The Commissioner of the United States Food and Drug Administration, Margaret Hamburg will provide the keynote address to the O’Neill Institute for National and Global Health Law’s Summer Program on Emerging Issues in Food and Drug Law.
Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.
As the top official of the Food and Drug Administration (FDA), Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. “Strengthening FDA’s programs and policies will help us protect the safety of the food supply, give the public access to safe and effective medical products, find novel ways to prevent illness and promote health, and be transparent in explaining our decision-making,” says Dr. Hamburg. “A strong FDA is an agency that the American public can count on.”
Dr. Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.
From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundation’s vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.
In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.
From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position, she improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, and initiated the nation’s first public health bioterrorism defense program. Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburg’s reforms, New York City’s TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients’ homes to make sure they completed the drug regimen, is now a model for health departments worldwide.
The program will cover U.S. domestic law including recent laws and regulations; international regulatory harmonization and mutual recognition efforts now under way between major exporting and importing countries; and the increasing influence of trade and investment rules. The program will convene leading academics, practitioners, and regulators to inform participants not only what the law is now, but which forces will shape its future. Additional information can be found here.
Professor Sam Halabi (HAL uh bee), J.D., M.Phil., is an O’Neill Institute Scholar and an Associate Professor at the University of Tulsa College of Law. From 2008 to 2010, he was a law fellow at the O’Neill Institute for National and Global Health Law and an adjunct professor of law at Georgetown University Law Center. He is a member of the Editorial Advisory Board of the Food and Drug Law Journal as well as the American Society of Law, Medicine, and Ethics. Before joining O’Neill, Prof. Halabi was an associate at Latham & Watkins, LLP. He earned his J.D. from Harvard Law School and an M.Phil. from the University of Oxford (St. Antony’s College).
Additional Confirmed Speakers
Alberto Alemanno, Jean Monnet Professor of EU Law and Risk Regulation, HEC-Paris
Parth Chanda, Senior Corporate Counsel, Compliance, Pfizer Pharmaceuticals
Philip Chen, Assistant General Counsel, Office of the US Trade Representative
Katherine Cooper, Associate Chief Counsel for International Affairs, US Food and Drug Administration
Jennifer Devine, Deputy Director, Global Regulatory Operations and Policy, US Food and Drug Administration
Michele Forzley, Senior Scholar and Careers and Externships Advisor, O’Neill Institute for National and Global Health Law, Distinguished Visiting Scholar, Health Law Institute, Widener University School of Law
Aliza Glasner, Institute Associate, O’Neill Institute for National and Global Health Law
Jesse Goodman, Director, Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown University Medical Center, Former Chief Scientist, US Food and Drug Administration
Jeffrey Gren, Former Director, Office of Health and Consumer Goods, US Department of Commerce
Lisa Heinzerling, William J. Brennan, Jr. Professor of Law, Georgetown University Law Center, Former Associate Administrator, US Environmental Protection Agency Office of Policy, 2009-10
Susan C. Kim, Deputy Director, O’Neill Institute for National and Global Health Law
Benn McGrady, Project Director, Trade, Investment and Health Initiative, O’Neill Institute for National and Global Health Law, Adjunct Professor, Georgetown University Law Center
John Monahan, Senior Advisor to the President for Global Health and Senior Fellow, McCourt School of Public Policy, Georgetown University, Former Counselor to the Secretary and Director, Office of Global Health Affairs, US Department of Health and Human Services (HHS)
Joseph Page, Professor of Law, Georgetown University Law Center, Director, Center for the Advancement of the Rule of Law in the Americas
Gordon Schatz, Partner, Life Sciences Health Industry Group, Reed Smith, LLP
Marc Scheineson, Partner, Chair, Food and Drug Law Practice Group, Alston & Bird, LLP
Doug Stearn, Deputy Director Policy and Analysis, US Food and Drug Administration
David Vladeck, Professor of Law, Georgetown University Law Center, Former Director of the Bureau of Consumer Protection, Federal Trade Commission
Chris Waldrop, Director, Food Policy Institute, Consumer Federation of America
Timothy Westmoreland, Visiting Professor of Law, Georgetown University Law Center, Former Counsel to the Subcommittee on Health and the Environment, US Health of Representatives
Derek Yach, Senior Vice President of the Vitality Group, Former Executive Director for Noncommunicable Diseases and Mental Health, World Health Organization
Jennifer Zachary, Partner, Food and Drug Practice Group, Covington and Burling, LLP
For additional information, please visit: http://www.law.georgetown.edu/oneillinstitute/summerprogram/2014/index.cfm.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.