BILL ANALYSIS
| Senate Research Center | S.B. 269 |
| 89R1137 MCF-D | By: Perry |
| | Health & Human Services |
| | 4/4/2025 |
| | As Filed |
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
In recent years, the use of emergency-use-authorized vaccines and drugs has become more common. During this time, concerns emerged about underreporting of adverse events related to these treatments, which created gaps in the data needed to assess long-term safety and efficacy. Some patients experienced severe complications shortly after receiving emergency-use-authorized vaccines, but these incidents were not always reported to federal monitoring systems like the Vaccine Adverse Event Reporting System (VAERS) or MedWatch due to inconsistent practices among healthcare providers.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients.
MedWatch is a medical product safety reporting program operating by the United States Food and Drug Administration (FDA). This program is similar to VAERS but applies to drugs, biologics, medical devices, combination products, special nutritional products, cosmetics, and food. The program also relies on voluntary reporting.
By requiring the reporting of adverse vaccine or drug reactions, it would help identify possible side effects or reactions which would help better inform the patient while helping health care workers and policy makers work toward solutions in preventing or treating disease.
As proposed, S.B. 269 amends current law relating to required reports of certain vaccine-related or drug-related adverse events.
RULEMAKING AUTHORITY
Rulemaking authority is expressly granted to the executive commissioner of the Health and Human Services Commission in SECTION 1 (Section 161.0103, Health and Safety Code) and SECTION 2 (Section 431.1145, Health and Safety Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Subchapter A, Chapter 161, Health and Safety Code, by adding Section 161.0103, as follows:
Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED ADVERSE EVENTS. (a) Defines "serious adverse event."
(b) Provides that this section applies only to a vaccine that is experimental or investigational or approved or authorized for emergency use by the United States Food and Drug Administration (FDA).
(c) Provides that, notwithstanding Subsection (b), this section does not apply to a vaccine administered as part of a clinical trial.
(d) Requires a physician, notwithstanding any other law, to report to the federal Vaccine Adverse Event Reporting System any serious adverse event the physician's patient suffers if the physician diagnoses the patient with a condition related to the serious adverse event and knows the patient received a vaccination to which this section applies, and the patient suffers the serious adverse event before the first anniversary of the date the patient was vaccinated.
(e) Provides that a physician who violates this section is subject to, for an initial violation, non-disciplinary corrective action by the Texas Medical Board (TMB) and, for each subsequent violation, disciplinary action by TMB as if the physician violated Subtitle B (Physicians), Title 3 (Health Professions), Occupations Code.
(f) Prohibits TMB, for purposes of non-disciplinary corrective action or disciplinary action imposed under Subsection (e), from considering a violation of this section after the third anniversary of the date of the violation. Requires TMB to retain information on each violation of this section in the physician's permanent record.
(g) Requires the executive commissioner of the Health and Human Services Commission (executive commissioner) to adopt rules necessary to implement this section.
SECTION 2. Amends Subchapter E, Chapter 431, Health and Safety Code, by adding Section 431.1145, as follows:
Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED ADVERSE EVENTS. (a) Defines "serious adverse event."
(b) Provides that this section applies only to a drug that is experimental or investigational or approved or authorized for emergency use by the FDA.
(c) Provides that, notwithstanding Subsection (b), this section does not apply to a drug administered as part of a clinical trial.
(d) Requires a physician, notwithstanding any other law, to report to the FDA through the MedWatch reporting program any serious adverse event the physician's patient suffers if the physician diagnoses the patient with a condition related to the serious adverse event and knows the patient was administered or used a drug to which this section applies and the patient suffers the serious adverse event before the first anniversary of the date the patient was administered or used the drug.
(e) Provides that a physician who violates this section is subject to, for an initial violation, non-disciplinary corrective action by TMB and for each subsequent violation, disciplinary action by TMB as if the physician violated Subtitle B, Title 3, Occupations Code.
(f) Prohibits TMB, for purposes of non-disciplinary corrective action or disciplinary action imposed under Subsection (e), from considering a violation of this section after the third anniversary of the date of the violation. Requires TMB to retain information on each violation of this section in the physician's permanent record.
(g) Requires the executive commissioner to adopt rules necessary to implement this section.
SECTION 3. Requires the executive commissioner, as soon as practicable after the effective date of this Act, to adopt rules necessary to implement the changes in law made by this Act.
SECTION 4. Effective date: September 1, 2025.
