EMA Clears Roche For Failing To Report Side Effects

After spending a year investigating Roche for a failure to report tens of thousands of adverse events in connection with various drugs, the European Medicines Agency has concluded its review and “has not identified any important new safety concerns.” “The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” the EMA says in a statement. The regulator adds that Roche is expected to ensure such data are included and considered in routine pharmacovigilance activities, though. The so-called “infringement procedure” was conducted by the agency’s Pharmacovigilance Risk Assessment Committe The outcome is a relief for Roche, which was greatly embarrassed last year over the disclosure. The episode began when the UK Medicines and Healthcare products Regulatory Agency found "serious shortcomings" at its Welwyn, UK, site (you can read more about the regulations here). The adverse event reports included more than 15,100 patient deaths. 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 (back story). [UPDATE: Since then, a Roche spokesman writes us, the potential number of adverse events was revised while the drugmaker implemented corrective an...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs