Relating to patient authorization to access certain investigational sun protection products.
Summary
SB 670 creates a new chapter in the Texas Health and Safety Code to allow certain patients to access and use “investigational sun protection products” before those products receive full FDA approval. The bill defines such products as sun protection products containing an ingredient that has completed phase one of a clinical trial but is still under investigation and not approved for general use. It is framed as a patient-access measure, with legislative findings emphasizing that some patients should not have to wait years for FDA approval when they and their physicians believe an investigational product may better protect their health or life.
Under the bill, a patient may access an investigational sun protection product only if a physician, after consulting with the patient, determines that currently approved sun protection products are less effective and recommends or prescribes the investigational product in writing. The patient must sign an informed consent form, and a parent or legal guardian may consent for a minor or incapacitated patient. The bill also allows manufacturers to provide the product voluntarily, either free or at cost, but does not require them to do so.
Impact
SB 670 amends the Health and Safety Code by adding Chapter 491, which establishes a legal framework for patient access to investigational sun protection products. It limits state interference with access, bars the Texas Medical Board from disciplining a physician solely for recommending or prescribing such a product when the recommendation meets the standard of care and chapter requirements, and states that the chapter does not create a private or state cause of action against manufacturers or others involved in the patient’s care. The bill also clarifies that it does not alter existing insurance coverage rules for clinical trial enrollees under the Insurance Code.
Sentiment
The overall sentiment reflected in the bill text and voting history appears generally supportive of expanding patient access and physician discretion. The bill passed the Senate overwhelmingly, 29-1, and the House by a substantial margin, 115-27 with two present not voting, indicating broad bipartisan acceptance even if not unanimous. The legislative findings and structure suggest the bill was presented as a patient-centered measure intended to reduce regulatory barriers for individuals facing serious health risks.
Contention
The main points of contention are likely the balance between patient access and regulatory oversight, and the extent to which the state should allow access to products that have not completed FDA approval. Opponents may have concerns about safety, informed consent, and whether the bill could weaken the FDA approval process or expose patients to unproven products. The bill addresses some of those concerns by requiring physician involvement, written informed consent, and preserving manufacturer discretion not to provide the product, while also shielding physicians from discipline when acting within the standard of care.
To Create The Right To Try Individualized Investigational Treatment Act; And To Ensure That Patients Have Access To Individualized Investigational Treatment.
A BILL to amend and reenact §§ 54.1-3442.1, 54.1-3442.2, and 54.1-3442.3 of the Code of Virginia, relating to access to investigational drugs, biological products, and devices; patient with severely debilitating condition.
Relating to advisory bodies for the Department of Family and Protective Services, including the creation of the child protective investigations advisory committee and the abolition of the Family and Protective Services Council.
Health: other; individualized investigational treatment for certain patients suffering from a life-threatening or severely debilitating illness; provide for. Amends title & secs. 1, 2, 3, 4, 5, 6 & 7 of 2014 PA 345 (MCL 333.26451 et seq.) & adds sec. 2a.