Sharon Terry on PDUFA

This is not rocket science!  Running a molecule through all of the traps is really hard.  Understanding what people feel and think and experience with regard to the drugs they take and those they need is simple.  In most other areas of our lives, various industries know quite well what features we want on our smartphones, that we suddenly all want Greek yogurt, and that we don’t want to pay to use the bathroom on a plane.  In medicine, we have not yet realized the same dynamic and robust methods, tools and studies for understanding the needs and values of the end user.  The needs, wants, values and goals of the end user are a point of emphasis that is lacking in the current medical, drug development, and regulatory review systems.  Yet, there are countless unmet medical needs that need to be addressed in a way that meets the need from the viewpoint of the people with the need.  We must work together in a coordinated, collaborative and focused way to create a system that is dedicated to achieve the shared goal of a more efficient drug development and regulatory review process through advancements in the science of patient input.  I believe that those entities in the ecosystem that believe that the consumers of healthcare can actually be active participants can collaborate to advance the critical science of patient input.  Collaborators must include those who have most frequent encounters with individuals including healthcare providers, pharmacists, schools, communit...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news