By: Perry, Hall S.B. No. 265
A BILL TO BE ENTITLED
AN ACT
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.