Harvey W. Wiley Lecturer
Dr. Margaret “Peggy” Hamburg
Margaret Ann Hamburg is an American physician and public health administrator. She served as the 21st Commissioner of the U.S. Food and Drug Administration from May 2009 to April 2015. Hamburg was the longest-serving FDA commissioner since David A. Kessler, and was the second woman to hold the position. Forbes named her as one of the world's 100 most powerful women multiple times, most recently in 2014
In 1991 Hamburg was appointed Commissioner of the New York City Department of Health and Mental Hygiene. In 1997, President Bill Clinton appointed Hamburg as Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services. She served in this policy role until 2001 when she became the founding Vice President for Biological Programs and later the Senior Scientist for the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. Hamburg was nominated by President Barack Obama in March 2009 to become Commissioner of the Food and Drug Administration and was unanimously confirmed in May 2009. As FDA Commissioner she was known for advancing regulatory science, streamlining and modernizing FDA's regulatory pathways, and globalization of the agency, as well as the implementation of the Family Smoking Prevention and Tobacco Control Act (2009), the Food Safety Modernization Act (2011), and a review of the system for the evaluation and approval of medical devices.
Mark B. McClellan, M.D., Ph.D., Duke Margolis Center for Health Policy, Durham, NC
Michael Taylor, FDA's Deputy Commissioner for Foods and Veterinary Medicine, received the FDAAA's Harvey Wiley Award on April 20. In accepting the annual award, Mike discussed the FDA's expanding role in food safety.
Robert Temple, M.D. Deputy Director for Clinical Science, CDER
Robert Temple serves as CDER's Deputy Center Director for Clinical Science and also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office's establishment in 1995.
Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.
In his current position, Dr. Temple oversees ODE-1 which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using "enrichment" designs.
Richard M. Cooper is one of "Washington's Top Lawyers" for Food and Drug law by Washingtonian magazine (December 2011) and one of the "Best FDA Lawyers" (2012). His principal area of practice is food and drug law, particularly relating to medical products and including advising and enforcement (e.g., inspections, warning letters, administrative sanctions, injunction proceedings and criminal proceedings). He was lead counsel in a commercial arbitration that, in 2007, resulted in an award of more than $395 million for his client. Other recent and current matters include litigation over a product-related decision by FDA, defense against a claim of false advertising, defense against claims of improper pharmaceutical pricing and resolution of FDA enforcement actions. As lead counsel, he argued successfully in FDA v. Brown & Williamson Tobacco Corp., 529 US 120 (2000). He has represented clients in congressional and other hearings. His clients have included major pharmaceutical and other consumer products companies.
Steve Usdin - Mr. Steve Usdin, Washington Editor of BioCentury Publications, in his reporting and TV broadcasts, has focused on understanding how influences from politics to global competition impact on virtually all of the matters that FDA deals with on a daily basis.
Linda Suydam - Dr. Suydam recently retired as President, Consumer Healthcare Products Association (CHPA). Before joining CHPA, Dr. Suydam served in a variety of positions at FDA with the Center for Devices and Radiological Health and the Office of Commissioner, rising from the level of program analyst to senior Associate Commissioner during her 21 year tenure.
Law Professor Emeritus Richard Merrill – currently the Daniel Caplin Professor Emeritus at the University of Virginia Law School and counsel to Covington & Burling. Richard Merrill was formerly a Rhodes scholar, FDA Chief Counsel, Dean of the UVA Law School, and General Counsel and Member of the Executive Committee of FDAAA.
Senator Orrin G. Hatch – United State Senator, Utah
Representative Henry A. Waxman – California's 30th Congressional District
John C. Villforth – former CDRH/FDA Director and former President, Food and Drug Law Institute
Peter Barton Hutt, Esq. – Covington & Burling and former FDA General Counsel
Donald Kennedy, Ph.D. – Bing Professor of Environmental Sciences, Stanford University, former Stanford President and former FDA Commissioner
Abbey S. Meyers – President, National Organization for Rare Disorders
Paul G. Rogers, Esq. – Hogan & Hartson and former U.S. Congressman