Assigned to HHS FOR COMMITTEE
ARIZONA STATE SENATE
Fifty-Fifth Legislature, Second Regular Session
FACT SHEET FOR S.B. 1163
individualized investigational treatment; availability; prohibitions
Purpose
Allows eligible manufacturers to make individualized investigational treatment (IIT)
available to patients with a life threating disease or severely debilitating illness, including
individualized gene therapy or any drug, biological product or device produced specifically for the
patient's own genetic profile.
Background
Before a drug manufacturer can market a drug in the United States, the drug must first be
tested and approved by the Food and Drug Administration (FDA). After a manufacturer tests a
drug in a laboratory to determine its effectiveness and likelihood of safe outcomes in humans, the
manufacturer submits an Investigational New Drug application to the FDA for review. The drug
then goes through three phases of clinical trials in humans after which, the manufacturer sends the
data to the FDA for review by experts including chemists, physicians, statisticians,
pharmacologists and other scientists. While the drug is being studied in a clinical trial it is called
an investigational drug. If it is determined that the drug’s benefits outweigh the risks for the
proposed use, the drug is approved for sale (FDA).
In 2014, Arizona voters approved the Terminal Patients' Right to Try Act to allow
manufacturers, health care institutions and physicians to make investigational drugs, biological
products and devices that have completed phase one of a clinical trial but have not been FDA-
approved available to eligible patients that have: 1) a terminal illness; 2) no comparable or
satisfactory FDA-approved treatment options available; 3) received a prescription or
recommendation from a physician; 4) provided written consent for use of the investigational drug,
biological or device; and 5) received documentation from a physician that each of these
requirements are met. The patient's physician must determine that the probable risk to the patient
from the medication or treatment is not greater than the probable risk from the disease or condition
prior to recommending the medication or treatment (AZSOS).
Human gene therapy is the modification or manipulation of the expression of a gene or the
alteration of the biological properties of living cells for therapeutic use to treat or cure disease,
including cancer, genetic diseases and infectious diseases (FDA).
There is no anticipated fiscal impact to the state General Fund associated with this
legislation.
Provisions
1. Permits manufacturers operating within an eligible facility to make IIT available to eligible
patients including individualized gene therapy, antisense oligonucleotides, individualized
neoantigen vaccines or any drug, biological product or device produced specifically for the
patient's own genetic profile. FACT SHEET
S.B. 1163
Page 2
2. Allows an eligible patient's physician to request an individualized investigational drug,
biological product or device from an eligible manufacturer.
3. Specifies manufacturers are not required to make IIT available to patients.
4. Permits an eligible facility or manufacturer to:
a) provide IIT to a patient without receiving compensation; and
b) require an eligible patient to pay the cost of manufacturing IIT.
5. Specifies a health plan, third party administrator or other third-party payor may, but is not
required to, provide coverage for the cost of IIT.
6. States hospitals and other health care institutions are not required to provide any new or
additional services associated with IIT, unless approved by the institution.
7. Specifies that the heirs of a patient that dies while receiving IIT are not liable for any
outstanding debt related to the treatment.
8. Prohibits a health profession regulatory board from revoking, failing to renew, suspending or
taking any other action against a physician's license for recommending IIT to an eligible
patient.
9. Restricts an official, employee or agent of the state from blocking an eligible patient's access
to IIT.
10. Specifies that counseling, providing advice or recommendations consistent with medical
standards is not considered blocking a patient's access to IIT.
11. Specifies this legislation does not create a private cause of action against an IIT manufacturer
or any other person involved in the care of a patient receiving IIT for any patient harm resulting
from IIT if the manufacturer or person is complying with the law in good faith and has
exercised reasonable care.
12. Defines eligible facility, eligible patient, individualized investigational treatment, severely
debilitating illness and written informed consent.
13. Becomes effective on the general effective date.
Prepared by Senate Research
January 31, 2022
MM/sr