RAP-C: Stalling California Psychedelic Studies

The TDR Three Key Takeaways:

1. RAP-C (Research Advisory Panel of California) is causing significant delays in psychedelic and addiction treatment research due to a halt in its operations and a backlog in study approvals.

2. The panel’s requirement for public meetings and perceived redundancy in the review process are major points of contention, prompting calls for its dissolution.

3. The impasse poses a risk to California’s status in medical research, potentially hindering scientific advancements and the development of new treatment options.

In California, a significant number of studies on psychedelics and addiction treatment are currently stalled. This delay is attributed to the Research Advisory Panel of California (RAP-C), a state-established entity responsible for reviewing research involving federally restricted drugs and addiction treatment. Originally created to ensure safe and legal research practices, RAP-C now faces scrutiny and calls for dissolution due to its perceived redundancy and the delays it causes in vital research.

The panel, which includes representatives from state agencies and universities, has the authority to approve, monitor, or reject research studies. However, the panel’s operations have been halted since the fall, with meetings scheduled for October and December being canceled without much explanation. This pause has left numerous studies, some of which investigate the potential of psychedelics to treat conditions like PTSD, depression, and substance use disorder, in limbo.

One of the primary concerns is the backlog of studies awaiting review. By December, 33 new proposals and 13 amendments to existing research were pending, causing significant delays. Organizations like the Alexander Shulgin Research Institute, Stanford University, Compass, MAPS and Mind Medicine experienced delays having to use this process. Researchers express frustration, arguing that the panel, even when functional, duplicates the vetting process already conducted by other regulatory bodies such as the FDA and the DEA. They contend that the state panel’s review is redundant and unnecessarily prolongs the initiation of crucial studies.

While some researchers acknowledge the panel’s role in ensuring safe and legal research practices, the prevalent sentiment is that its operations are outdated. The panel’s requirement for public meetings, as per state law, further complicates matters, especially with recent changes or interpretations of the Bagley-Keene Open Meeting Act. This requirement is seen as a deterrent for pharmaceutical companies and researchers concerned about the confidentiality of their intellectual property and study details.

The situation in California is particularly noteworthy given that the state hosts the highest number of clinical trials in the U.S., yet it is the only one with such a panel. The current impasse not only hampers the progress of research within the state but also potentially disadvantages California in the broader field of medical research, as studies can be initiated more swiftly in other states without such bureaucratic hurdles.

In response to these challenges, a newly formed consortium of researchers is advocating for the elimination of the panel. They argue that the rigorous scrutiny already provided by institutions like the FDA and the National Institutes of Health renders the state panel obsolete. This sentiment is echoed by various professionals in the field, who question the necessity of additional state-level scrutiny when federal agencies are already ensuring the safety and efficacy of research studies.

The situation represents a critical juncture for research in California, highlighting the need for a balance between regulatory oversight and the facilitation of scientific advancements, particularly in the promising field of psychedelic research and addiction treatment. The resolution of this impasse and reconsideration of the panel’s role could have significant implications for the future of medical research and treatment options available to Californians and the broader scientific community.