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Following a two-year inquiry, the European Ombudsman has recommended the European Medicines Agency take several steps to ensure that private talks with drug makers about marketing applications do not influence approval decisions.

At issue are pre-submission discussions that occur between companies and the regulator, which Ombudsman Emily O’Reilly probed over concerns such talks run the risk of creating a perception of bias or that companies may somehow exert pressure on agency officials to view applications favorably.


While the talks are established practice, O’Reilly found it difficult to obtain a complete picture of how the EMA handles the exchanges. Her probe began after an unnamed drug maker issued a press release noting how agency talks were sufficiently important to report them publicly as potentially making a difference in its efforts to win approval and that EMA reviewers “signaled support” for its application.

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