Dan Frankel Co-Sponsored (Introduced) this Legislation.
Title: Authorizes Terminally Ill Patients to Use Experimental Treatments
Signed by Governor Tom Wolf
Title: Authorizes Terminally Ill Patients to Use Experimental Treatments
Title: Authorizes Terminally Ill Patients to Use Experimental Treatments
Vote to pass a bill that authorizes the use of investigational drugs, biological products and medical devices by eligible patients.
Authorizes drug manufacturers to provide an investigational drug, biological product, or medical device to an eligible patient either free of charge or in exchange for payment (Sec. 4).
Defines “eligible patient” as an individual who has met all of the following requirements (Sec. 3):
Has a terminal illness attested to by their physician;
Has been unable to participate in a clinical trial within 100 miles of their residence;
Has received a recommendation from their physician for an investigational drug, biological product, or medical device;
Has carefully considered all FDA approved treatment options;
Has given written, informed consent for use of the investigational drug, biological product, or medical device;
Has documentation from their physician that they meet the above requirements; and
Is not being treated as an inpatient in any hospital.
Defines “terminal illness” as a disease or condition that will soon result in death without life-sustaining procedures (Sec. 3).
Defines “investigational drug, biological product, or medical device” as a product that has successfully complete phase one of a clinical trial but has not been approved for general use by the FDA (Sec. 3).
Defines “written, informed consent” as a document signed by the patient and attested to by a physician and a witness that contains information including, but not limited to, the following (Sec. 3):
Clear identification of the specific investigational drug, biological product, or medical device the patient is seeking to use;
Description of the potentially best and worse outcomes of the treatment;
Information making clear that the patient’s insurer is not obligated to pay for the treatment; and
Indication that the patient may not be eligible for hospice care after treatment begins.
Specifies that healthcare providers may not be subject to criminal or civil liability, or be found to have committed unprofessional conduct, based on a recommendation for the use of an investigational drug, biological product, or medical device (Sec. 5).
Prohibits licensure boards from suspending or revoking a healthcare provider’s license based solely on such provider’s recommendation of an investigational drug, biological product, or medical device to an eligible patient (Sec. 5).
Title: Authorizes Terminally Ill Patients to Use Experimental Treatments
Title: Authorizes Terminally Ill Patients to Use Experimental Treatments