Access to investigational drugs, devices, and biological products and limitations on liability related to their use

What it would have done

Summary by the Legislative Reference Bureau, the Legislature's nonpartisan drafting office. It's their wording, not ours.

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.

Who's behind it

25 lawmakers are its authors⁠. 13 are Republicans and 12 are Democrats.

6 more lawmakers signed on in support⁠.