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National Pharma Audioconference: How State Attorneys General Are Reshaping Pharmaceutical Marketing and Compliance through Fraud Investigations and Settlements:

  • Analysis of Eli Lilly's $62 Million Zyprexa Settlement
  • Analysis of Pfizer's $60 Million Bextra Settlement

Wednesday, December 17, 2008

1:00 pm - 2:45 pm (Eastern)
12:00 pm - 1:45 pm (Central)
11:00 am - 12:45 pm (Mountain)
10:00 am - 11:45 am (Pacific)


AUDIOCONFERENCE FACULTY

David Hart, Esq.
Senior Assistant Attorney General, Oregon Department of Justice, Salem, OR

James D. Kole, Esq.
Chief, Chicago Consumer Fraud Bureau, Office of Illinois Attorney General, Lisa Madigan, Springfield, IL

Meredith Manning, Esq.
Partner, Hogan & Hartson, Former Assistant US Attorney, Civil Division for the US Attorney's Office, Former Associate Chief Counsel, Food and Drug Administration, Washington DC

Arnold I. Friede, Esq.
Counsel, McDermott Will & Emery LLP, Former Associate Chief Counsel, Food and Drug Administration, Washington, DC (Moderator)


AUDIOCONFERENCE OVERVIEW

Pfizer's recent $60 million settlement with 33 state Attorneys General to resolve allegations concerning the illegal marketing of Bextra and Celebrex marks the continuation of an important trend that places drug marketing regulation in the hands of state Attorneys General. All sides agree the standards of conduct included in the Pfizer settlement, and Eli Lilly's recent Zyprexa settlement, are likely to become de facto standards for the industry as a whole.

On Wednesday, December 17, Assistant Attorneys General David Hart of Oregon and James Kole of Illinois, the lead prosecutors in the Pfizer settlement and Eli Lilly's recent Zyprexa settlement, will discuss the ramifications of these two landmark investigations as part of an important audioconference. Longtime senior Pfizer attorney Arnie Fried and former FDA and DOJ attorney Meredith Manning will help assess the potential impact on continuing medical education, promotional activities, dissemination of reprints and medical information, DTC advertising, sample distribution, and other industry practices.


AUDIOCONFERENCE AGENDA
The Audioconference agenda is set forth in Eastern Daylight Time below:
1:00 pm Welcome and Introductory Remarks
Arnold I. Friede, Esq. (Moderator)
1:05 pm Analysis of the Key Features of Eli Lilly's Zyprexa Settlement
James D. Kole, Esq.
1:20 pm Analysis of the Key Features of Pfizer's Bextra Settlement
David Hart, Esq.
1:35 pm How the Zyprexa and Bextra Settlements are Filling a Void in FDA Guidance Regarding Medical Reprints, Off-label Promotion, and Drug Marketing
Meredith Manning, Esq.
1:50 pm Observations of an Industry Attorney: How Will the Zyprexa and Bextra Settlements Impact Free Drug Samples and Continuing Medical Education
Arnold I. Friede, Esq.
2:00 pm Questions and Answers
Arnold I. Friede, Esq. (Moderator)
2:30 pm Audioconference Adjournment

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SPONSORED BY:











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