CCS#2/SS/HCS/HB 1685 - This act allows, but does not require, a manufacturer of an investigational drug, biological product, or device to make available such investigational drug, product or device to eligible patients with a terminal illness who have considered all other treatment options currently approved by the United States Food and Drug Administration. The act specifies who shall be considered an eligible patient and what constitutes an investigational drug, product or device. The manufacturer may make such drug, product or device available to an eligible patient without receiving compensation or require an eligible patient to pay the costs of or the costs associated with the manufacture of such investigational drug, product, or device. The act also does not require a health care insurer to provide coverage for the cost of any investigational drug, product or device.
This act does not require the Department of Corrections to provide coverage for the cost of any investigational drug, product or device.
No state agency or regulatory board shall revoke, fail to renew, or take any other action against a physician's license based solely on the physician's recommendation to an eligible patient regarding prescription for or treatment with an investigational drug, product, or device.
Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device to an eligible patient with a terminal illness in accordance with this act shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:
(1) The design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or
(2) The safety or effectiveness of the drug or device.
This act is substantially similar to SB 811 (2014).
ADRIANE CROUSE