Texas 2023 - 88th Regular

Texas Senate Bill SB773 Compare Versions

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Version 2 (New)

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1	1	S.B. No. 773
2	2
3	3
4	4	AN ACT
5	5	relating to access to certain investigational drugs, biological
6	6	products, and devices used in clinical trials by patients with
7	7	severe chronic diseases.
8	8	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
9	9	SECTION 1. (a) This Act shall be known as the "Medical
10	10	Freedom Act."
11	11	(b) The legislature finds that:
12	12	(1) the Right To Try Act, as added by Chapter 502 (H.B.
13	13	21), Acts of the 84th Legislature, Regular Session, 2015, has had
14	14	tremendous success in saving the lives of many patients with a
15	15	terminal illness;
16	16	(2) the process for approving the use of
17	17	investigational drugs, biological products, and devices by
18	18	patients without a terminal illness who need access to the drugs,
19	19	products, or devices continues to take many years in the United
20	20	States;
21	21	(3) patients who are battling a severe chronic disease
22	22	that is debilitating or causes severe pain do not have the luxury of
23	23	waiting until the United States Food and Drug Administration gives
24	24	final approval for an investigational drug, biological product, or
25	25	device;
26	26	(4) the United States Food and Drug Administration
27	27	standards for the use of investigational drugs, biological
28	28	products, and devices may deny the benefits of potentially
29	29	life-altering treatment to patients with a severe chronic disease;
30	30	(5) patients with a severe chronic disease have a
31	31	fundamental right to attempt to pursue the preservation of their
32	32	state of life by accessing available investigational drugs,
33	33	biological products, and devices;
34	34	(6) the use of available investigational drugs,
35	35	biological products, and devices is a decision that a patient with a
36	36	severe chronic disease should make in consultation with the
37	37	patient's physician and is not a decision the government should
38	38	make; and
39	39	(7) the decision to use an investigational drug,
40	40	biological product, or device should be made with full awareness of
41	41	the potential risks, benefits, and consequences to a patient with a
42	42	severe chronic disease and the patient's family.
43	43	(c) It is the intent of the legislature to allow patients
44	44	with a severe chronic disease to use potentially life-altering
45	45	investigational drugs, biological products, and devices.
46	46	SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
47	47	amended by adding Chapter 490 to read as follows:
48	48	CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
49	49	WITH SEVERE CHRONIC DISEASES
50	50	SUBCHAPTER A. GENERAL PROVISIONS
51	51	Sec. 490.001. DEFINITIONS. In this chapter:
52	52	(1) "Commissioner" means the commissioner of state
53	53	health services.
54	54	(2) "Executive commissioner" means the executive
55	55	commissioner of the Health and Human Services Commission.
56	56	(3) "Investigational drug, biological product, or
57	57	device" means a drug, biological product, or device that has
58	58	successfully completed phase one of a clinical trial but the United
59	59	States Food and Drug Administration or its international equivalent
60	60	has not yet approved for general use and that remains under
61	61	investigation in the clinical trial. The term does not include
62	62	low-THC cannabis, as defined by Section 169.001, Occupations Code,
63	63	or a product containing marihuana, as defined by Section 481.002,
64	64	regardless of whether the cannabis or product successfully
65	65	completed phase one of a clinical trial.
66	66	(4) "Severe chronic disease" means a condition,
67	67	injury, or illness that:
68	68	(A) may be treated;
69	69	(B) may not be cured or eliminated; and
70	70	(C) entails significant functional impairment or
71	71	severe pain.
72	72	Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The
73	73	commissioner shall designate the medical conditions considered to
74	74	be severe chronic diseases under this chapter.
75	75	Sec. 490.003. RULES. The executive commissioner shall
76	76	adopt rules necessary to administer this chapter.
77	77	SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
78	78	PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES
79	79	Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible
80	80	to access and use an investigational drug, biological product, or
81	81	device under this chapter if:
82	82	(1) the patient has a severe chronic disease the
83	83	commissioner designates under Section 490.002 that the patient's
84	84	treating physician confirms in writing;
85	85	(2) the use of the investigational drug, biological
86	86	product, or device is consistent with this chapter and rules
87	87	adopted under this chapter; and
88	88	(3) the patient's physician:
89	89	(A) in consultation with the patient, considers
90	90	all other treatment options the United States Food and Drug
91	91	Administration has currently approved and determines those
92	92	treatment options are unavailable or unlikely to provide relief for
93	93	the significant impairment or severe pain associated with the
94	94	patient's severe chronic disease; and
95	95	(B) recommends or prescribes in writing the
96	96	patient's use of a specific class of investigational drug,
97	97	biological product, or device.
98	98	Sec. 490.052. INFORMED CONSENT. (a) Before receiving an
99	99	investigational drug, biological product, or device, an eligible
100	100	patient must sign a written informed consent. If the patient is a
101	101	minor or lacks the mental capacity to provide informed consent, a
102	102	parent, guardian, or conservator may provide informed consent on
103	103	the patient's behalf.
104	104	(b) The commissioner may prescribe a form for the informed
105	105	consent required under this section.
106	106	Sec. 490.053. PROVISION OF INVESTIGATIONAL DRUG,
107	107	BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
108	108	of an investigational drug, biological product, or device may make
109	109	available the manufacturer's investigational drug, biological
110	110	product, or device to eligible patients in accordance with this
111	111	chapter if the patient provides to the manufacturer the informed
112	112	consent required under Section 490.052.
113	113	(b) This chapter does not require a manufacturer to make
114	114	available an investigational drug, biological product, or device to
115	115	an eligible patient.
116	116	(c) If a manufacturer makes available an investigational
117	117	drug, biological product, or device to an eligible patient under
118	118	this subchapter, the manufacturer must provide the investigational
119	119	drug, biological product, or device to the eligible patient without
120	120	receiving compensation.
121	121	Sec. 490.054. CAUSE OF ACTION NOT CREATED. This chapter
122	122	does not create a private or state cause of action against a
123	123	manufacturer of an investigational drug, biological product, or
124	124	device or against any other person or entity involved in the care of
125	125	an eligible patient using the investigational drug, biological
126	126	product, or device for any harm to the patient resulting from the
127	127	investigational drug, biological product, or device.
128	128	Sec. 490.055. STATE MAY NOT INTERFERE WITH ACCESS TO
129	129	INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
130	130	employee, or agent of this state may not block or attempt to block
131	131	an eligible patient's access to an investigational drug, biological
132	132	product, or device under this chapter unless the drug, biological
133	133	product, or device is considered adulterated or misbranded under
134	134	Chapter 431. For purposes of this section, a governmental entity
135	135	may not consider the drug, biological product, or device to be
136	136	adulterated or misbranded based solely on the United States Food
137	137	and Drug Administration not yet finally approving the drug,
138	138	biological product, or device.
139	139	SUBCHAPTER C. HEALTH INSURANCE
140	140	Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
141	141	TRIAL ENROLLEES. This chapter does not affect the coverage of
142	142	enrollees in clinical trials under Chapter 1379, Insurance Code.
143	143	SUBCHAPTER D. PHYSICIANS
144	144	Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE
145	145	PROHIBITED. Notwithstanding any other law, the Texas Medical Board
146	146	may not revoke, fail to renew, suspend, or take any action against
147	147	a physician's license under Subchapter B, Chapter 164, Occupations
148	148	Code, based solely on the physician's recommendations to an
149	149	eligible patient regarding access to or treatment with an
150	150	investigational drug, biological product, or device, provided that
151	151	the recommendations meet the requirements of this chapter and rules
152	152	adopted under this chapter.
153	153	SECTION 3. (a) As soon as practicable after the effective
154	154	date of this Act, the commissioner of state health services shall
155	155	designate the medical conditions considered to be severe chronic
156	156	diseases as required by Section 490.002, Health and Safety Code, as
157	157	added by this Act.
158	158	(b) As soon as practicable after the effective date of this
159	159	Act, the executive commissioner of the Health and Human Services
160	160	Commission shall adopt the rules required by Section 490.003,
161	161	Health and Safety Code, as added by this Act. The executive
162	162	commissioner may adopt initial rules in the manner provided by law
163	163	for emergency rules.
164	164	SECTION 4. This Act takes effect immediately if it receives
165	165	a vote of two-thirds of all the members elected to each house, as
166	166	provided by Section 39, Article III, Texas Constitution. If this
167	167	Act does not receive the vote necessary for immediate effect, this
168	168	Act takes effect September 1, 2023.
169	169	______________________________ ______________________________
170	170	President of the Senate Speaker of the House
171	171	I hereby certify that S.B. No. 773 passed the Senate on
172	172	April 27, 2023, by the following vote: Yeas 31, Nays 0;
173	173	May 16, 2023, Senate refused to concur in House amendments and
174	174	requested appointment of Conference Committee; May 19, 2023, House
175	175	granted request of the Senate; May 26, 2023, Senate adopted
176	176	Conference Committee Report by the following vote: Yeas 31,
177	177	Nays 0.
178	178	______________________________
179	179	Secretary of the Senate
180	180	I hereby certify that S.B. No. 773 passed the House, with
181	181	amendments, on May 12, 2023, by the following vote: Yeas 135,
182	182	Nays 5, two present not voting; May 19, 2023, House granted request
183	183	of the Senate for appointment of Conference Committee;
184	184	May 25, 2023, House adopted Conference Committee Report by the
185	185	following vote: Yeas 141, Nays 1, two present not voting.
186	186	______________________________
187	187	Chief Clerk of the House
188	188	Approved:
189	189	______________________________
190	190	Date
191	191	______________________________
192	192	Governor