Bill Text: TX SB265 | 2023-2024 | 88th Legislature | Engrossed
Bill Title: Relating to required reports of certain vaccine-related or drug-related adverse events.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Engrossed - Dead) 2023-04-28 - Referred to Public Health [SB265 Detail]
Download: Texas-2023-SB265-Engrossed.html
By: Perry, Hall | S.B. No. 265 |
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relating to required reports of certain vaccine-related or | ||
drug-related adverse events. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subchapter A, Chapter 161, Health and Safety | ||
Code, is amended by adding Section 161.0103 to read as follows: | ||
Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED | ||
ADVERSE EVENTS. (a) In this section, "serious adverse event" means | ||
an event that: | ||
(1) results in death; | ||
(2) is considered life-threatening; | ||
(3) results in inpatient hospitalization or an | ||
extension of the duration of an existing hospitalization; | ||
(4) results in a persistent or significant incapacity | ||
or substantial disruption of a person's ability to perform normal | ||
life functions; | ||
(5) results in a congenital anomaly or birth defect; | ||
or | ||
(6) results in a medically important condition that, | ||
based on the physician's reasonable medical judgment, may require | ||
medical or surgical intervention to prevent an outcome described by | ||
Subdivisions (1) through (5). | ||
(b) This section applies only to a vaccine that is: | ||
(1) experimental or investigational; or | ||
(2) approved or authorized for emergency use by the | ||
United States Food and Drug Administration. | ||
(c) Notwithstanding Subsection (b), this section does not | ||
apply to a vaccine administered as part of a clinical trial. | ||
(d) Notwithstanding any other law, a physician shall report | ||
to the federal Vaccine Adverse Event Reporting System any serious | ||
adverse event the physician's patient suffers if: | ||
(1) the physician: | ||
(A) diagnoses the patient with a condition | ||
related to the serious adverse event; and | ||
(B) knows the patient received a vaccination to | ||
which this section applies; and | ||
(2) the patient suffers the serious adverse event | ||
before the first anniversary of the date the patient was | ||
vaccinated. | ||
(e) A physician who violates this section is subject to: | ||
(1) for an initial violation, non-disciplinary | ||
corrective action by the Texas Medical Board; and | ||
(2) for each subsequent violation, disciplinary | ||
action by the Texas Medical Board as if the physician violated | ||
Subtitle B, Title 3, Occupations Code. | ||
(f) For purposes of non-disciplinary corrective action or | ||
disciplinary action imposed under Subsection (e), a violation of | ||
this section may not be considered after the third anniversary of | ||
the date of the violation. However, the Texas Medical Board must | ||
retain information on each violation in the physician's permanent | ||
record. | ||
(g) The executive commissioner shall adopt rules necessary | ||
to implement this section. | ||
SECTION 2. Subchapter E, Chapter 431, Health and Safety | ||
Code, is amended by adding Section 431.1145 to read as follows: | ||
Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED | ||
ADVERSE EVENTS. (a) In this section, "serious adverse event" means | ||
an event that: | ||
(1) results in death; | ||
(2) is considered life-threatening; | ||
(3) results in inpatient hospitalization or an | ||
extension of the duration of an existing hospitalization; | ||
(4) results in a persistent or significant incapacity | ||
or substantial disruption of the person's ability to perform normal | ||
life functions; | ||
(5) results in a congenital anomaly or birth defect; | ||
or | ||
(6) results in a medically important medical condition | ||
that, based on the physician's reasonable medical judgment, may | ||
require medical or surgical intervention to prevent an outcome | ||
described by Subdivisions (1) through (5). | ||
(b) This section applies only to a drug that is: | ||
(1) experimental or investigational; or | ||
(2) approved or authorized for emergency use by the | ||
United States Food and Drug Administration. | ||
(c) Notwithstanding Subsection (b), this section does not | ||
apply to a drug that is administered or used as part of a clinical | ||
trial. | ||
(d) Notwithstanding any other law, a physician shall report | ||
to the United States Food and Drug Administration through the | ||
MedWatch Reporting System any serious adverse event the physician's | ||
patient suffers if: | ||
(1) the physician: | ||
(A) diagnoses the patient with a condition | ||
related to the serious adverse event; and | ||
(B) knows the patient was administered or used a | ||
drug to which this section applies; and | ||
(2) the patient suffers the serious adverse event | ||
before the first anniversary of the date the patient was | ||
administered or used the drug. | ||
(e) A physician who violates this section is subject to: | ||
(1) for an initial violation, non-disciplinary | ||
corrective action by the Texas Medical Board; and | ||
(2) for each subsequent violation, disciplinary | ||
action by the Texas Medical Board as if the physician violated | ||
Subtitle B, Title 3, Occupations Code. | ||
(f) For purposes of non-disciplinary corrective action or | ||
disciplinary action imposed under Subsection (e), a violation is | ||
not considered after the third anniversary of the date of the | ||
violation. However, the Texas Medical Board must retain | ||
information on each violation in the physician's permanent record. | ||
(g) The executive commissioner shall adopt rules necessary | ||
to implement this section. | ||
SECTION 3. As soon as practicable after the effective date | ||
of this Act, the executive commissioner of the Health and Human | ||
Services Commission shall adopt rules necessary to implement the | ||
changes in law made by this Act. | ||
SECTION 4. This Act takes effect September 1, 2023. |