The text as introduced · 837 words
89R7803 LRM-D
By: Hughes
S.B. No. 670
A BILL TO BE ENTITLED
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.
Monitoring 