Texas 2025 - 89th Regular

Texas Senate Bill SB269 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	By: Perry, Hall S.B. No. 269
2		-	Sparks
	1	+	By: Perry S.B. No. 269
	2	+	(In the Senate - Filed November 12, 2024; February 3, 2025,
	3	+	read first time and referred to Committee on Health & Human
	4	+	Services; April 14, 2025, reported favorably by the following
	5	+	vote: Yeas 9, Nays 0; April 14, 2025, sent to printer.)
	6	+	Click here to see the committee vote
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7	11		A BILL TO BE ENTITLED
8	12		AN ACT
9	13		relating to required reports of certain vaccine-related or
10	14		drug-related adverse events.
11	15		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
12	16		SECTION 1. Subchapter A, Chapter 161, Health and Safety
13	17		Code, is amended by adding Section 161.0103 to read as follows:
14	18		Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED
15	19		ADVERSE EVENTS. (a) In this section, "serious adverse event" means
16	20		an event that:
17	21		(1) results in death;
18	22		(2) is considered life-threatening;
19	23		(3) results in inpatient hospitalization or an
20	24		extension of the duration of an existing hospitalization;
21	25		(4) results in a persistent or significant incapacity
22	26		or substantial disruption of an individual's ability to perform
23	27		normal life functions;
24	28		(5) results in a congenital anomaly or birth defect;
25	29		or
26	30		(6) results in a medically important condition that,
27	31		based on the physician's reasonable medical judgment, may require
28	32		medical or surgical intervention to prevent an outcome described by
29	33		Subdivisions (1) through (5).
30	34		(b) This section applies only to a vaccine that is:
31	35		(1) experimental or investigational; or
32	36		(2) approved or authorized for emergency use by the
33	37		United States Food and Drug Administration.
34	38		(c) Notwithstanding Subsection (b), this section does not
35	39		apply to a vaccine administered as part of a clinical trial.
36	40		(d) Notwithstanding any other law, a physician shall report
37	41		to the federal Vaccine Adverse Event Reporting System any serious
38	42		adverse event the physician's patient suffers if:
39	43		(1) the physician:
40	44		(A) diagnoses the patient with a condition
41	45		related to the serious adverse event; and
42	46		(B) knows the patient received a vaccination to
43	47		which this section applies; and
44	48		(2) the patient suffers the serious adverse event
45	49		before the first anniversary of the date the patient was
46	50		vaccinated.
47	51		(e) A physician who violates this section is subject to:
48	52		(1) for an initial violation, non-disciplinary
49	53		corrective action by the Texas Medical Board; and
50	54		(2) for each subsequent violation, disciplinary
51	55		action by the Texas Medical Board as if the physician violated
52	56		Subtitle B, Title 3, Occupations Code.
53	57		(f) For purposes of non-disciplinary corrective action or
54	58		disciplinary action imposed under Subsection (e), the Texas Medical
55	59		Board may not consider a violation of this section after the third
56	60		anniversary of the date of the violation. The Texas Medical Board
57	61		shall retain information on each violation of this section in the
58	62		physician's permanent record.
59	63		(g) The executive commissioner shall adopt rules necessary
60	64		to implement this section.
61	65		SECTION 2. Subchapter E, Chapter 431, Health and Safety
62	66		Code, is amended by adding Section 431.1145 to read as follows:
63	67		Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED
64	68		ADVERSE EVENTS. (a) In this section, "serious adverse event" means
65	69		an event that:
66	70		(1) results in death;
67	71		(2) is considered life-threatening;
68	72		(3) results in inpatient hospitalization or an
69	73		extension of the duration of an existing hospitalization;
70	74		(4) results in a persistent or significant incapacity
71	75		or substantial disruption of an individual's ability to perform
72	76		normal life functions;
73	77		(5) results in a congenital anomaly or birth defect;
74	78		or
75	79		(6) results in a medically important medical condition
76	80		that, based on the physician's reasonable medical judgment, may
77	81		require medical or surgical intervention to prevent an outcome
78	82		described by Subdivisions (1) through (5).
79	83		(b) This section applies only to a drug that is:
80	84		(1) experimental or investigational; or
81	85		(2) approved or authorized for emergency use by the
82	86		United States Food and Drug Administration.
83	87		(c) Notwithstanding Subsection (b), this section does not
84	88		apply to a drug that is administered or used as part of a clinical
85	89		trial.
86	90		(d) Notwithstanding any other law, a physician shall report
87	91		to the United States Food and Drug Administration through the
88	92		MedWatch reporting program any serious adverse event the
89	93		physician's patient suffers if:
90	94		(1) the physician:
91	95		(A) diagnoses the patient with a condition
92	96		related to the serious adverse event; and
93	97		(B) knows the patient was administered or used a
94	98		drug to which this section applies; and
95	99		(2) the patient suffers the serious adverse event
96	100		before the first anniversary of the date the patient was
97	101		administered or used the drug.
98	102		(e) A physician who violates this section is subject to:
99	103		(1) for an initial violation, non-disciplinary
100	104		corrective action by the Texas Medical Board; and
101	105		(2) for each subsequent violation, disciplinary
102	106		action by the Texas Medical Board as if the physician violated
103	107		Subtitle B, Title 3, Occupations Code.
104	108		(f) For purposes of non-disciplinary corrective action or
105	109		disciplinary action imposed under Subsection (e), the Texas Medical
106	110		Board may not consider a violation of this section after the third
107	111		anniversary of the date of the violation. The Texas Medical Board
108	112		shall retain information on each violation of this section in the
109	113		physician's permanent record.
110	114		(g) The executive commissioner shall adopt rules necessary
111	115		to implement this section.
112	116		SECTION 3. As soon as practicable after the effective date
113	117		of this Act, the executive commissioner of the Health and Human
114	118		Services Commission shall adopt rules necessary to implement the
115	119		changes in law made by this Act.
116	120		SECTION 4. This Act takes effect September 1, 2025.
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