SB670 - Relating to patient authorization to access certain investigational sun protection products.

      S.B. No. 670         AN ACT   relating to patient authorization to access certain   investigational sun protection products.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  (a) The legislature finds that:                (1)  the process for the approval of investigational   sun protection products in the United States takes many years;                (2)  some patients do not have the luxury of waiting   until an investigational sun protection product receives final   approval from the United States Food and Drug Administration;                (3)  the standards of the United States Food and Drug   Administration for the use of investigational sun protection   products may deny patients the benefits of potentially life-saving   products;                (4)  patients have a fundamental right to attempt to   preserve their health and lives by accessing available   investigational sun protection products;                (5)  the use of available investigational sun   protection products is a decision the patient in consultation with   the patient's physician should make to preserve the patient's   health or life and is not a decision the government should make; and                (6)  the decision to use an investigational sun   protection product should be made with full awareness of the   potential risks, benefits, and consequences to the patient.          (b)  It is the intent of the legislature to allow patients   the option of using investigational sun protection products.          SECTION 2.  Subtitle C, Title 6, Health and Safety Code, is   amended by adding Chapter 491 to read as follows:   CHAPTER 491.   PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION   PRODUCTS   SUBCHAPTER A.   GENERAL PROVISIONS           Sec.   491.001.     DEFINITION. In this chapter,   "investigational sun protection product" means a sun protection   product containing an ingredient that has successfully completed   phase one of a clinical trial but has not yet been approved for   general use by the United States Food and Drug Administration and   remains under investigation in the clinical trial.   SUBCHAPTER B.   ELIGIBLE PATIENT ACCESS TO INVESTIGATIONAL SUN   PROTECTION PRODUCTS           Sec.   491.051.     PATIENT ELIGIBILITY. A patient is eligible   to access and use an investigational sun protection product if the   patient's physician:                 (1)     in consultation with the patient, has considered   all other sun protection products currently approved by the United   States Food and Drug Administration and determined those products   are less effective in comparison to an investigational sun   protection product; and                 (2)     recommends or prescribes in writing an   investigational sun protection product for the patient.           Sec.   491.052.     INFORMED CONSENT. (a) Before recommending   or prescribing an investigational sun protection product, a   physician must require an eligible patient to sign a written   informed consent form.           (b)     If the patient is a minor or lacks the mental capacity to   provide informed consent, a parent or legal guardian may provide   informed consent on the patient's behalf.           (c)     The Texas Medical Board by rule may adopt a form for the   informed consent required under this section.           Sec.   491.053.     PROVISION OF INVESTIGATIONAL SUN PROTECTION   PRODUCT. (a) A manufacturer of an investigational sun protection   product may make available in accordance with this chapter and any   rules adopted under this chapter the manufacturer's product to   eligible patients who provide to the manufacturer the informed   consent required under Section 491.052.           (b)     This chapter does not require a manufacturer to make   available an investigational sun protection product to an eligible   patient.           (c)  A manufacturer may:                 (1)     provide an investigational sun protection product   to an eligible patient without receiving compensation; or                 (2)     require an eligible patient to pay the   manufacturer's costs of, or costs associated with, the manufacture   of the product.           Sec.   491.054.     NO CAUSE OF ACTION CREATED. This chapter does   not create a private or state cause of action against a manufacturer   of an investigational sun protection product or against any other   person or entity involved in the care of an eligible patient using   the product for any harm to the eligible patient resulting from the   product.           Sec.   491.055.     STATE MAY NOT INTERFERE WITH ACCESS TO   INVESTIGATIONAL SUN PROTECTION PRODUCTS. An official, employee, or   agent of this state may not block or attempt to block an eligible   patient's access to an investigational sun protection product under   this chapter.   SUBCHAPTER C.   HEALTH INSURANCE           Sec.   491.101.     EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL   TRIAL ENROLLEES. This chapter does not affect the coverage of   enrollees in clinical trials under Chapter 1379, Insurance Code.   SUBCHAPTER D.   PHYSICIANS           Sec.   491.151.     PROHIBITED ACTION AGAINST PHYSICIAN'S   LICENSE. Notwithstanding any other law, the Texas Medical Board   may not revoke, fail to renew, suspend, or take any action against a   physician's license under Subchapter B, Chapter 164, Occupations   Code, based solely on the physician's recommendation to or   prescription for an eligible patient regarding access to an   investigational sun protection product, provided the   recommendation or prescription for the patient meets the medical   standard of care and the requirements of this chapter.            SECTION 3.  This Act takes effect immediately if it receives   a vote of two-thirds of all the members elected to each house, as   provided by Section 39, Article III, Texas Constitution.  If this   Act does not receive the vote necessary for immediate effect, this   Act takes effect September 1, 2025.               ______________________________ ______________________________      President of the Senate Speaker of the House                 I hereby certify that S.B. No. 670 passed the Senate on   April 10, 2025, by the following vote:  Yeas 29, Nays 1.       ______________________________   Secretary of the Senate                I hereby certify that S.B. No. 670 passed the House on   May 21, 2025, by the following vote:  Yeas 115, Nays 27, two   present not voting.       ______________________________   Chief Clerk of the House            Approved:     ______________________________                Date       ______________________________              Governor