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.