Swiss drug giant Roche has found itself under the close scrutiny of European officials who are investigating its practices surrounding drug safety reporting.
The European Medicines Agency has announced that it is working with national medicines agencies to investigate "deficiencies" in the drugmaker's medicine-safety reporting system.
In particular, it is looking at whether any failings in the system have affected the overall benefit-risk profile for any of the products involved.
The deficiencies were first highlighted in a report last month by UK watchdog the Medicines and Healthcare products Regulatory Agency, following a routine inspection of drug safety reporting systems which is currently underway in Europe.
This found that Roche had identified some 80,000 reports for medicines it markets in the USA that had been collected through a Roche-sponsored patient support programme, but which had not been evaluated for suspected adverse reactions and whether EU regulators should be informed.
According to the EMA, these reports included 15,161 patient deaths that could be due to natural progression of the disease but also might have a causal link to the medicine. (It did stress that more recent information from the company indicates a smaller number of reports, but that this information remains unverified.)
In addition, other deficiencies were identified relating to the investigation and reporting to national regulators of suspected adverse reactions from the company's reporting systems (around 23,000) and clinical trials (around 600).
Action taken
The EMA is now working alongside the US Food and Drug Administration to help assess the overall public health impact of the findings and whether or not there are any consequences for the overall benefit-risk balance of the involved medicines.
In the meantime, it said Roche must ensure that all known reportable events relating to marketed medicines or those in clinical trials are immediately reported to EU authorities, as well as submit a revised comprehensive action plan by June 27 for the evaluation and reporting of all outstanding cases and plans for corrective measures to ensure the correct processing of reports in future.
