The EMA has just concluded its year-long review of Roche’s drug portfolio following its discovery of missing safety data, amounting to tens of thousands of adverse event reports.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has been reviewing safety data on 19 centrally-authorised Roche medicines (including Tamiflu and Herceptin) as well as various nationally-authorised drugs. It discovered that the company had failed to fully assess up to 80,000 cases of possible adverse drug reactions, including 15,000 deaths.
All of this stemmed from a routine inspection of the company’s pharmacovigilance procedures by the MHRA in 2012. The inspection discovered that many reports for medicines marketed in the US had not been evaluated to determine whether they should have been reported to the EU authorities as suspected adverse reactions.
In this case, the EMA concluded that the missing data does not seem to have tipped the risk:benefit balance away from the drugs. Indeed, it stated that “Patients should continue to take these medicines as previously advised.”
All of this underlines the importance that regulatory authorities now place on pharmacovigilance – which is why Whitehall Training has a four-module online course on the subject. Most of Roche’s missing reports were from post-marketing use whereas around 600 were from clinical trials.
Roche has come clean, admitting that mistakes were made and procedures were not followed, but it insists that measures have now been put in place to ensure there is no repeat of the failings.
The company must be breathing a heavy sign of relief, although it is still being investigated based on allegations that it failed to comply with pharmacovigilance obligations relating to the 19 centrally-authorised medicines.
Watch this space…
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Blog Author: Dr. P.V. Practice
www.whitehalltraining.com
Whitehall Training provides online training courses developed to meet the learning needs of both the clinical and pharmaceutical sectors. Clients range from clinical research doctors and nurses to international Pharma companies and CROs.
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