In no uncertain terms, the European Medicines Agency is trying to reassure the European Ombudsman that private talks with drug makers about marketing applications do not influence approval decisions.
The regulator is on the defensive after Ombudsman Emily O’Reilly two months ago opened an inquiry into so-called pre-submission discussions that occur between drug makers and the regulator. Her move reflected concerns such talks run the risk of creating a perception of bias or companies may somehow exert pressure on agency officials to view applications favorably.
But in an Aug. 29 reply, which the Ombudsman only just released late last week, the EMA maintained that such preliminary discussions serve a legitimate purpose. And while acknowledging that risks do exist, EMA director Guido Rasi insisted the agency takes the necessary steps to avoid bias or conflicts that may otherwise arise as part of the process.
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I don’t understand this. I’ve been a part of many of these discussions and it’s a chance for sponsors and regulators to collaborate so a trial can satisfy both regulatory and sponsor aims. It’s a chance for sponsors to ask if their 8 or 9-$ figure trial will produce outcomes regulators want to see. How can government “regulate” without interacting? And trust me — I’ve never seen sponsors inappropriately sway regulators — in fact by the time the trial is over and submitted it’s usually a new cohort of regulators who evaluate the submission package.
Hi JC
I’m not privy to O’Reilly’s files, so not sure what prompted her to pursue this, only that she has been after EMA to be more transparent about everything. She tussled with them over releasing trial data and, my impression is she was less than impressed with how the agency handled court cases brought by two drug makers. And so she’s looking under another rock. What if anything she might find, I just don’t know. You make a good point.
Regards
ed at pharmalot