EMA investigates Roche
October 24, 2012
SERIOUS shortcomings in Roche’s
pharmacovigilance processes have
led to European Medicines Agency
to launch an infringement
procedure against the company.
The action marks the first time
the EMA has launched
infringement procedures against a
drug manufacturer.
The shortcomings were picked up
by UK Medicines and Healthcare
products Regulatory Agency
(MHRA) during a
pharmacovigilance inspection
carried out in May this year.
According to the allegations,
Roche failed to properly report the
side effects of 19 of its centrally
authorised EU medicines, including
Avastin, Herceptin, Tarceba,
Xeloda, and Tamiflu.
These failures included the
80,000 reports for medicines
marketed by Roche in the US
which had been collected through
a Roche-sponsored patient support
program, but which had not been
evaluated to determine whether or
not they should be reported as
suspected adverse reactions to the
European Union (EU) authorities.
According to the MHRA, these
reports included 15,161 reports of
death of patients, however it is not
known whether the deaths were
due to natural progression of the
disease or had a causal link to the
medicine.
Other issues caught by the MHRA
related to the evaluation and
reporting to national
medicines agencies of suspected
adverse reactions from their
reporting systems (around 23,000)
and clinical trials (around 600).
Despite launching the
procedures, the EMA has moved to
quell concern, saying that there is
no evidence that the drugs in
question posed a risk for patients,
but rather that the agency’s
concern was the shortfall in the
reportage of side effects.
The EMA will report the outcome
of its investigation to the
European Commission in around
18 months time.
Should Roche be found guilty the
European Commission may force it
to pay a fine of up to 5% of its EU
revenue for 2011, or to make
periodic penalty payments.
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