SB 269

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