Understanding the Impacts of the FDA Food Safety Modernization Act

Mr. Joseph A. Levitt, Partner, Hogan Lovells US LLP

Joseph Levitt is a 25-year veteran of the U.S. Food and Drug Administration (FDA). He focuses on the development and implementation of legislative and regulatory policy regarding the manufacture and marketing of food, drugs, and medical devices and how to work effectively with the FDA and related agencies. Joe also brings in-depth knowledge to a wide range of matters, including food and drug safety, biotechnology, labeling, advertising, and bioterrorism.

For six years, from February 1998 through December 2003, Joe served as Director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), where he led successful efforts to modernize food safety regulation and enhance the security of the U.S. food supply. He also initiated a revitalization of FDA's nutrition program. During his FDA tenure, Joe also helped streamline the new drug review process and launch the agency's food labeling initiative. Additionally, he served as Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health. He began his FDA career in the Office of Chief Counsel.

Since joining Hogan & Hartson in January 2004, Joe counsels numerous food, drug and device companies and trade associations regarding compliance with federal laws and regulations.

Mr. Stuart M. Pape, Partner, Patton Boggs, LLP

Stuart Pape helps clients understand and meet challenges presented by regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide. He focuses on assisting clients in obtaining approval of new food ingredients, pharmaceuticals, and medical devices; advising on labeling and advertising of regulated products; assisting in enforcement proceedings initiated by regulatory bodies; and lobbying in connection with legislative consideration of statutory changes to the laws governing FDA-regulated products. Mr. Pape is managing partner of Patton Boggs and a member of its Executive and Management Committees. 

Mr. Pape regularly appears before the FDA; USDA; the Consumer Product Safety Commission; the U.S. Customs and Border Protection; numerous other federal and state regulatory bodies; and the Congress of the United States. Mr. Pape served in various positions in the Office of the Chief of Counsel at the FDA prior to joining the firm in 1980. He is the former associate chief counsel for food, and from 1978-1979, served as executive assistant to FDA Commissioner Donald Kennedy.