(a) A manufacturer of an investigational drug, biological product, or device may:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or
(2)
(A) Require an eligible patient to pay the costs associated with the manufacture of the investigational drug, biological product, or device.
(B) As used in this section, “costs associated with the manufacture of the investigational drug, biological product, or device” means the actual out-of-pocket costs incurred in providing the investigational drug, biological product, or device to the patient in the specific case.
(b) If a patient dies while being treated by an investigational drug, biological product, or device, the patient's heirs are not liable for any outstanding debt to the manufacturer related to the investigational drug, biological product, or device.