The European Union is investigating whether presubmission meetings with the EMA enable drug companies to influence marketing authorization approval decisions. Officials at the EMA must now allay concerns their meetings with sponsors introduce a source of bias into their decision-making.
Drug companies meet with the EMA to discuss their drugs and development programs throughout the R&D process. The EMA sees such meetings as facilitating the speedy development of safe and effective medicines, leading it to make early, frequent engagement a cornerstone of its initiatives to cut the time it takes to get innovative drugs to patients.
Yet, the EU’s watchdog sees a potential dark side to these meetings. While the EMA uses meetings to influence drug development programs, sponsors may be using them to influence later decisions by the EMA.
“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,” Emily O'Reilly, the European ombudsman, wrote.
O'Reilly made that claim in a letter to EMA chief Guido Rasi that kicked off her investigation into his organization. To justify the need for the probe, O'Reilly pointed to a press release put out by an unidentified company when it filed for EMA approval. The release reportedly discussed interactions between the company and the EMA, going as far as to claim the rapporteurs handling the case had indicated their support for the application.
As O’Reilly sees it, this is a problem. Even if the EMA ensures its decisions are objective, members of the public could see the press release as evidence of bias. And as building trust between citizens and EU institutions is a long-standing goal of the ombudsman, O’Reilly thinks this perceived bias is worth investigating.
O’Reilly wants to meet with the EMA to discuss the topic in September. To help the EMA prepare for the meeting, O’Reilly lists 11 questions in her letter to Rasi. These cover the presubmission process and its use by sponsors, before delving into more specific topics. O’Reilly wants to know what rules govern contact between EMA staff and sponsors, whether it publishes detailed minutes of presubmission meetings and how it tries to prevent its comments constituting a pre-evaluation of data.
The investigation opens another front in O’Reilly’s monitoring of the EMA’s relationship with the industry it regulates. O’Reilly investigated the link between AbbVie and the tightening of the EMA’s policy on trial data transparency in 2014. Four months after O’Reilly began the probe, the EMA revised its policy to make data more accessible to researchers.