Rachel E. Sherman
Rachel E. Sherman, M.D., is the Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA). On behalf of the Commissioner, she provides leadership, management and policy direction in planning and implementing major cross cutting medical product policy and programmatic initiatives that are clinical, scientific or regulatory in nature. Her areas of focus include establishing the Oncology Center for Excellence and the Combination Products Policy Council as well as oversight for the EvGen initiative; the Offices of Good Clinical Practice, Orphan Products Development, and Pediatric Therapeutics; and modernization of Advisory Committee practices. Most recently, Dr. Sherman served as Associate Deputy Commissioner for Medical Products and Tobacco from October 2015 until September 2016. Dr. Sherman brings more than 25 years of dedication to the public health. Areas of focus include medical product development, communication of medication information, and clinical care. During her previous tenure at FDA (1989 to 2014), she served in a variety of roles, ranging from primary FDA medical reviewer during the AIDS crisis to member of the Executive Leadership Team in FDA's Center for Drug Evaluation and Research (CDER). From 2009 to 2014, Dr. Sherman served as CDER's Associate Center Director for Medical Policy and directed CDER's Office of Medical Policy. She established and led a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including the Sentinel initiative; FDA's program for regulating biosimilars; and the Agency's expedited drug development and breakthrough therapy designation programs. She organized multi-stakeholder public private partnerships; oversaw development of regulations and guidance for industry; and played a key role in enhancing clinical trial quality and good clinical practice. Her achievements contributed directly to more effective prescription drug promotion and to the modernization of professional drug labeling, generic drug labeling, and medication information for patients. From 2014 to 2015, Dr. Sherman continued her focus on the development of innovative therapies in her role as Principal, Drug and Biological Drug Products, at Greenleaf Health LLC, a consultancy that provides strategic and technical assistance, with an emphasis on medical product development. Dr. Sherman is an internist with a subspecialty in infectious diseases. She received her MPH from Johns Hopkins University, her MD from Mount Sinai School of Medicine, and her BA in mathematics from Washington University in St. Louis. She has served over the years as attending physician, Division of Infectious Diseases, at the Veterans Affairs Medical Center; clinical assistant professor of medicine (infectious diseases) at Georgetown University; and volunteer physician with Montgomery Mobile Health.