VA Medicinal Cannabis Research Act of 2023

Subjects: Armed Forces and National Security, Alternative treatments, Congressional oversight, Drug trafficking and controlled substances, Government studies and investigations, Health information and medical records, Medical research, Mental health, Neurological disorders, Veterans' medical care

Summary:  <p><b>VA Medicinal Cannabis Research Act of 2023</b></p> <p>This bill requires the Department of Veterans Affairs (VA) to study the effects of cannabis on veterans who are enrolled in the VA health care system and have been diagnosed with post-traumatic stress disorder (PTSD) or chronic pain (i.e., eligible veterans).</p> <p>First, the bill requires the VA to conduct an observational, 18-month study on the effects of cannabis on the health outcomes of eligible veterans. The VA must report on the study and address whether it is able to meet criteria necessary to conduct clinical trials.</p> <p>Then, if the VA determines that it is able to proceed, it must carry out a series of clinical trials on the effects of cannabis appropriate for investigational use, as determined by the Food and Drug Administration, on the outcomes of eligible veterans. The VA must carry out a long-term observational study of the clinical trial participants.</p> <p>The VA may terminate the trials if it is unable to meet clinical guideline requirements or the trials would create excessive risk to participants.</p> <p>The VA must ensure that the study and trials are representative of the demographics of veterans in the United States, as determined by the most recent data from the American Community Survey of the Bureau of the Census.</p> <p>The study and trials must include mechanisms to ensure data preservation and registration as necessary (in an anonymous form).</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 326 Introduced in Senate (IS)]

&lt;DOC&gt;






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 and Mr. Sullivan) introduced the following 
 bill; which was read twice and referred to the Committee on Veterans' 
                                Affairs

_______________________________________________________________________

                                 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.
                                 &lt;all&gt;
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