Texas 2023 - 88th Regular

Texas Senate Bill SB265 Compare Versions

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1	1	By: Perry, Hall S.B. No. 265
2	2
3	3
4	4	A BILL TO BE ENTITLED
5	5	AN ACT
6	6	relating to required reports of certain vaccine-related or
7	7	drug-related adverse events.
8	8	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
9	9	SECTION 1. Subchapter A, Chapter 161, Health and Safety
10	10	Code, is amended by adding Section 161.0103 to read as follows:
11	11	Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED
12	12	ADVERSE EVENTS. (a) In this section, "serious adverse event" means
13	13	an event that:
14	14	(1) results in death;
15	15	(2) is considered life-threatening;
16	16	(3) results in inpatient hospitalization or an
17	17	extension of the duration of an existing hospitalization;
18	18	(4) results in a persistent or significant incapacity
19	19	or substantial disruption of a person's ability to perform normal
20	20	life functions;
21	21	(5) results in a congenital anomaly or birth defect;
22	22	or
23	23	(6) results in a medically important condition that,
24	24	based on the physician's reasonable medical judgment, may require
25	25	medical or surgical intervention to prevent an outcome described by
26	26	Subdivisions (1) through (5).
27	27	(b) This section applies only to a vaccine that is:
28	28	(1) experimental or investigational; or
29	29	(2) approved or authorized for emergency use by the
30	30	United States Food and Drug Administration.
31	31	(c) Notwithstanding Subsection (b), this section does not
32	32	apply to a vaccine administered as part of a clinical trial.
33	33	(d) Notwithstanding any other law, a physician shall report
34	34	to the federal Vaccine Adverse Event Reporting System any serious
35	35	adverse event the physician's patient suffers if:
36	36	(1) the physician:
37	37	(A) diagnoses the patient with a condition
38	38	related to the serious adverse event; and
39	39	(B) knows the patient received a vaccination to
40	40	which this section applies; and
41	41	(2) the patient suffers the serious adverse event
42	42	before the first anniversary of the date the patient was
43	43	vaccinated.
44	44	(e) A physician who violates this section is subject to:
45	45	(1) for an initial violation, non-disciplinary
46	46	corrective action by the Texas Medical Board; and
47	47	(2) for each subsequent violation, disciplinary
48	48	action by the Texas Medical Board as if the physician violated
49	49	Subtitle B, Title 3, Occupations Code.
50	50	(f) For purposes of non-disciplinary corrective action or
51	51	disciplinary action imposed under Subsection (e), a violation of
52	52	this section may not be considered after the third anniversary of
53	53	the date of the violation. However, the Texas Medical Board must
54	54	retain information on each violation in the physician's permanent
55	55	record.
56	56	(g) The executive commissioner shall adopt rules necessary
57	57	to implement this section.
58	58	SECTION 2. Subchapter E, Chapter 431, Health and Safety
59	59	Code, is amended by adding Section 431.1145 to read as follows:
60	60	Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED
61	61	ADVERSE EVENTS. (a) In this section, "serious adverse event" means
62	62	an event that:
63	63	(1) results in death;
64	64	(2) is considered life-threatening;
65	65	(3) results in inpatient hospitalization or an
66	66	extension of the duration of an existing hospitalization;
67	67	(4) results in a persistent or significant incapacity
68	68	or substantial disruption of the person's ability to perform normal
69	69	life functions;
70	70	(5) results in a congenital anomaly or birth defect;
71	71	or
72	72	(6) results in a medically important medical condition
73	73	that, based on the physician's reasonable medical judgment, may
74	74	require medical or surgical intervention to prevent an outcome
75	75	described by Subdivisions (1) through (5).
76	76	(b) This section applies only to a drug that is:
77	77	(1) experimental or investigational; or
78	78	(2) approved or authorized for emergency use by the
79	79	United States Food and Drug Administration.
80	80	(c) Notwithstanding Subsection (b), this section does not
81	81	apply to a drug that is administered or used as part of a clinical
82	82	trial.
83	83	(d) Notwithstanding any other law, a physician shall report
84	84	to the United States Food and Drug Administration through the
85	85	MedWatch Reporting System any serious adverse event the physician's
86	86	patient suffers if:
87	87	(1) the physician:
88	88	(A) diagnoses the patient with a condition
89	89	related to the serious adverse event; and
90	90	(B) knows the patient was administered or used a
91	91	drug to which this section applies; and
92	92	(2) the patient suffers the serious adverse event
93	93	before the first anniversary of the date the patient was
94	94	administered or used the drug.
95	95	(e) A physician who violates this section is subject to:
96	96	(1) for an initial violation, non-disciplinary
97	97	corrective action by the Texas Medical Board; and
98	98	(2) for each subsequent violation, disciplinary
99	99	action by the Texas Medical Board as if the physician violated
100	100	Subtitle B, Title 3, Occupations Code.
101	101	(f) For purposes of non-disciplinary corrective action or
102	102	disciplinary action imposed under Subsection (e), a violation is
103	103	not considered after the third anniversary of the date of the
104	104	violation. However, the Texas Medical Board must retain
105	105	information on each violation in the physician's permanent record.
106	106	(g) The executive commissioner shall adopt rules necessary
107	107	to implement this section.
108	108	SECTION 3. As soon as practicable after the effective date
109	109	of this Act, the executive commissioner of the Health and Human
110	110	Services Commission shall adopt rules necessary to implement the
111	111	changes in law made by this Act.
112	112	SECTION 4. This Act takes effect September 1, 2023.