Regulatory Focus™ > News Articles > EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

Posted 22 June 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators.

The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection program. The company had apparently been collecting adverse event reports through a patient support program it sponsored, but had failed to evaluate the reports to determine if it was necessary to submit them to EU regulators.

The tens of thousands of reports included more than 15,000 reports of patient deaths, though EMA was quick to point out it is unknown whether patients died due to related or unrelated causes. The remaining reports include approximately 23,000 suspected adverse reactions and 600 clinical trial-related adverse events.

EMA also said it was made aware of a "smaller number of reports" than indicated by MHRA, but is still in the process of evaluating both the accuracy of the claim and whether Roche submitted adverse event reports to any EU regulators.

Members of EMA's Committee for Medicinal Products for Human use (CHMP) said they are demanding the company "ensure that all known reportable events are immediately reported to the appropriate EU authorities in accordance with their existing legal obligations" and "submit a revised comprehensive action plan" by the end of June 2012. The plan would include an evaluation of all outstanding cases and proposed corrective measures to ensure future compliance by the company.

A Roche spokesman told Reuters the company plans to have the plan submitted to regulators by January 2013.

EMA said it was continuing to work with regulatory authorities, including the US Food and Drug Administration (FDA), to evaluate the extent and impact of the alleged deficiencies and whether the benefit:risk evaluation of any Roche medicines need to be re-evaluated.

Read more:

EMA - European Medicines Agency acts on deficiencies in Roche medicines-safety reporting

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