The European Medicines Agency has launched an ‘infringement procedure’ into Roche’s alleged failure to comply with drug safety reporting standards, leaving the drugmaker at risk of a potentially hefty fine.
The investigation will assess whether the Swiss drug giant failed to comply with its legal obligations surrounding the reporting of drug side effects, for no less than 19 of its medicines – including the cancer giants Herceptin (trastuzumab) and Avastin (bevacizumab) – licensed for use in the region.
The probe follows an inspection in May by the UK Medicines and Healthcare products Regulatory Agency, “which identified serious shortcomings of Roche’s pharmacovigilance processes,” the Agency said.
At the time, some 80,000 reports for medicines marketed by Roche in the US collected through a company-sponsored patient support programme had not been assessed to determine whether they should be reported as suspected adverse reactions to European authorities.
There were also deficiencies relating to the evaluation and reporting to national medicines agencies of suspected adverse reactions via the company’s reporting systems (around 23,000) and clinical trials (around 600).
Second investigation
These findings already prompted an earlier – and still ongoing – investigation by the Agency into medicine-safety reporting systems at the firm, including whether the deficiencies have affected the overall benefit-risk profile for any of the products involved.
The outcome of this latest, separate, legal probe will be reported to the European Commission, which may impose fines or periodic penalty payments – potentially up to 5% of Roche’s EU sales in the preceding year, according to Bloomberg – should it conclude that the group has infringed its obligations.
