This bill — known as the Right to Try Act — would allow the use of experimental drugs, biological products, and devices that haven’t been approved by the Food and Drug Administration (FDA) by patients diagnosed with a terminal illness in accordance with state laws.
A physician would be required to make several certifications before a patient could receive experimental drugs, including:
That the physician is in good standing with professional certifying organizations and has personally examined the patient.
That there is no reason to conclude the experimental treatment poses an unreasonable and significant risk of danger to the patient.
That the patient has been diagnosed with a terminal illness and doesn’t have treatment options that are comparable to the experimental treatment and are approved by the FDA.
That the probable risk to the patient from the treatment isn’t greater than the probable risk from the patient’s disease or condition.
That the physician has provided the patient with a written statement and oral explanation of the medical treatment.
The patient would also have to acknowledge that the physician has disclosed:
The treatment is experimental or non-conventional.
That the treatment hasn’t been approved by the FDA.
The material risks generally recognized by a reasonably prudent physician of the medical treatment’s side effects.
An explanation of the medical treatment, including the expected frequency and duration of the treatment.
No producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental treatment could be held liable for providing or using the treatment. No outcome of the treatment could be used by a federal agency reviewing the treatment to delay or otherwise adversely impact the review or approval of the experimental treatment.