Texas 2025 - 89th Regular

Texas Senate Bill SB670 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		By: Hughes S.B. No. 670
2		-
3		-
	2	+	(In the Senate - Filed December 19, 2024; February 3, 2025,
	3	+	read first time and referred to Committee on Health & Human
	4	+	Services; March 17, 2025, reported favorably by the following
	5	+	vote: Yeas 8, Nays 0; March 17, 2025, sent to printer.)
	6	+	Click here to see the committee vote
4	7
5	8
6	9		A BILL TO BE ENTITLED
7	10		AN ACT
8	11		relating to patient authorization to access certain
9	12		investigational sun protection products.
10	13		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	14		SECTION 1. (a) The legislature finds that:
12	15		(1) the process for the approval of investigational
13	16		sun protection products in the United States takes many years;
14	17		(2) some patients do not have the luxury of waiting
15	18		until an investigational sun protection product receives final
16	19		approval from the United States Food and Drug Administration;
17	20		(3) the standards of the United States Food and Drug
18	21		Administration for the use of investigational sun protection
19	22		products may deny patients the benefits of potentially life-saving
20	23		products;
21	24		(4) patients have a fundamental right to attempt to
22	25		preserve their health and lives by accessing available
23	26		investigational sun protection products;
24	27		(5) the use of available investigational sun
25	28		protection products is a decision the patient in consultation with
26	29		the patient's physician should make to preserve the patient's
27	30		health or life and is not a decision the government should make; and
28	31		(6) the decision to use an investigational sun
29	32		protection product should be made with full awareness of the
30	33		potential risks, benefits, and consequences to the patient.
31	34		(b) It is the intent of the legislature to allow patients
32	35		the option of using investigational sun protection products.
33	36		SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
34	37		amended by adding Chapter 491 to read as follows:
35	38		CHAPTER 491. PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION
36	39		PRODUCTS
37	40		SUBCHAPTER A. GENERAL PROVISIONS
38	41		Sec. 491.001. DEFINITION. In this chapter,
39	42		"investigational sun protection product" means a sun protection
40	43		product containing an ingredient that has successfully completed
41	44		phase one of a clinical trial but has not yet been approved for
42	45		general use by the United States Food and Drug Administration and
43	46		remains under investigation in the clinical trial.
44	47		SUBCHAPTER B. ELIGIBLE PATIENT ACCESS TO INVESTIGATIONAL SUN
45	48		PROTECTION PRODUCTS
46	49		Sec. 491.051. PATIENT ELIGIBILITY. A patient is eligible
47	50		to access and use an investigational sun protection product if the
48	51		patient's physician:
49	52		(1) in consultation with the patient, has considered
50	53		all other sun protection products currently approved by the United
51	54		States Food and Drug Administration and determined those products
52	55		are less effective in comparison to an investigational sun
53	56		protection product; and
54	57		(2) recommends or prescribes in writing an
55	58		investigational sun protection product for the patient.
56	59		Sec. 491.052. INFORMED CONSENT. (a) Before recommending
57	60		or prescribing an investigational sun protection product, a
58	61		physician must require an eligible patient to sign a written
59	62		informed consent form.
60	63		(b) If the patient is a minor or lacks the mental capacity to
61	64		provide informed consent, a parent or legal guardian may provide
62	65		informed consent on the patient's behalf.
63	66		(c) The Texas Medical Board by rule may adopt a form for the
64	67		informed consent required under this section.
65	68		Sec. 491.053. PROVISION OF INVESTIGATIONAL SUN PROTECTION
66	69		PRODUCT. (a) A manufacturer of an investigational sun protection
67	70		product may make available in accordance with this chapter and any
68	71		rules adopted under this chapter the manufacturer's product to
69	72		eligible patients who provide to the manufacturer the informed
70	73		consent required under Section 491.052.
71	74		(b) This chapter does not require a manufacturer to make
72	75		available an investigational sun protection product to an eligible
73	76		patient.
74	77		(c) A manufacturer may:
75	78		(1) provide an investigational sun protection product
76	79		to an eligible patient without receiving compensation; or
77	80		(2) require an eligible patient to pay the
78	81		manufacturer's costs of, or costs associated with, the manufacture
79	82		of the product.
80	83		Sec. 491.054. NO CAUSE OF ACTION CREATED. This chapter does
81	84		not create a private or state cause of action against a manufacturer
82	85		of an investigational sun protection product or against any other
83	86		person or entity involved in the care of an eligible patient using
84	87		the product for any harm to the eligible patient resulting from the
85	88		product.
86	89		Sec. 491.055. STATE MAY NOT INTERFERE WITH ACCESS TO
87	90		INVESTIGATIONAL SUN PROTECTION PRODUCTS. An official, employee, or
88	91		agent of this state may not block or attempt to block an eligible
89	92		patient's access to an investigational sun protection product under
90	93		this chapter.
91	94		SUBCHAPTER C. HEALTH INSURANCE
92	95		Sec. 491.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
93	96		TRIAL ENROLLEES. This chapter does not affect the coverage of
94	97		enrollees in clinical trials under Chapter 1379, Insurance Code.
95	98		SUBCHAPTER D. PHYSICIANS
96	99		Sec. 491.151. PROHIBITED ACTION AGAINST PHYSICIAN'S
97	100		LICENSE. Notwithstanding any other law, the Texas Medical Board
98	101		may not revoke, fail to renew, suspend, or take any action against a
99	102		physician's license under Subchapter B, Chapter 164, Occupations
100	103		Code, based solely on the physician's recommendation to or
101	104		prescription for an eligible patient regarding access to an
102	105		investigational sun protection product, provided the
103	106		recommendation or prescription for the patient meets the medical
104	107		standard of care and the requirements of this chapter.
105	108		SECTION 3. This Act takes effect immediately if it receives
106	109		a vote of two-thirds of all the members elected to each house, as
107	110		provided by Section 39, Article III, Texas Constitution. If this
108	111		Act does not receive the vote necessary for immediate effect, this
109	112		Act takes effect September 1, 2025.
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