S.B. No. 269 amends the Health and Safety Code of Texas by adding new sections that require physicians to report certain serious adverse events related to vaccines and drugs. Specifically, Section 161.0103 mandates that physicians report any serious adverse events associated with vaccines that are either experimental or authorized for emergency use by the FDA. A "serious adverse event" is defined as one that results in death, is life-threatening, requires hospitalization, causes significant incapacity, results in congenital anomalies, or necessitates medical intervention. The reporting obligation applies if the event occurs within one year of vaccination, and failure to comply can lead to corrective or disciplinary actions by the Texas Medical Board.
Similarly, Section 431.1145 establishes a reporting requirement for serious adverse events related to drugs under the same conditions as vaccines. Physicians must report these events to the FDA's MedWatch program if they diagnose a patient with a condition related to the adverse event and are aware that the patient used a relevant drug. The bill also stipulates that the Texas Medical Board cannot consider violations of these reporting requirements after three years, and it mandates the adoption of necessary rules by the executive commissioner to implement these changes. The act is set to take effect on September 1, 2025.
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