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Health Policy and Management

A Forum on Transparency at the US Food and Drug Administration

Featuring a keynote speech by Dr. Scott Gottlieb, FDA Commissioner

Tuesday, January 16, 2018
9 a.m. – 12:45 p.m.

Watch the Webcast:

 

Panel cover the topics of FDA and open data, the value of transparency at FDA to investors, and how best FDA can correct misleading information in the marketplace.

Featuring academic experts from Johns Hopkins, Harvard, Yale, and elsewhere.

For the release of a special issue of the Journal of Law, Medicine, and Ethics on the topic of Transparency at FDA, click here.

Introduction:

Allan Coukell
Senior Director for Health Programs
The Pew Charitable Trusts

Joshua M. Sharfstein, MD
Professor of the Practice
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health

Keynote:

Scott Gottlieb, MD
Commissioner of Food and Drugs
US Food and Drug Administration

Panel 1 Open Data:

Kay Dickersin, PhD
Professor, Epidemiology
Johns Hopkins Bloomberg School of Public Health
See slides here

Sean Coady
Statistician (Health)
National Heart, Lung, and Blood Institute
See slides here

Matthew Herder, J.S.M., LL.M., LL.B.
Director, Health Law Institute
Associate Professor, Faculties of Medicine and Law
Dalhousie University

Joseph Solomon Ross, MD, MHS
Associate Professor of Medicine and Public Health
Yale University

Interview:

Jonathan Leff
Partner, Deerfield Management
Chairman, Deerfield Institute

Joshua M. Sharfstein, MD
Professor of the Practice
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health

Panel 2 Correcting Misinformation:

Peter Lurie, MD, MPH
President, Center for Science in the Public Interest
See slides here

Erick H. Turner, MD
Associate Prof., Dept. of Psychiatry, Oregon Health & Science University (OHSU)
Associate Prof., Dept. of Pharmacology, OHSU
Senior Scholar, Center for Ethics in Health Care, OHSU
Staff Psychiatrist, VA Portland Health Care System

Michael A. Carome, MD
Director, Health Research Group
Public Citizen
See slides here

Aaron S. Kesselheim, MD, JD, MPH
Director, Program on Regulation, Therapeutics and Law
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham & Women's Hospital/Harvard Medical School

Shannon Brownlee, MSc
Senior Vice President of the Lown Institute

Acknowledgement:

Margaret E. McCarthy, PhD, MA, JD
Executive Director, Yale Collaboration for Research Integrity and Transparency
Yale University

For more information, please contact the Office of Public Health Practice and Training at publichealthpractice@jhu.edu or at (443)287-8541.

This project is supported by a grant from the Laura and John Arnold Foundation.