Partnership for Safe Medicines Interchange Speaker Announced: FDA’s Deborah Autor
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy for the U.S. Food and Drug Administration, will speak at the 2nd annual Partnership for Safe Medicine’s Interchange on October 27, 2011, at the National Press Club in Washington, DC.
Autor leads a Directorate newly created in July 2011 which includes the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP). Supervising staff of 4,000 throughout the United States from ORA and 80 in OIP around the world, she is responsible for maximizing the impact of FDA’s global interactions.
Autor leads FDA’s strategy for confronting global safety and import concerns. She co-chaired the FDA’s research effort, “Pathway to Global Product Safety and Quality.”
Her new strategy focuses on four core building blocks to keep American food and medicine secure in an increasingly global marketplace. One of the blocks is building closer partnerships with foreign counterparts, by assembling a global coalition of regulators dedicated to building and strengthening the product safety net around the world.
Prior to this new role, Autor was Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research and led an ongoing initiative to remove potentially dangerous unapproved prescription medications from the consumer market through aggressive enforcement efforts.
Under her leadership, the FDA had taken enforcement actions to remove more than 500 unapproved prescription drugs, impacting more than 275 drug manufacturers and distributors, reports the Washington Post.
Autor’s committee acknowledges that the plan is ambitious and says it will institute a “paradigm shift” in product safety and quality that is of paramount importance
“Global supply chains, international trade, foreign sourcing, and terrorism remind us daily that the rest of the world will not stop and wait for regulators to catch up.”
Hear more about Deborah Autor’s four building blocks to building safe products in a globalizing marketplace at the 2011 Interchange.
