EU clears Roche drugs after probe into lax safety reports


* EMA finds no new safety issues with approved Roche drugs

* Follows major review prompted by lax drug-safety reporting

* Roche says has acted to improve adverse event data systems

* Roche could still face fine under separate legal review

By Ben Hirschler

LONDON, Nov 19 (Reuters) - Europe's main drugs regulator hasfound no new safety issues linked to Roche medicinesafter an investigation into the Swiss drugmaker, which wasrapped last year for lax drug-safety reporting.

The Swiss drugmaker could, however, still face a substantialfine for not properly reporting drug side effects.

The European Medicines Agency (EMA) launched a probe intoRoche in June 2012 after a routine inspection found it hadfailed to properly assess tens of thousands of cases of possibleadverse drug reactions.

The investigation included 19 centrally approved drugs,several of which were for cancer. Roche is the world's largestmaker of cancer medicines, as well as producing drugs for viralinfections and inflammatory diseases.

Drugmakers are required to evaluate problems reported bydoctors and patients after taking their drugs, and then pass onany serious cases to regulators. The Roche inspection found manyof these reports had not been properly assessed by the company.

The EMA initially put the potential number of unreportedadverse events at 80,000, but this figure has since been reviseddown to around 23,000, a Roche spokesman said.

The large number of unreported cases led to concerns thatthere might be unforeseen safety issues with some of Roche'smedicines, which include widely used brands such as Avastin andHerceptin in cancer and influenza pill Tamiflu.

In the event, the EMA said its thorough review of drugs madeby Roche had not identified any important new safety concerns.

"The balance of benefits and risks of these medicines hasnot been affected and there is no new advice regarding theiruse. Patients should continue to take these medicines aspreviously advised," the agency said in a statement.


Roche may still face fines for failing to comply withso-called "pharmacovigilance" obligations under a separate legalinvestigation that commenced in October 2012.

If found guilty, it could be fined up to 5 percent of ITSannual EU turnover, which totalled 12.8 billion Swiss francs($14 billion) in 2011, or 640 million francs.

The Roche case marks the first time that the London-basedEMA has launched such a legal review since new legislation cameinto force six years ago.

The Basel-based drugmaker said it had put in placecorrective actions concerning the collection, processing,evaluation and reporting of adverse event data.

The unusually wide-ranging investigation into Roche'smedicines was triggered by a routine check of a Roche facilityin Britain, which found it had not properly evaluated thousandsof reports linked to a company-sponsored patient supportprogramme dating back to 1997.

These cases included a significant number of deaths, whichmay or may not have been linked to the medicines.

Adverse drug reporting is designed to catch potentialproblems with medicines by setting a requirement fornotification when a patient dies or suffers a medical setback -even if this may be due to their underlying disease.

The EMA - the equivalent of the U.S. Food and DrugAdministration (FDA) - routinely carries out pharmacovigilanceinspections to make sure drug companies are reporting incidentsproperly.

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