Bill > HB1281

This bill, known as the "Right to Try Act," establishes provisions for terminally ill patients in Colorado to access investigational drugs, biological products, and devices that have successfully completed Phase One of clinical trials but are not yet fully approved by the U.S. Food and Drug Administration (FDA). An "eligible patient" is defined as someone with a terminal illness, who has explored all FDA-approved treatments, has been unable to participate in a clinical trial within 100 miles of their home or was not accepted into one, has received a physician's recommendation for an investigational treatment, and has provided written informed consent, or has a guardian provide consent if they are a minor or lack capacity. The bill clarifies that "investigational drug, biological product, or device" refers to treatments that have passed initial safety testing but are still under FDA-approved investigation, and "terminal illness" means a disease that will soon result in death without life-sustaining procedures or a state of permanent unconsciousness. The act also outlines the requirements for "written, informed consent," which includes detailing approved treatments, acknowledging their likely ineffectiveness, identifying the specific investigational treatment, describing potential outcomes and risks, clarifying that insurance and providers are not obligated to pay, and stating the patient's liability for associated costs unless otherwise contracted. Drug manufacturers are permitted, but not required, to make these treatments available, and they can provide them for free or charge for manufacturing costs. The bill explicitly states that it does not expand existing health insurance coverage requirements for clinical trials, and while insurers may choose to cover investigational treatments, they are not mandated to do so. Furthermore, healthcare providers' licenses and Medicare certifications are protected from disciplinary action solely based on recommending investigational treatments, as long as these recommendations align with medical standards of care, and state officials are prohibited from blocking eligible patients' access to these treatments. Finally, the bill clarifies that it does not create a private right of action for harm resulting from the use of investigational treatments, provided the manufacturer or other involved parties are acting in good faith and exercising reasonable care.