AK SB113

Physicians cannot face disciplinary action for prescribing, dispensing, or administering investigational drugs, biological products, or devices to terminally ill patients who meet specific criteria including ineligibility for clinical trials and consideration of FDA-approved treatment options.

Investigational drugs, biological products, or devices are defined as those that have completed Phase 1 studies and are in ongoing Phase 2 or Phase 3 clinical trials but have not received FDA approval for general use.

Terminal illness is defined as a disease that without life-sustaining procedures will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.

Physicians, medical team members, manufacturers, importers, and distributors are granted liability immunity for patient injury or death resulting from investigational drug use if they act in good faith with reasonable care and obtain written informed consent after disclosing all FDA-approved treatment options.

Licensed healthcare facilities cannot be required to increase services solely to accommodate physicians' practice of prescribing investigational drugs, and existing drug enforcement statutes do not apply to physicians following the conditions established in this act.