EMA Watchdog to Investigate Possible Bias in Pre-Submission Process

The European Medicines Agency’s watchdog is investigating whether companies may be using pre-submission meetings to unduly influence the agency.

European Ombudsman Emily O’Reilly, who has scheduled a meeting in September to review the matter with EMA, said it is equally important that the public not perceive the pre-submission meetings as influencing the agency.

O’Reilly cited a press release by an unnamed company implying the company had received favorable indications from the EMA, which could create the perception of bias, she said, adding she plans to discuss the possibility of publishing basic information about pre-submission activities.