Vote Smart's Synopsis:

Vote to pass a resolution that submits to the voter a question that authorizes a manufacturer to provide an investigational drug, biological product, or device to eligible patients.

Highlights:

• Defines “investigational drug, biological product, or device” as a treatment that has successfully completed phase 1 of a clinical trial, but has not been approved for general use by the Food and Drug Administration (Sec. 1).

• Defines “eligible patient” as an individual who meets certain criteria, including, but not limited to, the following (Sec. 1):
• The individual has a terminal illness as determined by their physician and a consulting physician;
• The individual’s physician has determined that there is no satisfactory or comparable Food and Drug Administration approved treatment; and
• The individual has received a recommendation from their physician for the investigational treatment.

• Authorizes a manufacturer to require an individual to pay for investigational treatment and to participate in data collection relating to the treatment (Sec. 1).

• Specifies that a health care insurer or any state agency does not have to provide coverage for the cost of the investigational treatment (Sec. 1).

• Prohibits any state regulatory board from revoking or failing to renew a physician’s license based on the physician’s recommendation of an investigational treatment (Sec. 1).

• Specifies that any official, employee, or agent of the state who blocks an eligible patient’s access to an investigational treatment is guilty of a class 1 misdemeanor (Sec. 1).

Full Bill Text

Vote Smart's Synopsis:

Vote to pass a resolution that submits to the voter a question that authorizes a manufacturer to provide an investigational drug, biological product, or device to eligible patients.

Highlights:

• Defines “investigational drug, biological product, or device” as a treatment that has successfully completed phase 1 of a clinical trial, but has not been approved for general use by the Food and Drug Administration (Sec. 1).

• Defines “eligible patient” as an individual who meets certain criteria, including, but not limited to, the following (Sec. 1):
• The individual has a terminal illness as determined by their physician and a consulting physician;
• The individual’s physician has determined that there is no satisfactory or comparable Food and Drug Administration approved treatment; and
• The individual has received a recommendation from their physician for the investigational treatment.

• Authorizes a manufacturer to require an individual to pay for investigational treatment and to participate in data collection relating to the treatment (Sec. 1).

• Specifies that a health care insurer or any state agency does not have to provide coverage for the cost of the investigational treatment (Sec. 1).

• Prohibits any state regulatory board from revoking or failing to renew a physician’s license based on the physician’s recommendation of an investigational treatment (Sec. 1).

• Specifies that any official, employee, or agent of the state who blocks an eligible patient’s access to an investigational treatment is guilty of a class 1 misdemeanor (Sec. 1).

Full Bill Text