Meet Deborah M. Autor, Esq., Deputy Commissioner for Global Regulatory Operations and Policy
Deborah M. Autor is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy. Ms. Autor’s Directorate, one of four created in July 2011, includes the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP). ORA, with a staff of over 4,000 employees across the United States, is responsible for imports, inspections, and enforcement policy for all FDA regulated products. OIP, with a staff of over 80 employees around the world, is responsible for maximizing the impact of FDA's global interactions.
Ms. Autor leads FDA’s strategy for confronting the challenges of globalization and import safety. Ms. Autor co-chaired the group that prepared FDA’s June 2011 report, Pathway to Global Product Safety and Quality, which describes the paradigm shift that FDA must make to face the challenges of globalization today and in the future.
Ms. Autor has been with FDA since 2002. Prior to assuming the role of Deputy Commissioner, she served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research. In that role, she led policy-making and enforcement for key public health programs for drugs including: current good manufacturing practices; human subject protection and bioresearch monitoring; marketed unapproved drugs; pharmaceutical import and export; pharmacy compounding; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls. Ms. Autor engaged in many international activities in this role, including leading the negotiation of the work plan under the Memorandum of Agreement between FDA and China’s State Food and Drug Administration.
Ms. Autor was recently awarded the 2011 Meritorious Executive Presidential Rank Award. This award is presented annually to a select group of career civil service senior executives whose integrity, strength, leadership, and relentless commitment to excellence in public service have earned them one of the most prestigious honors in government. Ms. Autor was also a 2010 finalist for the prestigious Service to America Medal for the innovative and strategic action that she took to tackle the serious public health issue of marketed unapproved drugs. In addition, she has received 24 awards from the Food and Drug Administration, 22 awards from the Center for Drug Evaluation and Research, one award from the U.S. Department of Health and Human Services, and six awards from the U.S. Department of Justice.
Before joining FDA, Ms. Autor was a trial attorney for seven years in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA and other federal law enforcement agencies. She began her legal career practicing food and drug law at the firms of Weil, Gotshal & Manges and Buc Levitt & Beardsley.
Ms. Autor obtained her B.A. from Barnard College of Columbia University and her J.D. magna cum laude from Boston University School of Law where she was an Article Editor for the Boston University Law Review.