Right to try off-label therapies. (FE)

What it would have done

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

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.

Who's behind it

2 representatives are its authors⁠. All 2 are Republicans.

1 more lawmaker signed on in support⁠.

What it would cost

State agencies filed a cost estimate. Each opens as a PDF from the Legislature.

• Fiscal Estimate From DSPS