Bill Text: TX SB670 | 2025-2026 | 89th Legislature | Enrolled
Bill Title: Relating to patient authorization to access certain investigational sun protection products.
Sponsorship: Bipartisan Bill
Status: (Passed) 2025-06-20 - Effective immediately [SB670 Detail]
Download: Texas-2025-SB670-Enrolled.html
| S.B. No. 670 | ||
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| 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 | ||
