AK SB19

Physicians cannot be disciplined by the board for prescribing, dispensing, or administering investigational drugs, biological products, or devices to terminally ill patients who are ineligible for clinical trials, have considered all FDA-approved treatment options, and provide written informed consent.

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

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

Physicians, medical team members, manufacturers, importers, and distributors are granted civil immunity from liability for injury or death resulting from investigational drug use if acting in good faith with reasonable care and providing proper informed consent and notice.

Licensed health care facilities cannot be required to increase services solely to accommodate physicians' practice of prescribing investigational drugs to patients.