Controlled substances: research.
Vote required
Majority
Fiscal committee
No
Appropriation
No
Current location
Appropriations
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Assembly
- Passed Senate
- To Governor
- Became Law
Overview
This bill, the California Veterans’ Right to Try Act, aims to allow the Research Advisory Panel to request FDA approval for clinical trials of Schedule I and Schedule II controlled substances, specifically focusing on psychedelic compounds, to study their efficacy in treating mental health conditions common among veterans. It prioritizes research involving veterans diagnosed with two or more severe mental health conditions and ineligible for standard FDA trials. The bill includes provisions for expedited approval if the FDA doesn't respond promptly and requires independent peer review of the research protocol to ensure scientific rigor.
Key provisions
- Authorizes the Research Advisory Panel to submit Investigational New Drug (IND) applications to the FDA for clinical trials of Schedule I and Schedule II controlled substances.
- Prioritizes research involving veterans with two or more severe mental health conditions and who are ineligible for FDA-approved trials.
- Provides for expedited approval if the FDA does not timely approve an IND application.
- Requires independent peer review of the research protocol by specified entities.
- Specifies criteria for the research projects, including a focus on psilocybin, ibogaine, or other approved substances.
- Establishes a timeframe for the bill's effectiveness, ending on January 1, 2028.
- Allows state public hospitals and research institutions to conduct the research in compliance with state law.
- Requires approval from an Institutional Review Board (IRB) to ensure ethical research practices.
Bill text
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Sponsors
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4 on record
Primary sponsor
Cosponsors
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