BILL ANALYSIS

S.B. 269

By: Perry

Public Health

Committee Report (Unamended)

BACKGROUND AND PURPOSE

The bill sponsor has informed the committee that, in recent years, the use of emergency-use authorized vaccines and drugs has increased and that some patients experienced severe complications after receiving emergency-use authorized vaccines or drugs, but these incidents were not always reported to federal monitoring systems like the Vaccine Adverse Event Reporting System or MedWatch due to inconsistent practices among health care providers. S.B. 269 seeks to identify possible side effects or reactions which would help better inform the patient while helping health care workers and policymakers work toward solutions in preventing or treating disease by requiring a physician to report, under certain circumstances, to the federal Vaccine Adverse Event Reporting System or to the FDA through the MedWatch reporting program any serious adverse event the physician's patient suffers relating to a vaccine or drug the patient received that is experimental or investigational or approved or authorized for emergency use by the FDA.

CRIMINAL JUSTICE IMPACT

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

RULEMAKING AUTHORITY

It is the committee's opinion that rulemaking authority is expressly granted to the executive commissioner of the Health and Human Services Commission in SECTION 1 and 2 of this bill.

ANALYSIS

S.B. 269 amends the Health and Safety Code to require a physician to report to the federal Vaccine Adverse Event Reporting System or to the FDA through the MedWatch reporting program, as applicable, any serious adverse event the physician's patient suffers under the following circumstances:

· the physician diagnoses the patient with a condition related to the serious adverse event and knows the patient received a vaccination to which this requirement applies or was administered or used a drug to which this requirement applies; and

· the patient suffers the serious adverse event before the first anniversary of the date the patient was vaccinated or was administered or used the drug.

This requirement applies only to a vaccine or drug that is experimental or investigational or that is approved or authorized for emergency use by the FDA and does not apply to a vaccine or drug administered as part of a clinical trial.

S.B. 269 defines "serious adverse event" as an event that meets the following conditions:

· results in death or is considered life-threatening;

· results in inpatient hospitalization or an extension of the duration of an existing hospitalization;

· results in a persistent or significant incapacity or substantial disruption of an individual's ability to perform normal life functions;

· results in a congenital anomaly or birth defect; or

· results in a medically important condition that, based on the physician's reasonable medical judgment, may require medical or surgical intervention to prevent any such outcome.

S.B. 269 subjects a physician who violates a reporting requirement under the bill's provisions to non-disciplinary corrective action by the Texas Medical Board (TMB) for an initial violation and disciplinary action by the TMB as if the physician violated state law regulating physicians for each subsequent violation.

S.B. 269 prohibits the TMB, for purposes of non-disciplinary corrective action or disciplinary action imposed under the bill's provisions, from considering a violation of a reporting requirement after the third anniversary of the date of the violation. The bill requires the TMB to retain information on each violation in the physician's permanent record.

S.B. 269 requires the executive commissioner of the Health and Human Services Commission, as soon as practicable after the bill's effective date, to adopt rules necessary to implement the bill's provisions.

EFFECTIVE DATE

September 1, 2025.