* 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 Europe's main drugs regulator has
found no new safety issues linked to Roche medicines
after an investigation into the Swiss drugmaker, which was
rapped last year for lax drug-safety reporting.
The Swiss drugmaker could, however, still face a substantial
fine for not properly reporting drug side effects.
The European Medicines Agency (EMA) launched a probe into
Roche in June 2012 after a routine inspection found it had
failed to properly assess tens of thousands of cases of possible
adverse drug reactions.
The investigation included 19 centrally approved drugs,
several of which were for cancer. Roche is the world's largest
maker of cancer medicines, as well as producing drugs for viral
infections and inflammatory diseases.
Drugmakers are required to evaluate problems reported by
doctors and patients after taking their drugs, and then pass on
any serious cases to regulators. The Roche inspection found many
of these reports had not been properly assessed by the company.
The EMA initially put the potential number of unreported
adverse events at 80,000, but this figure has since been revised
down to around 23,000, a Roche spokesman said.
The large number of unreported cases led to concerns that
there might be unforeseen safety issues with some of Roche's
medicines, which include widely used brands such as Avastin and
Herceptin in cancer and influenza pill Tamiflu.
In the event, the EMA said its thorough review of drugs made
by Roche had not identified any important new safety concerns.
"The balance of benefits and risks of these medicines has
not been affected and there is no new advice regarding their
use. Patients should continue to take these medicines as
previously advised," the agency said in a statement.
Roche may still face fines for failing to comply with
so-called "pharmacovigilance" obligations under a separate legal
investigation that commenced in October 2012.
If found guilty, it could be fined up to 5 percent of ITS
annual 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-based
EMA has launched such a legal review since new legislation came
into force six years ago.
The Basel-based drugmaker said it had put in place
corrective actions concerning the collection, processing,
evaluation and reporting of adverse event data.
The unusually wide-ranging investigation into Roche's
medicines was triggered by a routine check of a Roche facility
in Britain, which found it had not properly evaluated thousands
of reports linked to a company-sponsored patient support
programme dating back to 1997.
These cases included a significant number of deaths, which
may or may not have been linked to the medicines.
Adverse drug reporting is designed to catch potential
problems with medicines by setting a requirement for
notification 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 Drug
Administration (FDA) - routinely carries out pharmacovigilance
inspections to make sure drug companies are reporting incidents