The bill, S.B. No. 670, aims to enhance patient access to investigational sun protection products that have completed phase one of clinical trials but are not yet approved by the FDA. It establishes a new chapter in the Health and Safety Code, Chapter 491, which outlines definitions, eligibility criteria, informed consent requirements, and provisions for the distribution of these products. Patients can access these investigational products if their physician determines that currently approved sun protection products are less effective and provides a written recommendation. Additionally, informed consent must be obtained from the patient or their legal guardian if the patient is a minor or lacks mental capacity.
The bill also includes provisions to protect physicians from disciplinary actions by the Texas Medical Board for recommending or prescribing these investigational products, as long as they adhere to the medical standard of care. It explicitly states that the state cannot interfere with a patient's access to these products and clarifies that no private or state cause of action is created against manufacturers or individuals involved in the care of patients using these products. The bill is set to take effect immediately upon receiving a two-thirds vote from both houses or on September 1, 2025, if that threshold is not met.
Statutes affected: Introduced: ()