Relating to authorizing patients with certain terminal conditions to access certain investigational drugs, biological products, and devices that are in clinical trials.
If enacted, HB438 would amend the Texas Health and Safety Code to introduce Chapter 489, which establishes legal pathways for patients with terminal conditions to access investigational treatments that have completed phase one of clinical trials. The bill outlines the criteria for patient eligibility, necessitating a physician's attestation and a comprehensive discussion on alternative treatment options. This legislation could significantly alter the existing framework of patient rights regarding access to experimental therapies, offering hope to those with few options left.
House Bill 438, known as the 'Right To Try Act', is designed to provide patients diagnosed with terminal conditions access to investigational drugs, biological products, and devices that are currently in clinical trials. The bill recognizes the urgency faced by terminally ill patients who may not have time to wait for the lengthy FDA approval process for new treatments. It aims to empower these patients by allowing them to make informed choices about using potentially life-saving investigational treatments in consultation with their healthcare providers.
Notable points of contention surrounding HB438 focus on the balance between patient autonomy and the potential risks of accessing unapproved treatments. Critics may raise concerns about the adequacy of informed consent, emphasizing the importance of patients fully understanding the risks, benefits, and possible outcomes of using investigational drugs. The bill includes provisions that such treatments might not be covered by health benefit plans, placing the financial responsibility on patients. Therefore, discussions about equity in healthcare access could arise, especially for economically disadvantaged patients needing these treatments.