(iv) estimate current and future health
system needs to address positive and negative
outcomes of cannabis use for covered veterans;
(v) include a qualitative, open-ended
survey provided to covered veterans who have
sought care from the Department for chronic
pain or post-traumatic stress disorder during
the five-year period preceding the survey; and
(vi) include an assessment of--
(I) all records within the Veterans
Health Administration for covered
veterans participating in the study;
and
(II) all records within the
Veterans Benefits Administration for
covered veterans participating in the
study.
(B) Health outcomes.--A comparison of health
outcomes under subparagraph (A)(ii) shall include an
assessment of the following:
(i) The reduction or increase in opiate use
or dosage.
(ii) The reduction or increase in
benzodiazepine use or dosage.
(iii) The reduction or change in use of
other types of medication.
(iv) The reduction or increase in alcohol
use.
(v) The reduction or increase in the
prevalence of substance abuse disorders.
(vi) Sleep quality.
(vii) Osteopathic pain (including pain
intensity and pain-related outcomes).
(viii) Agitation.
(ix) Quality of life.
(x) Mortality and morbidity.
(xi) Hospital readmissions.
(xii) Any newly developed or exacerbated
health conditions, including mental health
conditions.
(b) Implementation.--Not later than 180 days after the date of the
enactment of this Act, the Secretary shall commence the implementation
of the study required by subsection (a)(1).
(c) Duration of Study.--The study required by subsection (a)(1)
shall be carried out for an 18-month period.
(d) Report.--
(1) In general.--Not later than 90 days after the
completion of the study required by subsection (a)(1), the
Secretary shall submit to the Committee on Veterans' Affairs of
the Senate and the Committee on Veterans' Affairs of the House
of Representatives a report on the study.
(2) Ability to conduct clinical trials.--The Secretary
shall include in the report required by paragraph (1) an
assessment of whether the Secretary is able to meet the
criteria necessary to conduct the clinical trials required
under section 4, including consideration of subsection (e)(1)
of such section.
SEC. 4. DEPARTMENT OF VETERANS AFFAIRS CLINICAL TRIALS ON THE EFFECTS
OF CANNABIS ON CERTAIN HEALTH OUTCOMES OF VETERANS WITH
CHRONIC PAIN AND POST-TRAUMATIC STRESS DISORDER.
(a) Clinical Trials Required.--
(1) In general.--If the Secretary indicates in the report
required by section 3(d) that the Secretary is able to meet the
criteria necessary to proceed to clinical trials, commencing
not later than 180 days after the submittal of that report, the
Secretary shall carry out a series of clinical trials on the
effects of cannabis appropriate for investigational use, as
determined by the Food and Drug Administration under section
505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)), on the health outcomes of covered veterans diagnosed
with chronic pain and covered veterans diagnosed with post-
traumatic stress disorder.
(2) Considerations.--The clinical trials required by
paragraph (1) shall include, as appropriate, an evaluation of
key symptoms, clinical outcomes, and conditions associated with
chronic pain and post-traumatic stress disorder, which may
include--
(A) with respect to covered veterans diagnosed with
chronic pain, an evaluation of the effects of the use
of cannabis on--
(i) osteopathic pain (including pain
intensity and pain-related outcomes);
(ii) the reduction or increase in opioid
use or dosage;
(iii) the reduction or increase in
benzodiazepine use or dosage;
(iv) the reduction or increase in alcohol
use;
(v) the reduction or increase in the
prevalence of substance use disorders;
(vi) inflammation;
(vii) sleep quality;
(viii) agitation;
(ix) quality of life;
(x) exacerbated or new mental health
conditions; and
(xi) suicidal ideation.
(B) with respect to covered veterans diagnosed with
post-traumatic stress disorder, an evaluation of the
effects of the use of cannabis on--
(i) the symptoms of post-traumatic stress
disorder (PTSD) as established by or derived
from the clinician administered PTSD scale, the
PTSD checklist, the PTSD symptom scale, the
post-traumatic diagnostic scale, and other
applicable methods of evaluating symptoms of
post-traumatic stress disorder;
(ii) the reduction or increase in
benzodiazepine use or dosage;
(iii) the reduction or increase in alcohol
use;
(iv) the reduction or increase in the
prevalence of substance use disorders;
(v) mood;
(vi) anxiety;
(vii) social functioning;
(viii) agitation;
(ix) suicidal ideation; and
(x) sleep quality, including frequency of
nightmares and night terrors.
(3) Optional elements.--The clinical trials required by
paragraph (1) may include, as appropriate, an evaluation of the
effects of the use of cannabis to treat chronic pain and post-
traumatic stress disorder on other symptoms, clinical outcomes,
and conditions not covered by paragraph (2), which may
include--
(A) pulmonary function;
(B) cardiovascular events;
(C) head, neck, and oral cancer;
(D) testicular cancer;
(E) ovarian cancer;
(F) transitional cell cancer;
(G) intestinal inflammation;
(H) motor vehicle accidents; or
(I) spasticity.
(b) Long-Term Observational Study.--The Secretary may carry out a
long-term observational study of the participants in the clinical
trials required by subsection (a).
(c) Type of Cannabis.--
(1) In general.--In carrying out the clinical trials
required by subsection (a), the Secretary shall study varying
forms of cannabis, including whole plant raw material and
extracts, and may study varying routes of administration.
(2) Plant cultivars.--Of the varying forms of cannabis
required under paragraph (1), the Secretary shall study plant
cultivars with varying ratios of tetrahydrocannabinol to
cannabidiol.
(d) Implementation.--Not later than 18 months after the date of the
enactment of this Act, the Secretary shall--
(1) develop a plan to implement this section and submit
such plan to the Committee on Veterans' Affairs of the Senate
and the Committee on Veterans' Affairs of the House of
Representatives; and
(2) issue any requests for proposals the Secretary
determines appropriate for such implementation.
(e) Termination of Clinical Trials.--
(1) Clinical guideline requirements or excessive risk.--The
Secretary may terminate the clinical trials required by
subsection (a) if the Secretary determines that the Department
of Veterans Affairs is unable to meet clinical guideline
requirements necessary to conduct such trials or the clinical
trials would create excessive risk to participants.
(2) Completion upon submittal of final report.--The
Secretary may terminate the clinical trials required by
subsection (a) upon submittal of the final report required
under subsection (f)(2).
(f) Reports.--
(1) Periodic reports.--During the five-year period
beginning on the date of the commencement of clinical trials
required by subsection (a), the Secretary shall submit
periodically, but not less frequently than annually, to the
Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives reports on
the implementation of this section.
(2) Final report.--Not later than one year after the
completion of the five-year period specified in paragraph (1),
the Secretary shall submit to the Committee on Veterans'
Affairs of the Senate and the Committee on Veterans' Affairs of
the House of Representatives a final report on the
implementation of this section.
SEC. 5. ADMINISTRATION OF STUDY AND CLINICAL TRIALS.
(a) Demographic Representation.--In carrying out the study required
by section 3 and the clinical trials required by section 4, the
Secretary shall ensure representation in such study and trials of
demographics that represent the population of veterans in the United
States, as determined by the most recently available data from the
American Community Survey of the Bureau of the Census.
(b) Data Preservation.--The Secretary shall ensure that the study
required by section 3 and the clinical trials required by section 4
include a mechanism to ensure--
(1) the preservation of all data, including all data sets
and survey results, collected or used for purposes of such
study and trials in a manner that will facilitate further
research; and
(2) registration of such data in the database of privately
and publicly funded clinical studies maintained by the National
Library of Medicine (or successor database).
(c) Anonymous Data.--The Secretary shall ensure that data relating
to any study or clinical trial conducted under this Act is anonymized
and cannot be traced back to an individual patient.
(d) Effect on Other Benefits.--The eligibility or entitlement of a
covered veteran to any other benefit under the laws administered by the
Secretary or any other provision of law shall not be affected by the
participation of the covered veteran in the study under section 3, a
clinical trial under section 4(a), or a study under section 4(b).
(e) Effect on Other Laws.--Nothing in this Act shall affect or
modify--
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C.
262); or
(3) the authority of the Commissioner of Food and Drugs and
the Secretary of Health and Human Services--
(A) under--
(i) the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.); or
(ii) section 351 of the Public Health
Service Act (42 U.S.C. 262); or
(B) to promulgate Federal regulations and
guidelines pertaining to cannabidiol, marijuana, or
other subject matter addressed in this Act.
Calendar No. 32
118th CONGRESS
1st Session
S. 326
_______________________________________________________________________
A BILL
To direct the Secretary of Veterans Affairs to carry out a study and
clinical trials on the effects of cannabis on certain health outcomes
of veterans with chronic pain and post-traumatic stress disorder, and
for other purposes.
_______________________________________________________________________
March 23, 2023
Reported without amendment