7:30 am

Coffee/Refreshments

8:00 am

Welcome

 

GAIL CASSELL, SYMPOSIUM CHAIR AND MODERATOR

Co-Chair, Forum on Drug Discovery, Development, and Translation

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 (Recommendation 7.1). 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.

8:10 am

Ensuring commitment to safety through a strong FDA.

 

TOMMY THOMPSON

Honorary Chairman

Coalition for a Stronger FDA

Former Secretary for Health, U.S. Department of Health and

Human Services

8:20 am

Reflections on the historical challenges of regulating drug safety and efficacy.

 

JANE HENNEY

Senior Vice President and Provost for Health Affairs

University of Cincinnati Academic Health Center

Former Commissioner of Food and Drugs, U.S. Food and Drug Administration



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