At the time of the inspection, some 80,000 reportsfor medicines marketed by Roche in the United States were identified that hadbeen collected through a Roche-sponsored patient support program but which reportedly hadnot been evaluated to determine whether or not they should be reported assuspected adverse reactions to the European Union (EU) authorities. Some of thereports date back to 1997.
It remains unclear whether any of the reports havealready been submitted to the EU authorities through other channels, forexample by the treating healthcare professionals; the investigation by the EMAwill examine whether the safety reporting deficiencies have had any impact onthe overall benefit-risk profile for any of the products involved.
However, the EMA stresses that at this time, thereis no evidence of a negative impact for patients, and it has expressed that whilethe investigations are being conducted, there is no need for patients orhealthcare professionals to take any special actions with regard to use ofRoche medicine.
The reports that were identified included 15,161reports of death of patients, but the EMA says that it is too early to knowwhether those deaths were due to natural progression of the disease or had acausal link to the Roche medicines in question.
Roche has indicated that the reports of deaths aresmaller in number than the EMA has stated, but authorities are still verifyingthe specifics.
One action that the EMA will be pursuing is towork toward Roche ensuring that all known reportable events are immediatelyreported to the appropriate EU authorities in accordance with their existinglegal obligations. The EMA will be requiring that Roche confirm this reportingwith it, both for products in clinical trials and for marketed products.
Also, Roche was to submit a revised comprehensiveaction by June 27 for the evaluation and reporting of all outstanding cases andplans for corrective measures to ensure the correct processing of reports onsuspected adverse drug reactions in the future. This includes evaluation ofeach of the 80,000-plus reports received by the patient support program in the UnitedStates and appropriate follow-up.
While such pharmacovigilance inspections areroutine, an EMA spokesperson has confirmed to the media that the fairlyhigh-profile and public nature of this dressing-down isn't typical, reflectinga goal of ensuring that there aren't any systemic problems at Roche.
Roche has noted that it expects by January toprovide its final count of the number of adverse events it seems to have failedto report to health authorities.
"Roche acknowledges it did not fully complywith regulations and appreciates the concerns that can be caused by this issuefor people using its products," the company noted, adding, "Roche iscommitted to actively pursuing corrective and preventative actions to addressthis matter expeditiously. The non-reporting of these potentially missedadverse events was not intentional."
In the category of more traditional bad news fromthe EMA, Pfizer around the same time as the Roche news got word from Europeanregulators that it will not get approval for Elelyso, a new treatment forGaucher disease that was approved in the United States in May and is intendedto be a rival for Sanofi's Cerezyme and Shire's Vpriv.