Why is one of the biggest pharmaceutical companies delaying to report tens of thousands of adverse event reports to the European Medicines Agency (EMA)? According to various news reports, the EMA intends to find out.
Europe’s drug regulator has started an infringement procedure against Switzerland’s Roche to investigate its alleged failure to properly report as many as 80,000 potential drug side effects, involving nineteen different drugs, many of them used for the treatment of cancer, including breast cancer.
If found guilty, the world’s biggest maker of cancer medicines could be fined up to 5 percent of annual EU turnover which totals approximately $13.8 billion in 2011.
It was first time the London-based European Medicines Agency (EMA) has launched such proceedings since legislation came into force five years ago.
In a statement, the European Medicines Agency said it will further investigate the allegations against Roche.
“We issued Roche with a detailed letter setting out the allegations against them and they now need to respond,” said Martin Harvey Allchurch, a spokesman for the agency.
He said the agency had 18 months to finish its investigation. It will then be up to the European Commission to decide whether Roche should be penalized.
“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 stated.
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.
The EMA also said all Roche’s medicines remained authorized without changes to the treatment advice for patients and doctors, since there was no indication of “a negative impact on the benefit-risk balance” of the drugs.
Roche said it was going through all the cases to check which incidents should have been classified as possible adverse reactions, adding that some may already have been submitted to regulatory authorities through different channels, including by doctors looking after patients.
A company spokesman said it was premature to speculate on the outcome of the EMA investigation and the possibility of a fine, but he noted that Roche had provisions for various risks.[hr]