SB 84

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 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 FDA.

A patient is eligible under the bill if, among other things, the patient has considered

all other available treatment options, 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.