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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
GAILCASSELL, SYMPOSIUMCHAIR ANDMODERATOR
Co-Chair, Forum on Drug Discovery, Development, andTranslation
Vice President, Scientific Affairs and Distinguished Lilly
Research Scholar for Infectious Diseases
Eli Lilly and Company
Session 1: Preserving the Public Trust:Ensuring Drug Safety, Efficacy, and Availability
Session Objectives: The IOM drug safety report recommended that the FDA receive “substantially increased resources” to support improvements in the system for ensuring drug safety and efficacy (Recommendation7.1). This session will provide an overview of the role of the FDA in protecting the public, and the magnitude of resources appropriate to the task, from the perspectives of a former Secretary of Health and Human Services, a former FDA Commissioner, and an advocate for patients. In addition, the FDA’s official response to the IOM recommendations will be presented.
Ensuring commitment to safety through a strong FDA.
Coalition for a Stronger FDA
Former Secretary for Health, U.S. Department of Health and
Reflections on the historical challenges of regulating drug safety and efficacy.
Senior Vice President and Provost for Health Affairs
University of Cincinnati Academic Health Center
Former Commissioner of Food and Drugs, U.S. Food and DrugAdministration