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Roche Facing Fine Over Lax Drug Safety Reporting

Filed October 26th, 2012 Laurie

Roche Holding AG faces a massive fine as European health regulators investigate whether or not the pharmaceutical company failed to fully report tens of thousands of adverse drug reactions.

The world’s biggest maker of cancer drugs could be forced to pay as much as five percent of its annual turnover to the European Union (EU), Reuters reported. The issue first arose back in June when British investigators discovered the firm had failed to properly analyze up to 80,000 cases of possible adverse drug reactions. The medications involved are linked to a financial reimbursement system here in the United States.

Adverse events for 19 drugs are now under the microscope of regulators, including the popular cancer treatments Herceptin and Avastin, and the flu symptoms reliever, Tamiflu.

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