Gaining regulatory approval as quickly and smoothly as possible is obviously the number one goal for sponsors as they submit their NDA, BLA, or PMA to regulatory authorities including the FDA and EMA. A regulatory submission is the one time when the data don’t speak for themselves – and it’s no time to make mistakes. The reality is that even the best sponsor teams run the risk of falling in love with their data and “drinking their own Kool-Aid.” The good news is there are ways to avoid this common pitfall.
The Center for Devices and Radiological Health (CDRH) has followed the advice of Advisory Committees to approve or not approve a product 89% of the time. Using the resources of our firm, 3D Communications, the authors conducted a survey of current and former members of FDA Medical Device Advisory Committees to determine how they prepare and the key factors that influence their thinking.
Recognizing the value of patient insights in drug development, FDA has made great efforts to integrate patient perspectives into its benefit risk framework for a number of disease areas through the Patient-Focused Drug Development (PFDD) program, an initiative of the Prescription Drug User Fee Act (PDUFA) V of 2012. One of the common points patients shared at the PFDD workshops held over the past two years is the feeling that their “chief complaints” or needs are not being factored into drug development plans, including measures of a drug’s benefit in clinical trials. To get an inside read on why this may be occurring and what can be done to correct it, we spoke with representatives from the Obesity Action Coalition, the IBD Support Foundation, and the Arthritis Foundation, all of whom are actively engaged in giving a voice to patients in their communities and improving access to optimal care. They shared their perspectives on how the role of patients has evolved in the past decade and what can be done in the future to better factor patients’ feedback into drug development and access planning.
The debate format plays to Hillary’s strengths. Unlike large stump speeches, where she has to be heard over a roaring crowd, here she had a microphone, an attentive quiet crowd, and the floor to herself when responding to questions. She didn’t have to yell or even raise her voice. She already had years of experience, having done 25 debates to her opponents’ zero. But most importantly – and I cannot stress this enough — Hillary is a classic over-achiever, and she prepares like nobody else.