Pennsylvania Statutes Title 35 P.S. Health and Safety § 10232.2. Legislative findings and intent

(1) The process of approval for investigational drugs, biological products and medical devices in the United States by the Food and Drug Administration protects future patients from premature, ineffective and unsafe medications and treatments over the long run, but the process often takes many years.

(2) Patients who have a terminal illness do not have the luxury of waiting until an investigational drug, biological product or medical device receives final approval from the Food and Drug Administration.

(3) Patients who have a terminal illness should be allowed to attempt to pursue the preservation of their lives by accessing available investigational drugs, biological products and medical devices.

(4) The use of available investigational drugs, biological products and medical devices is a decision that should be made by the patient with a terminal illness in consultation with the patient's treating physician and the patient's health care team, if applicable.

(5) The decision to use an investigational drug, biological product or medical device should be made with full awareness of the potential risks, benefits and consequences to the patient and the patient's family.

(6) The Food and Drug Administration recently, in June 2016, implemented a more streamlined process for individual patient access to investigational drugs and biological products through its Individual Patient Expanded Access program -- Form FDA 3926, which may be useful in some situations.