Essay On Causality Assessment

Explain: Causality or relatedness assessment determines whether there is a “reasonable possibility” that the product is causally related to the adverse event. (1) In practice, FDA (21CFR32) is using the term “suspected adverse drug reaction” (SADR), to emphasize the suspicion that the drug is a possible cause of the adverse event. Suspected Adverse Drug reaction (SADR) implies a lesser degree of certainty about causality than the term Adverse Reaction. (2) The European Union ENTR/ CT3 clarified that all adverse events assessed by the investigator or the sponsor and imply having a reasonable evidence for a causal relationship to an investigational medicinal product qualify as adverse reactions. (2)

In practice, many companies have two types

(1) Because if a healthcare professional or consumer takes the time to report an AE to the manufacturer or to the FDA, this indicates that the reporter believes, to some degree, that the drug may have caused the AE. (2) However, many companies do causality assessments on spontaneous reports, because the (1) current United States regulations require a causality assessment for IND expedited 7- and 15-day reports.

Global Introspection: Having one or more smart, ethical, and experienced drug safety experts to read the case details, and make a causality judgments based on their expertise in the field of medicine. (2) Causality assessment includes an evaluation whether the AE occurred in the expected drug’s pharmacological time frame, if no problems or symptoms were obvious before exposure to the drug, if no other medical conditions or medications could cause this AE, or if it is a dose response. Moreover, the causality assessment includes evaluation of the dechallenge/rechallenge information, biologic plausibility, positive in vitro or in vivo test, and similar findings in toxicity studies.