Controlled substances: research.

Plain English Breakdown

The official source material does not specify the exact criteria for expedited approval beyond requiring an independent peer review of scientific merit and rigor.

Research on Controlled Substances for Veterans

AB-2489 allows the Research Advisory Panel to submit investigational new drug applications for Schedule I or II controlled substances to study their effects on veterans with severe mental health conditions.

What This Bill Does

• Allows the Research Advisory Panel to apply to the FDA for clinical trials of certain controlled substances for research purposes.
• Permits expedited approval by the panel if the FDA does not approve an application in a timely manner, provided it meets specific criteria.

Who It Names or Affects

• Veterans who meet certain medical criteria can participate in research studies involving controlled substances.
• The Research Advisory Panel will manage the application process and expedited approval if needed.

Terms To Know

Schedule I or II Controlled Substances

Drugs that are highly regulated due to their potential for abuse and lack of accepted medical use, such as certain hallucinogenic drugs.

Investigational New Drug Application (IND)

A request submitted by a researcher to the FDA to begin clinical trials on an experimental drug or biological product.

Limits and Unknowns

• The bill's provisions are set to expire in January 2032.
• It is unclear how many veterans will qualify and participate in these studies.

Official Summary Text

AB 2489, as amended, Lowenthal.
Controlled substances: research.
Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances in Schedule V. Existing law creates the Research Advisory Panel, as specified, to conduct hearings on, and in other ways study, research projects concerning controlled substances. Existing law authorizes the panel to approve research projects that have been registered with the Attorney General concerning the nature and effects of cannabis or hallucinogenic drugs and the treatment of abuse of controlled substances. Existing law authorizes a person who, under federal law, is entitled to use controlled substances for the purpose of research, instruction, or analysis to lawfully
obtain and use those controlled substances upon approval by the panel, as specified.
This bill, the California Veterans’ Right to Try Act, would, until January 1,
2028,
2032,
authorize the Research Advisory Panel to submit an investigational new drug application to the United States Food and Drug Administration requesting approval for a clinical trial of Schedule I or Schedule II controlled
substances, as specified. The bill would authorize the Research Advisory Panel to, upon the failure of the United States Food and Drug Administration to timely approve an application, provide expedited approval of the research project if the application meets certain requirements, including proof of an independent peer review of the study for scientific merit and rigor by certain entities. The bill would require a veteran, in order to participate, to have been diagnosed with 2 or more severe or life-threatening mental health conditions and have been deemed ineligible to participate in United
States Food and Drug Administration approved trials.
substances to study the administration and efficacy of those compounds among a patient pool comprised exclusively of veteran subjects with comorbidities that commonly overlap with the incidence of suicidality among veterans.
This bill would make
conforming
technical
changes and would make related findings and declarations.

Current Bill Text

Download Bill PDF