Posted by Michael Wonder on 23 Jul 2019
European Medicines Agency is advised to take steps to avoid bias concerns over approvals
22 July 2019 - 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 favourably.
