AB 1668 Summary

• Establishes the "Right to Try Act" allowing manufacturers to provide investigational drugs, biological products, and devices to eligible patients with immediately life-threatening diseases or conditions that have completed Phase 1 clinical trials but lack FDA approval for general use.

• Defines "eligible patients" as those who have exhausted FDA-approved treatment options, cannot access nearby clinical trials within one week, and have written recommendations from both a primary physician and consulting physician, plus informed written consent.

• Prohibits the Medical Board of California and Osteopathic Medical Board of California from disciplining physicians who recommend or prescribe investigational treatments consistent with institutional review board-approved protocols.

• Authorizes (but does not require) health benefit plans to provide coverage for investigational drugs and associated costs, while clarifying patients remain liable for treatment expenses unless otherwise covered by their plan or manufacturer agreement.

• Requires institutional review boards to submit biannual reports on investigational drug requests, treatment outcomes, and adverse events to state health agencies, and protects manufacturers from civil and criminal liability unless they fail to exercise reasonable care.