September 10, 2010 - RADM Sandy Kweder, M.D. is the Deputy Director of CDER's Office of New Drugs (OND) for the United States Food and Drug Administration. She is also an Associate Professor of Medicine at the Uniformed Services University of the Health Sciences.
Dr. Kweder's seminar, “Drugs and FDA: Demystifying the Interface of the Science and Public Policy” lived up to its name on September 10, 2010. RADM Kweder offered CRND students a window into the world of the Food and Drug Administration and thanks to her contagious enthusiasm, students enjoyed a lively question and answer session on the origins of the FDA, its mission, inner workings and achievements. Dr. Kweder's historical overview of the agency captivated students with real life stories about the food scandals brought to light by Upton Sinclair in The Jungle , patent medicine frauds, cosmetic disasters, and the names of dangerous and ineffective drugs that made headlines in their day. Students were able to connect the evolution of the agency and its science-based protocols with the kinds of problems public welfare agencies have faced for over a century in protecting consumers.
Dr. Kweder outlined the current infrastructure of the FDA with 5 centers in Washington concerned with drug evaluation and research, biologics evaluation, medical devices and radiologic health, food safety and nutrition, and veterinary medicine. She discussed the167 field offices around the country and 12,000 healthcare professionals, numbering physicians, chemists, pharmacologists, toxicologists, statisticians, microbiologists, clinical safety experts, and plant inspectors.
Of particular interest to students in the course, were Dr. Kweder's oversight activities regarding the team for Study Endpoints and Labeling Development. She reviewed the FDA's procedures for Investigational New Drug Development Applications, including reporting on chemical composition, animal studies, clinical trials, endpoint development and ongoing surveillance. Students learned about the Orphan Drug Act that supports drug development for rare diseases and creates financial incentives to balance the enormous investments required for drug discovery and testing. Dr. Kweder clarifiied some of the hurdles for Orphan drugs to demonstrate evidence of effectiveness, clinical benefit and safety. Rare disease studies have special difficulties because they must draw upon very small and medically fragile populations.
Finally, Dr. Kweder offered students several pearls on career development, relating her own story of being commissioned in the US Public Health Service, studying public health, progressing to medicine, and serving in a variety of roles in the FDA.