USA – FDA Officials Explain When Litigation Can Impact Drug Safety Signals

The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an impact on detecting safety signals, Monica Muñoz and Gerald del Pan of FDA’s Office of Surveillance and Epidemiology wrote recently in a research letter to the journal Drug Safety.

The letter came in response to a study in the same journal that found lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two specific drugs subject to high-profile litigation for other adverse events (AEs).

Del Pan and Muñoz used an algorithm to identify LARs received in FAERs through the end of 2018, finding that peaks in LARs “can be attributable to highly publicized drug safety regulatory actions.”…