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National Pharma Audioconference: Operating in an Uncertain Environment: The Impact of FDA's Draft Guidance on Medical Journal Reprints and Other Recent Developments

Tuesday, June 17, 2008

1:00 pm - 2:30 pm (Eastern)
12:00 pm - 1:30 pm (Central)
11:00 am - 12:30 pm (Mountain)
10:00 am - 11:30 am (Pacific)


AUDIOCONFERENCE FACULTY
TWO OPPOSING VIEWS OF FDA'S DRAFT GUIDANCE FOR MEDICAL JOURNAL REPRINTS

Merrill Goozner
Director, Integrity in Science Project, Center for Science in the Public Interest, Author, The $800 Million Pill: The Truth Behind the Cost of New Drugs, Washington, DC

Scott Gottlieb, MD
Resident Fellow, American Enterprise Institute, Former Commissioner for Medical and Scientific Affairs, FDA, Washington, DC

HOW TO AVOID OFF-LIABILITY: ADVICE FROM A FORMER FDA CHIEF COUNSEL AND A LEADING EXPERT ON OFF-LABEL ISSUES

Coleen Klasmeier, JD
Partner, Sidley Austin, Former Special Assistant to the Chief Counsel, Office of the General Counsel, FDA, Washington, DC

Daniel Troy, JD
Partner, Sidley Austin, Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC

Paul Kalb, MD, JD (Moderator)
Chair, National Healthcare Group, Sidley Austin, Washington, DC

AUDIOCONFERENCE OVERVIEW: NATIONAL EXPERTS TO ADDRESS OFF-LABEL ENVIRONMENT

Off-label promotion cases account for more than half the roughly 180 pharma qui tam cases currently pending at the U.S. Department of Justice. Few people are in a better position to weigh the potential impact of recent developments in this area on drug and device companies than former FDA Chief Counsel Dan Troy and his former Special Assistant, Coleen Klasmeier, a noted authority in this area. On Tuesday, June 17, Troy and Klasmeier will examine recent FDA and DOJ actions and offer practical advice about how to reduce the risk of off-label liability in today's uncertain enforcement environment. Offering distinctly divergent views on these issues will be former FDA Commissioner for Medical and Scientific Affairs, Scott Gottlieb, and Merrill Goozner, Director, Integrity in Science Project, Center for Science in the Public Interest, and author of The $800 Million Pill: The Truth Behind the Cost of New Drugs. Moderating the 90-minute audioconference will be veteran attorney Paul Kalb, who has a wealth of firsthand experience dealing with complex off-label investigations.



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