AB 179

Under this bill, a manufacturer of an investigational drug, device, or biological

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

to an eligible patient. Under the bill, an investigational drug, device, or biological

product is one that has not yet been approved for general use by the federal Food and

Drug Administration, but, among other requirements, has successfully completed a

phase one clinical trial and remains under investigation or is pending approval by

the federal food and drug administration for general use. A patient is eligible under

the bill if, among other things, the patient has considered all treatment options

approved for general use, has received a treating physician's recommendation or

prescription order for an investigational drug, device, or biological product, and has

given written informed consent for use of the investigational drug, device, or

biological product.

The bill provides a limitation of liability under state law for a manufacturer,

distributor, pharmacist, physician or other practitioner, or other person who makes

available, delivers, distributes, prescribes, dispenses, or administers an

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

with the bill's provisions, and who in doing so exercises reasonable care.

Finally, the bill prohibits an official, employee, or agent of the state from

blocking or attempting to block an eligible patient's access to an investigational drug,

device, or biological product.