BILL ANALYSIS
| Senate Research Center | S.B. 670 |
| 89R7803 LRM-D | By: Hughes |
| | Health & Human Services |
| | 3/3/2025 |
| | As Filed |
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
S.B. 670 aims to allow patients to access investigational sun protection products that have not yet received full approval from the United States Food and Drug Administration, similar to the Texas Right to Try Act, House Bill 21, 84(R). The bill outlines the conditions under which patients can access and use these products, emphasizing patient autonomy and informed consent. A physician who has determined that standard FDA-approved products are less effective may recommend or prescribe such a product to a patient. Before a physician can recommend or prescribe an investigational sun protection product, patients must sign a written informed consent form outlining the potential risks, benefits, and consequences.
Manufacturers are not required to provide investigational sun protection products but may choose to do so without compensation or charge for the costs of manufacturing the product.
The bill states that no cause of action is created against manufacturers or other entities involved in caring for patients using these products. Additionally, the Texas Medical Board cannot take action against a physician's license solely based on their recommendation or prescription of these products.
As proposed, S.B. 670 amends current law relating to patient authorization to access certain investigational sun protection products.
RULEMAKING AUTHORITY
Rulemaking authority is expressly granted to the Texas Medical Board in SECTION 2 (Section 491.052, Health and Safety Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. (a) Provides that 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) Provides that it is the intent of the legislature to allow patients the option of using investigational sun protection products.
SECTION 2. Amends Subtitle C, Title 6, Health and Safety Code, by adding Chapter 491, as follows:
CHAPTER 491. PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 491.001. DEFINITION. Defines "investigational sun protection product."
SUBCHAPTER B. ELIGIBLE PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS
Sec. 491.051. PATIENT ELIGIBILITY. Provides that a patient is eligible to access and use an investigational sun protection product if the patient's physician, 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 recommends or prescribes in writing an investigational sun protection product for the patient.
Sec. 491.052. INFORMED CONSENT. (a) Requires a physician, before recommending or prescribing an investigational sun protection product, to require an eligible patient to sign a written informed consent form.
(b) Authorizes a parent or legal guardian, if the patient is a minor or lacks the mental capacity to provide informed consent, to provide informed consent on the patient's behalf.
(c) Authorizes the Texas Medical Board (TMB) by rule to adopt a form for the informed consent required under this section.
Sec. 491.053. PROVISION OF INVESTIGATIONAL SUN PROTECTION PRODUCT. (a) Authorizes a manufacturer of an investigational sun protection product to 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) Provides that this chapter does not require a manufacturer to make available an investigational sun protection product to an eligible patient.
(c) Authorizes a manufacturer to provide an investigational sun protection product to an eligible patient without receiving compensation or 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. Provides that 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. Prohibits an official, employee, or agent of this state from blocking or attempting 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. Provides that this chapter does not affect the coverage of enrollees in clinical trials under Chapter 1379 (Coverage for Routine Patient Care Costs for Enrollees Participating in Certain Clinical Trials), Insurance Code.
SUBCHAPTER D. PHYSICIANS
Sec. 491.151. PROHIBITED ACTION AGAINST PHYSICIAN'S LICENSE. Prohibits TMB, notwithstanding any other law, from revoking, failing to renew, suspending, or taking any action against a physician's license under Subchapter B (License Denial and Disciplinary Actions), Chapter 164 (Disciplinary Actions and Procedures), 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. Effective date: upon passage or September 1, 2025.
