2025 SESSION
INTRODUCED
25103527D
SENATE BILL NO. 1101
Offered January 8, 2025
Prefiled January 7, 2025
A BILL to amend the Code of Virginia by adding in Chapter 2 of Title 32.1 an article numbered 23, consisting of sections numbered 32.1-73.28 through 32.1-73.31, relating to the Breakthrough Therapies for Veteran Suicide Prevention Act.
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Patrons—Hashmi, Boysko, Mulchi, Perry and Srinivasan; Delegate: Feggans
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Referred to Committee on Education and Health
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Be it enacted by the General Assembly of Virginia:
1. That the Code of Virginia is amended by adding in Chapter 2 of Title 32.1 an article numbered 23, consisting of sections numbered 32.1-73.28 through 32.1-73.31, as follows:
Article 23.
Breakthrough Therapies for Veteran Suicide Prevention Act.
§ 32.1-73.28. Definitions.
As used in this article:
"Council" means the Breakthrough Therapies for Veteran Suicide Prevention Advisory Council.
"Compassionate use" means treating patients suffering from terminal or life-threatening conditions, including treatment-resistant mental health conditions, under either the federal Right to Try Act (P.L. 115-176) or U.S. Food and Drug Administration's expanded access program (21 U.S.C. § 360bbb(b)).
"FDA Breakthrough Therapies" means investigational drugs that have been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) under § 506(a) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)).
"Fund" means the Breakthrough Therapies for Veteran Suicide Prevention Fund.
"Veteran" means a former member of the following entities who was discharged from active duty:
1. The Armed Forces of the United States;
2. A reserve component of the Armed Forces of the United States; or
3. The National Guard of any state.
§ 32.1-73.29. Breakthrough Therapies for Veteran Suicide Prevention Fund.
A. There is hereby created in the state treasury a special nonreverting fund to be known as the Breakthrough Therapies for Veteran Suicide Prevention Fund within the Department of Health. The Fund shall be established on the books of the Comptroller. All funds appropriated for such purpose and any gifts, donations, grants, bequests, and other funds received on its behalf shall be paid into the state treasury and credited to the Fund. Interest earned on moneys in the Fund shall remain in the Fund and be credited to it. Any moneys remaining in the Fund, including interest thereon, at the end of each fiscal year shall not revert to the general fund but shall remain in the Fund. Moneys in the Fund shall be used solely for the purposes of providing an annual and perpetual source of funding to support clinical research and implementation of FDA Breakthrough Therapies for the treatment of post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), major depressive disorder (MDD), or traumatic brain injury (TBI), which are conditions that disproportionately impact veterans and significantly increase the risk of suicide. Expenditures and disbursements from the Fund shall be made by the State Treasurer on warrants issued by the Comptroller upon written request signed by the State Health Commissioner.
B. The appropriated funds shall be used for any of the following activities consistent with the purpose of the Fund under subsection A:
1. Establishing public-private partnerships to jointly fund Phase III clinical trials of FDA Breakthrough Therapies;
2. Investigator-initiated clinical trials, including for the following purposes:
a. Informing optimal methods of treatment delivery for FDA Breakthrough Therapies; and
b. Informing safety and efficacy of FDA Breakthrough Therapies to treat patients with conditions frequently comorbid with PTSD, TRD, MDD, or TBI.
3. Establishing a compassionate use program, including data collection and analysis;
4. Education and training opportunities for mental health professionals;
5. Patient access pilot programs, including real-world data collection and analysis; and
6. Implementation studies, including research and analyses of best practices, cost-effectiveness, and methods to reduce treatment costs.
§ 32.1-73.30. Breakthrough Therapies for Veteran Suicide Prevention Advisory Council established; membership; duties.
A. There is created within the Department of Health the Breakthrough Therapies for Veteran Suicide Prevention Advisory Council (the Council). The Council shall consist of six members, to be appointed as follows:
1. Two members to be appointed by the Governor;
2. Two members of the House of Delegates to be appointed by the Speaker of the House of Delegates in accordance with the principles of proportional representation contained in the Rules of the House of Delegates; and
3. Two members of the Senate, one of whom shall represent the majority party and one of whom shall represent the minority party, to be appointed by the Senate Committee on Rules.
B. The Council shall include members with a mix of expertise or experience in clinical research or treatment of patients suffering from PTSD, TRD, MDD, TBI, suicidal ideation, veteran mental and behavioral health care, public health, and FDA Breakthrough Therapies research.
C. The Council shall assist and advise the Department on the administration of grant funding or contracting to carry out the Fund's purpose and activities supported pursuant to § 32.1-73.29.
§ 32.1-73.31. Board of Pharmacy; designated, rescheduled, and descheduled controlled substances.
If any FDA Breakthrough Therapy is designated, rescheduled, or descheduled as a controlled substance under federal law and notice of such action is given to the Board of Pharmacy, the Board of Pharmacy shall similarly control the substance under § 54.1-3443 after the expiration of 30 days from publication in the Federal Register of a final or interim final order or rule designating a substance as a controlled substance or rescheduling or descheduling a substance by amending its regulations in accordance with the requirements of Article 2 (§ 2.2-4006 et seq.) of the Administrative Process Act.
2. That appointments to the Breakthrough Therapies for Veteran Suicide Prevention Advisory Council shall be made within 60 days of the enactment of this act.
3. That the Breakthrough Therapies for Veteran Suicide Prevention Advisory Council shall make recommendations on the use of the Breakthrough Therapies for Veteran Suicide Prevention Fund pursuant to this act within 120 days of enactment of this act.
4. That the Department of Health shall award funds under this act within 180 days of funds becoming available, and such funds shall remain available until expended.
5. That the Department of Health shall report findings and recommendations from studies funded by the Breakthrough Therapies for Veteran Suicide Prevention Fund to the Governor and the General Assembly on or before December 1, 2026.