S.B. No. 670 is a legislative act aimed at facilitating patient access to investigational sun protection products that have completed phase one of clinical trials but are not yet approved for general use by the FDA. The bill recognizes the lengthy approval process for such products and asserts that patients have the right to access potentially life-saving treatments in consultation with their physicians. It establishes a new chapter in the Health and Safety Code, Chapter 491, which outlines definitions, eligibility criteria, informed consent requirements, and provisions for manufacturers regarding the distribution of these investigational products.
Key provisions include that a patient can only access these products if their physician determines that currently approved sun protection products are less effective and provides a written recommendation. Additionally, physicians must obtain informed consent from patients before prescribing these products, and the Texas Medical Board is authorized to create a standardized consent form. The bill also protects physicians from disciplinary actions related to their recommendations for these investigational products, provided they adhere to the medical standard of care. Importantly, the act prohibits state officials from interfering with patient access to these products and clarifies that it does not create any cause of action against manufacturers for harm resulting from the use of these products.
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