CA SB149

Permits manufacturers of investigational drugs, biological products, or devices to make them available to patients with immediately life-threatening diseases or conditions that have no comparable FDA-approved treatment options available.

Requires eligible patients to obtain written informed consent approved by an institutional review board, which must disclose potential risks, best and worst outcomes, and that patients are liable for all expenses unless covered by their health benefit plan.

Prohibits the Medical Board of California and Osteopathic Medical Board of California from disciplining physicians based solely on recommending, prescribing, or treating eligible patients with investigational drugs if the recommendation is consistent with an approved institutional review board protocol.

Allows manufacturers to provide investigational drugs at no cost, charge patients for manufacturing costs, or require participation in data collection, but does not require health benefit plans or state agencies to provide coverage.

Requires institutional review boards to biannually report to the State Department of Public Health, Medical Board of California, and Osteopathic Medical Board of California regarding number of requests, approvals, treatment duration, adverse events, and patient outcomes.