SB269 - Relating to required reports of certain vaccine-related or drug-related adverse events.

      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