Bill Summary for H 727 (2023-2024)

Printer-friendly: Click to view

Summary date: 

Apr 19 2023

Bill Information:

View NCGA Bill Details2023-2024 Session
House Bill 727 (Public) Filed Tuesday, April 18, 2023
Intro. by Sasser, Autry, Chesser, Goodwin.

View: All Summaries for BillTracking:

Bill summary

Establishes the Breakthrough Therapies Research (BTR) Grant Fund as a nonreverting special fund in the Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Abuse Services (DHHS; Division). Directs that funds be used to award two competitive BTR Grants of $2.5 million each, by July 1, 2024, to recipients for eligible research projects or studies to pay for associated costs. Requires the Division to grant awards by August 1, 2024. Limits applicants to federal medical or research entities and academic institutions located in the State with infrastructure and staff experience to support the funded research. Requires research to be conducted in the State and all participants to be at least 21. Requires applicants to attest that funds will be used to conduct research on the use of one of two psychedelics, MDMA and psilocybin, and comply with FDA protocols and federal law. Establishes specific parameters for research involving MDMA, including concentrating on the treatment of PTSD within specified disproportionately impacted populations, including military veterans, first responders, frontline healthcare personnel, and domestic violence or sexual assault survivors. Establishes specific parameters for research involving psilocybin, including concentrating on the treatment of anxiety and depressive disorders. Requires all studies to measure participant base pain levels and any changes that may be related to breakthrough therapies, defined as any drug that has been designated as such for which an expedited approval pathway has been granted by the FDA. Requires grant recipients to report to the Division and the BTR Advisory Board, as established, by January 15, 2028. Specifies that the grant amount is intended to fund three years of research study. Directs the Division to announce the recipients and report to the specified NCGA committee by July 1, 2024. Details required content of the report with respect to award recipients and their research projects or studies. Directs the Division to adopt any necessary implementing rules, and to determine the method any manner to be used for grant applications. 

Establishes the Breakthrough Therapies Research Advisory Board (BTR Advisory Board) within the Division, consisting of 13 members appointed as specified, with members appointed by the Governor or the NCGA, or serving on the Board by way of office held, or by designation by a named officer. Details appointed member qualifications, including professional licensing and experience requirements, and specifies that the BTR Advisory Board is intended to provide statewide geographic representation that is balanced and diverse. Requires initial appointments by December 1, 2023, with vacancies occurring thereafter filled in the same manner of appointment. Enumerates five duties of the BTR Advisory Board, including (1) reviewing grant applications and making recommendations to the Division regarding research projects or studies to be funded, (2) annually reporting to the Division, beginning by December 1, 2024, any updated based on its monitoring of the grant projects or studies, and (3) submitting a report to the Division evaluating the research findings and recommendations submitted by the grant recipients, by December 1, 2028, along with any recommendations for continuation of the pilot. Sunsets these provisions on December 31, 2028.

Effective July 1, 2023, appropriates $5.4 million from the General Fund to the Division for 2023-25. Requires $5 million to be deposited into the BTR Grant Fund, and $400,000 to be used by the Division for administrative costs of the pilot program, including costs of the BTR Advisory Board.