A coordinated European programme was recently carried out involving routine inspections of pharmaceutical companies’ safety reporting systems. Whether regulators suspected deficiencies or not is unknown, but they certainly found them when the UK’s Medicines and Healthcare products Regulatory Agency inspected one of Roche’s UK sites. During the inspection, the company identified around 80000 reports, including 15161 deaths, connected to Roche medicines marketed in the US that had not been evaluated to determine whether they should be reported as adverse drug reactions. The reports were collected through a Roche-sponsored patient programme.
At the time of writing, Roche had not published an official statement on their website in response, perhaps because the company has more important matters to attend to than press statements at the moment. The European Medicines Agency has asked the company to submit a “revised comprehensive plan” for the evaluation and reporting of all outstanding cases, as well as plans for corrective measures, by tomorrow (27 June). This includes evaluation of each of the 80000 reports and appropriate follow up. As well as the deaths, other unevaluated reports included around 23000 concerning suspected adverse reactions collected from Roche reporting systems and another 600 form clinical trials.
Of course, it is not yet known whether any of the deaths or other reports have causal relation with Roche medicines or not. No doubt all pharmaceutical companies receive thousands of reports every year, but these must all be evaluated to monitor a product’s benefit–risk balance throughout its lifecycle. The safety of a medicine is not set in stone once it has been approved by regulators as side effects or safety concern may often arise when a medicine is used in a wider population. In a statement, the EMA reiterated to Roche that the company must ensure that all known reportable events are immediately reported to the appropriate EU authorities, for both marketed products and those in clinical trials.
The EMA will be working with national medicine agencies and the FDA to investigate the deficiencies in Roche’s safety-reporting system. This includes looking at whether any of the 80000 reports impact the overall benefit–risk balance of the medicines involved.