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Roche rapped by EMA for safety reporting failures

Inspection finds 80,000 reports on medicines not properly assessed to determine if they were adverse events

Swiss pharma company Roche is being investigated by the European Medicines Agency (EMA) and other national regulators after an inspection found it failed to properly assess thousands of reports of adverse reactions which could have been linked to its products.

The EMA was quick to point out that there is no evidence of any negative consequences for patients as a result of the reporting deficiencies, which were identified during a routine inspection of Roche's facility in Welwyn, UK.

The inspection team from the UK Medicines & Healthcare products Regulatory Agency (MHRA) found that 80,000 reports for medicines marketed by Roche and subsidiary Genentech in the US had been collected through a patient support programme, but these "had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities".

The tally included more than 15,000 reports of patient deaths, although the EMA stressed it is not known whether these were linked to the drug treatment or the natural progression of the patients' disease.

Other discrepancies related to the evaluation and reporting to national medicines agencies of some 23,000 suspected adverse reactions, as well as 600 relating to clinical trials.

A strongly worded statement from the EMA notes that Roche has been ordered to communicate all reportable events to the appropriate EU authorities - both for products in clinical trials and on the market.

It has also been instructed to submit an action plan by June 27, 2012, to remedy the situation, including the 80,000 outstanding reports from the US patient support programmes.

Roche acknowledged its non-compliance with regulations in a statement, but said it was "not intentional". The company insisted it is "committed to actively pursuing corrective and preventative actions" to address the matter.

 "Based on our assessments to date, no impact on the safety profile of any of its products has been found," it said.

That assessment was echoed by the MHRA chief executive Professor Sir Kent Woods, who cautioned that patients taking Roche medicines should not stop taking them "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," he added.

"We are taking urgent action to ensure that these are rectified by Roche as a matter of priority."

22nd June 2012


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