Roche failed to investigate 80,000 safety incidents
pharmafile | June 25, 2012 | News story | Manufacturing and Production, Sales and Marketing | EMA, MHRA, Roche, pharmacovigilance
The European Medicines Agency is investigating Roche after ‘deficiencies’ in the manufacturer’s pharmacovigilance processes came to light.
It has emerged that 80,000 incidents involving Roche medicines in the US have not been evaluated to see whether they should have been reported as adverse reactions to European Union authorities.
These included 15,161 patient deaths – it is not known whether the deaths were natural or had a link to the drug they were taking.
The EMA is now looking at whether patients have been put in danger as a result of Roche’s failings – although the regulator says there is no evidence for that at present.
The UK drug regulator the Medicines and Healthcare Products Regulatory Agency discovered the problems following a routine inspection of Roche’s systems during January and February this year.
Roche insists that the failure to report adverse events was ‘not intentional’ and that it is taking steps “to address the findings of the MHRA inspection”.
The company has provided initial estimates of missed adverse events and is ‘in the process of’ confirming the final number, which the EMA will then check.
“Patient safety is of paramount importance,” said the manufacturer in a statement. “We acknowledge the concerns that can be caused by this issue for people using our medicines.”
The EMA now requires Roche to ensure all known reportable events are immediately reported to EU authorities “in accordance with their existing legal obligations”.
The manufacturer must confirm that this has been done for products in clinical trials as well as medicines on the market.
Roche also has until 27 June to explain how it is going to deal with all the outstanding cases – including the 80,000 incidents in the US – and ensure that things are handled correctly in the future.
The company said everything will be completed ‘as soon as possible’ and the EMA has made clear that there is no need for patients or doctors to do anything at the moment.
Adam Hill
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