Signed by Governor Doug Ducey

Vote Smart's Synopsis:

Vote to pass a bill that expands healthcare options for individuals with terminal illness/disease to try certain experimental treatment options.

Highlights:

• Authorizes manufacturers operating within an eligible facility to treat eligible patients an individualizes ivenstigational treatment, drug, or biological product or device (Sec. 1).

• Defines “eligible facility” as a health care institution that operaties under a federalwide assurance for protection of human subjects and subject to federalwide assurance regulations, policies, and guidelines, including renewals or updates (Sec. 1).

• Defines “eligible patient” as a patient who meets all of the following conditions, including (Sec. 1):

• Has a life-threatening disease or condition, or a severly debiliating illness, as attested to by their physician;

• Has considered all other treatment options currently approved by the USFDA;

• Has received a recommendation from their physician for an individualized investigational treatment based on analysis;

• Has given written informed consent for the use of the individualzed investigational drug, biolagical product or device;

• Has documentation from their physician that proves these requirements.

• Defines “individualized investigational treatment” as a drug, biological product or device that is unique to and produced exclusively for use by an individual patient based on their genetic profile, and includes individualized gene therapy, antisense oligonucleotides and individualized neoantigen vaccines (Sec. 1).

• Defines “ life-threatening disease or condition” as a diesease or condition that has the likelihood of death unless the course of the disease or condition is interrupted, or has a potentially fatal outcome for which the end point of clinical trial analysis is survival (Sec. 1).

• Defines “severely debilitating illness” as a disease or condition that causes major irreversible morbidity (Sec. 1).

Full Bill Text

Vote Smart's Synopsis:

Vote to pass a bill that expands healthcare options for individuals with terminal illness/disease to try certain experimental treatment options.

Highlights:

• Authorizes manufacturers operating within an eligible facility to treat eligible patients an individualizes ivenstigational treatment, drug, or biological product or device (Sec. 1).

• Defines “eligible facility” as a health care institution that operaties under a federalwide assurance for protection of human subjects and subject to federalwide assurance regulations, policies, and guidelines, including renewals or updates (Sec. 1).

• Defines “eligible patient” as a patient who meets all of the following conditions, including (Sec. 1):

• Has a life-threatening disease or condition, or a severly debiliating illness, as attested to by their physician;

• Has considered all other treatment options currently approved by the USFDA;

• Has received a recommendation from their physician for an individualized investigational treatment based on analysis;

• Has given written informed consent for the use of the individualzed investigational drug, biolagical product or device;

• Has documentation from their physician that proves these requirements.

• Defines “individualized investigational treatment” as a drug, biological product or device that is unique to and produced exclusively for use by an individual patient based on their genetic profile, and includes individualized gene therapy, antisense oligonucleotides and individualized neoantigen vaccines (Sec. 1).

• Defines “ life-threatening disease or condition” as a diesease or condition that has the likelihood of death unless the course of the disease or condition is interrupted, or has a potentially fatal outcome for which the end point of clinical trial analysis is survival (Sec. 1).

• Defines “severely debilitating illness” as a disease or condition that causes major irreversible morbidity (Sec. 1).

Full Bill Text