Are pre-submission meetings influencing EMA’s decisions on MAAs?

The European Medicines Agency’s (EMA) is under investigation by European Ombudsman, Emily O’Reilly after she raised concerns that EMA’s pre-submission meetings with sponsors could influence the agency’s decisions about marketing authorisations (MAs). O’Reilly has begun the process of gathering evidence after writing to the Executive Director, Guido Rasi, at the EMA. In the letter, O’Reilly set a date in September by which she expect EMA to address a list of questions to aid the strategic enquiry.

O’Reilly believes that public perception is important; this position, in part, is based on a press release about an MA submission from a drug developer who promoted discussions with EMA and suggested receiving support for the application from rapporteurs.  Perhaps this information was designed to provide assurance to the companies investors, but it bothered O’Reilly; her concerns are that the public may view this as bias so she is asking EMA to take proactive measures to reduce such perceptions.

In the letter to Rasi, O’Reilly’s questions have a strong focus on transparency and include the possibility of EMA publishing detailed minutes of pre-submission meetings. The letter also raises questions on the rules governing contact between Rasi’s staff and manufacturers, and whether it allows the marketing authorization decision makers at EMA to participate in pre-submission meetings and whether there are sufficient checks in place to ensure decisions are objective.

To access the full letter from the European Ombudsman, please click here.