Pharma giant failed to report 80,000 drug files - New Scientist by Andy Coghlan

An investigation is under way after the discovery that 80,000 reports of patient reactions to drugs were not passed on to regulatory authorities by the Swiss-based pharmaceutical giant Roche and its US affiliate, Genentech.

The focus of the probe, by the European Medicines Agency, is to find out whether patient safety has been compromised by the unreported information, which includes 15,000 reports of patients who ultimately died of their illnesses – although there is no evidence that their deaths were a result of the drugs they took.

"We need to determine what's going on, and have asked the companies to submit an updated corrective action plan," said a spokeswoman for the EMA. She said that companies are legally obliged to notify regulatory authorities of any adverse drug reactions (ADRs) that come to light, but stressed that until the investigation is complete, it's not clear how many of the 80,000 reports were of adverse reactions. "They are not necessarily ADRs," she told New Scientist.

The cache of buried reports was discovered last month when officials from the UK Medicines and Healthcare products Regulatory Agency visited Roche's facilities in Welwyn, UK. The EMA revealed the lapse on 21 June.

On 27 June, Roche sent the EMA a comprehensive action plan aimed at rectifying the situation and ensuring that all future reports will be properly submitted.

Roche and Genentech stress that their failure to report was not intentional. "We are taking steps to enhance our systems and controls for detecting and analysing safety data, and are evaluating further actions to prevent this from happening again," said Nadine Pinell of Genentech.

She said that no potential dangers to patients had yet been identified during an initial examination of the 80,000 buried reports. "Based on our assessments to date, no impact on the safety profiles of any of Roche's products has been found."

Roche's initial response to the exposé appears on this Pharmalot news report.

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