European Medicines Agency Probes Roche for Reporting Failures

Three months after the European Medicines Agency found that Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths, the agency is now initiating what its calls an infringement procedure at the request of the European Commission. The move means that Roche faces financial penalties if the EMA finds violations of pharmacovigilance obligations which, in this case, involved reporting side effects concerning 19 marketed drugs. The episode began when the UK Medicines and Healthcare products Regulatory Agency found “serious shortcomings” at its Welwyn, UK, site. As we reported previously, at the time of the inspection, Roche identified some 80,000 reports for medicines marketed in the US that had been collected through its patient support program, but these had not been evaluated to determine whether they should have been reported as suspected adverse reactions to EU authorities.