EMA probes Roche for faulty side-effects reporting

Did Roche ($RHHBY) bungle tens of thousands of adverse-event reports? European regulators aim to find out. The European Medicines Agency says it has started an "infringement procedure" against the Swiss drugmaker, to probe allegations that it dragged its feet on reporting potential side effects.

British inspectors first flagged the issue in June, when they found Roche hadn't properly handled up to 80,000 adverse-event reports. A laundry list of drugs was involved, including the cancer drugs Avastin, Tarceva and Herceptin; the influenza pill Tamiflu; and the anti-HIV drugs Viracept and Invirase. Inspectors said Roche had not reviewed the case reports to determine whether they should be passed along to EU authorities.

If EMA finds that Roche fell short of its obligations, it could be fined by the European Commission--at amounts up to 5% of its annual sales in Europe, Reuters reports. "The agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments...if it finds that Roche has committed an infringement of its obligations," the EMA said in a statement.

- see the EMA release
- get more from Reuters

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