Relating to required reports of certain vaccine-related or drug-related adverse events, the official text

S.B. No. 269

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 an individual'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) authorized or approved 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), the Texas Medical

Board may not consider a violation of this section after the third

anniversary of the date of the violation. The Texas Medical Board

shall retain information on each violation of this section 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 an individual'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) authorized or approved 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 program 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), the Texas Medical

Board may not consider a violation of this section after the third

anniversary of the date of the violation. The Texas Medical Board

shall retain information on each violation of this section 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, 2025.

______________________________
______________________________

President of the Senate
Speaker of the House

I hereby certify that S.B. No. 269 passed the Senate on

April 24, 2025, by the following vote: Yeas 31, Nays 0; and that

the Senate concurred in House amendment on May 26, 2025, by the

following vote: Yeas 31, Nays 0.

______________________________

Secretary of the Senate

I hereby certify that S.B. No. 269 passed the House, with

amendment, on May 22, 2025, by the following vote: Yeas 104,

Nays 37, three present not voting.

______________________________

Chief Clerk of the House

Approved:

______________________________

Date

______________________________

Governor