EU Watchdog Agency to Review Recent EMA Actions

The European Ombudsman, Emily O’Reilly, announced an official strategic inquiry into early-stage interactions between the European Medicines Agency (EMA) and pharmaceutical companies to determine whether their interactions influenced approval decisions.

Recently, the EMA has sought to speed up the development and availability of new treatments, specifically through accelerated-approval pathways. The European Ombudsman’s probe will focus on the discussions between the EMA and pharmaceutical companies prior to submitting new drugs for review through one of the streamlined approval pathways.

In a letter to the EMA, Ms. O’Reilly stated that “such activities may pose some risks, such as that the eventual decisions by EMA on the authorization of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorization application.”

She also requested more details regarding the EMA’s pre-submission processes, a statistical overview of activities from 2012-2016, and a list of the pharmaceutical companies with which the EMA met most frequently.

Source: Reuters, July 19, 2017.