The MHRA Investigation into GSK's Reporting of Adverse Events in Seroxat Paediatric Clinical Trials

Lawyers Loretta Pugh, Tim Worden

Earlier this year, the Medicines and Healthcare products Regulatory Agency (the "MHRA") published its report into GSK's alleged failure to report in a timely manner to the MHRA certain adverse event data from clinical trials in children of its anti-depressant, Seroxat (paroxetine).  Certain data from those trials, a pooled analysis from all paediatric trials of Seroxat, suggested a causal association between the anti-depressant and an increased risk of suicidal behaviour.  The MHRA's report concluded that there was insufficient evidence to provide a realistic prospect of a criminal conviction for the alleged breach of pharmacovigilance legislation by GSK, and that there was, at the time of the alleged offences, a "significant gap in the law governing drug safety".

This article examines the MHRA report and its findings, as well as the draft UK legislation that is designed to address the gap in the law identified following the Seroxat investigation.