Mattia Andreoletti

My research has been organized around two overlapping questions: (1) whether and how the current approach to the regulation of new medicines should be modified to manage issues generated by new biomedical products, and (2) whether this issue may be reduced to an epistemological and methodological analyses. First of all, there is no way to tackle the issue of changing drugs regulation exclusively from an epistemological perspective. Epistemological and methodological considerations are important, but nonetheless the financial and political issues at stake in drug regulation are enormous. Thus, any epistemological analysis taken out of context cannot make any addition to current debates. Secondly, we must be aware that scientific landscape is rapidly and constantly changing. The molecular revolution in biomedicine makes urgent and crucial to reconsider a regulatory system that has been put in place to regulate products which were essentially different. We should as well take very seriously the fears of the potential negative consequences of adopting looser regulatory standards of evidence, especially because so far RCTs have offered a reasonable level of safety to patients. The good news, in our view, is that there is room for changes without losing much safety for population. The bad news is that changes for the better would require a more systematic and collective effort, which might be beyond any political and academic willingness.