Theresa M. Mullin directs strategic programs including business informatics for CDER. The Office of Strategic Programs plays a lead role in a number of CDER’s strategic initiatives and modernization efforts including development of benefit-risk and other decision support tools, the international program, data standardization, lean management, program analysis, informatics, and major user fee negotiations.
Dr. Mullin currently leads the CDER Patient Focused Drug Development Initiative and the FDA delegation to the International Conference on Harmonization. She is serving as FDA lead negotiator for the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization, having similarly led negotiations for 2012 PDUFA V and BSUFA authorizations. PDUFA currently generates nearly $800 million in fee revenues to support the process of human drug review.
Before joining CDER in September 2007, Dr. Mullin was Assistant Commissioner for Planning in the FDA Office of Commissioner. In that role she led previous FDA user fee negotiations with the pharmaceutical industry for the 2007 and the 2002 reauthorizations of PDUFA. Since joining FDA Dr. Mullin has received the Senior Executive Service Presidential Rank Award for Meritorious Service in 2006 and for Distinguished Service in 2011.
Before coming to FDA, Dr. Mullin was a Senior Manager with The Lewin Group, specializing in health care consulting, and prior to that, Principal Scientist at Decision Science Consortium, specializing in decision research and analysis. Dr. Mullin received her B.A., magna cum laude, in Economics from Boston College, and Ph.D. in Public Policy Analysis from Carnegie-Mellon University.