Senate Bill No. 269 introduces new requirements for reporting serious adverse events related to vaccines and drugs in Texas. The bill adds Section 161.0103 to the Health and Safety Code, which defines a "serious adverse event" and mandates that physicians report such events to the federal Vaccine Adverse Event Reporting System if they diagnose a patient with a condition related to the event and know the patient received a qualifying vaccine. The bill specifies that this requirement applies only to experimental or emergency-use vaccines and excludes those administered as part of clinical trials. Additionally, it outlines penalties for physicians who fail to comply, including non-disciplinary corrective actions for initial violations and disciplinary actions for subsequent violations.
Furthermore, the bill adds Section 431.1145 to the Health and Safety Code, establishing similar reporting requirements for serious adverse events related to drugs. Physicians are required to report these events to the FDA's MedWatch program under the same conditions as outlined for vaccines. The bill also includes provisions for the Texas Medical Board to manage violations and retain records of such violations for a specified period. The executive commissioner is tasked with adopting necessary rules to implement these changes, and the act is set to take effect on September 1, 2025.
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