EMA Investigates Roche for Deficiencies in Safety Reporting

Jun 28, 2012

The European Medicines Agency (EMA) has launched an investigation into Roche after an inspection found that thousands of potential safety reports connected to Roche medicines, including reports of 15,161 deaths, had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

According to the inspection, which was conducted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of a coordinated European program of routine inspections concerning safety-reporting systems, Roche identified around 80000 reports that had not been evaluated. The reports were collected through a Roche-sponsored patient support program and relate to products marketed by the company in the US. As well as deaths, suspected adverse reactions were also unevaluated, including approximately 23000 reports gathered through Roche’s reporting systems and 600 from clinical trials.

It is unclear whether any of the reports have already been submitted to authorities through other channels, such as healthcare professionals, whether the deaths or suspected adverse effects have any causal link to Roche’s products. In addition, the EMA explained in a statement that more recent information from the company indicates that there may be a smaller number of deaths, although this has yet to be verified by regulatory authorities.

The EMA will work with national medicines agencies, including FDA, to investigate the deficiencies and will also examine whether the safety reports have any impact on the overall benefit-risk profile of the medicines involved. In the meantime, Roche have been told to submit a revised comprehensive action plan for evaluating and reporting all outstanding cases, as well as plans for corrective measures to ensure adequate reporting by Wednesday 27 June.

The EMA also reiterated that Roche must ensure that all known reportable events are immediately flagged to the appropriate authorities, both for products in clinical trials and for marketed products.

In a statement released by the MHRA, Sir Kent Woods, chief executive of the MHRA, said: "Patients should continue to take their medicines because our investigation into Roche has currently found no evidence of a safety risk to patients. Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate. We are taking urgent action to ensure that these are rectified by Roche as a matter of priority.”

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