Roche may face fines over drug-safety reporting

LONDON (Reuters) - Europe's drug regulator has started an infringement procedure against Switzerland's Roche to investigate its alleged failure to properly report tens of thousands of potential drug side effects.

If found guilty, the world's biggest maker of cancer medicines could be fined up to 5 percent of annual EU turnover which totaled 12.8 billion francs ($13.8 billion) in 2011, or 640 million francs.

It was first time the London-based European Medicines Agency (EMA) has launched such proceedings since legislation came into force five years ago.

"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 on Tuesday.

The issue of drug-safety reporting by Roche was first highlighted by the agency in June after a routine inspection by British investigators found it had failed to fully assess up to 80,000 cases of possible adverse drug reactions.

There were some 15,000 deaths among the reports, which may have been due to natural disease progression but may have been connected to the drugs.

That led to an immediate probe into public health implications. The latest investigation is into the separate matter of whether Roche complied with its legal obligations. The two inquiries will run side by side, an EMA spokeswoman said.

The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system designed to help U.S. patients who could not afford to pay for Roche's drugs without outside assistance.

Roche said it was cooperating with health authorities, adding that, to date, no impact on the safety profiles of any of its products had been found.

NO INDICATION

See the original post:
Roche may face fines over drug-safety reporting