Bill > SB1454

This bill modifies existing law to expand access to investigational drugs, biological products, and devices for patients with terminal, life-threatening, or severely debilitating conditions. The bill defines "eligible patients" as those who have exhausted standard FDA-approved treatment options, received a physician's recommendation, and provided informed consent. It allows pharmaceutical manufacturers to make investigational treatments available to such patients, though they are not required to do so. The bill protects physicians from license revocation or disciplinary action solely for recommending these investigational treatments and provides liability protection for manufacturers, distributors, and healthcare providers involved in providing these treatments, except in cases of gross negligence. The legislation does not require health insurers or the department of corrections to cover the cost of these investigational treatments. Key additions include defining "life-threatening condition" as a disease with a high likelihood of death and "severely debilitating condition" as a disease causing major irreversible morbidity. The bill also stipulates that if a clinical trial is closed due to lack of efficacy or toxicity, the drug cannot be offered, and patients must be notified of any safety information from the clinical trial.

Health and Social Services

https://www.senate.mo.gov/26info/BTS_Web/Bill.aspx?SessionType=R&BillID=27966