Signed by Governor Tom Wolf

Vote Smart's Synopsis:

Vote to pass a bill that authorizes the use of investigational drugs, biological products and medical devices by eligible patients.

Highlights:

• 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).

Full Bill Text