June 21, 2012
European regulators investigating drug-safety reporting at Roche
Last Updated:June 21, 2012 13:08
The European Medicines Agency announced Thursday that it is working with national medicines agencies to investigate deficiencies in drug-safety reporting by Roche, including whether the issues may have an impact on the overall benefit-risk profile for any of the products involved. The regulator noted that "there is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action."
The deficiencies being investigated were identified in a May report from the UK's Medicines and Healthcare products Regulatory Agency following an inspection at Roche. At the time of the inspection, approximately 80 000 reports for drugs marketed by Roche in the US had been collected through a company-sponsored programme, but had not been evaluated to determine whether they should be reported as suspected adverse reactions to the EU authorities. These included 15 161 reports of patient death, although it is not yet clear whether the deaths were linked to the drugs in question or due to natural disease progression. The EMA noted that more recent information from the drugmaker indicates a smaller number of reports, but this information needs to be verified by the authorities, and it also remains unclear whether any of the reports have already been submitted in Europe through other channels.
Other deficiencies identified related to the evaluation and reporting to national medicines agencies of approximately 23 000 suspected adverse reactions from their reporting systems and around 600 from clinical trials.
The EMA noted that going forward, Roche will ensure that all known reportable events are immediately submitted to the appropriate EU authorities and the company must confirm with the agency that this has been done, both for medicines in clinical trials and for marketed products. In addition, the drugmaker has been asked to 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 on suspected adverse drug reactions in the future. The EMA said that this includes the evaluation and appropriate follow-up of the 80 000 reports received by the patient support programme in the US.
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