AB 979

Under current law, a manufacturer of an investigational drug, device, or

biological product may make the investigational drug, device, or biological product

available to an eligible patient. “Investigational drug, device, or biological product”

is defined to mean a drug, device, or biological product that has not been approved

or licensed for use by the federal Food and Drug Administration and that meets

certain conditions relating to its status in clinical trials approved by the FDA. A

patient is eligible to receive an investigational drug, device, or biological product if

the patient meets several conditions, including that he or she has been diagnosed

with a life-threatening disease or condition, he or she has exhausted approved

treatment options and is unable to participate in a clinical trial involving the

investigational drug, device, or biological product, and he or she has received a

recommendation or prescription order from his or her treating physician for the

investigational drug, device, or biological product. If a manufacturer decides to make

an investigational drug, device, or biological product available to an eligible patient,

the manufacturer may charge an amount for the investigational drug, device, or

biological product that is not more than the cost to manufacture the investigational

drug, device, or biological product provided to the eligible patient. Current law also

protects certain individuals and entities from liability resulting from the design,

development, clinical testing, investigation, manufacture, labeling, distribution,

sale, purchase, donation, dispensing, prescribing, administration, or use of the

investigational drug, device, or biological product in certain circumstances.

This bill adds off-label therapies to those drugs, devices, or biological products

that an eligible patient may receive. Under the bill, “off-label therapy” is defined to

mean a use of a drug, device, or biological product approved by the FDA other than

a use approved by the FDA. The same requirements and protections that exist under

current law for investigational drugs, devices, and biological products also apply to

off-label therapies.