PRESS RELEASE: FDA and DOJ Comment on Off-label Promotion
  • National Pharma Audioconference on the InterMune Off-label Settlement and the Rise of Deferred Prosecution Agreements
  • Wednesday, December 13, 2006
  • 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 pm (Pacific)
  • www.PharmaAudioconferences.com
PRESS RELEASE
Phone: 800-684-4549
Email: registration@hcconferences.com
Website: www.PharmaAudioconferences.com

WASHINGTON DC USA -- PHARMA UPDATE NEWS SERVICE™ -- DECEMBER 6, 2006: Pharma Audioconferences announced today the scheduling of a National Pharma Audioconference: the InterMune Off-label Settlement and the Rise of Deferred Prosecution Agreements on Wednesday, December 13, 2006 from 1:00 pm - 2:30 pm (Eastern). The audioconference is sponsored by RXCompliance Report, www.RXComplianceReport.com, Health Affairs, www.HealthAffairs.org, and Harvard Health Policy Review, www.HHPR.org.

AUDIOCONFERENCE FEATURED FACULTY:

Ioana Petrou, Esq.
Assistant U.S. Attorney, United States Attorney's Office, Northern District of California, San Francisco, CA
Anne Walsh, Esq.
Associate Chief Counsel, Office of General Counsel, Food and Drug Administration, Washington, DC
Laurence J. Freedman, Esq.
Partner, Patton Boggs, Former Assistant Director, Fraud Section, Commercial Litigation Branch, Civil Division, US Department of Justice, Washington, DC
Ethan M. Posner, Esq.
Partner, Covington & Burling LLP, Chair, Health Care Practice Group, Co-Chair, Pharmaceutical Litigation & Investigations Practice Group, Washington, DC
William A. Sarraille, Esq.
Partner, Sidley Austin Brown & Wood, Washington, DC (Moderator)

AUDIOCONFERENCE AGENDA:

The Audioconference agenda is set forth in Eastern Daylight Time below:

1:00 pm Welcome and Introductory Comments
Matthew Hay, Editor, Rx Compliance Report

1:05 pm

Overview of recent off-label enforcement action: Schering-Plough, Dr. Peter Gleason and changes to the off-label promotion landscape
William A. Sarraille, Esq. (Moderator)

1:15 pm

Overview and Analysis of InterMune Investigation
Ioana Petrou, Esq.

1:30 pm

The FDA's View of the InterMune Case
Anne Walsh, Esq.

1:45 pm

Deferred Prosecutions as a new Tool to Resolve Off-label Cases
Laurence J. Freedman, Esq.
  • Schering Plough and InterMune: What is different?
  • Lessons Learned from Off-label Global Resolutions
2:00 pm Off-label issues ripe for litigation: compendia issues
Ethan M. Posner, Esq.
  • New Directions for Off-label Litigation in 2007
  • How to Avoid Legal Action
2:15 pm Questions and Answers

2:30 pm

Audioconference Adjournment

WHAT IS AN AUDIOCONFERENCE?

It is a live event that includes session handouts, an interactive question and answer period, and access for an unlimited number of participants at each call-in site. However, only one site can be offered per registration. It is impermissible for an organization to purchase one registration and to operate multiple sites through an internal telephone system. During the live Audioconference participants will be able to ask questions and make comments. The Audioconference faculty has agreed to take follow-up questions via email. Audioconferences are simple, accessible, cost effective and reach a broad audience locally.



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AUDIOCONFERENCE REGISTRATION:

The Audioconference Registration Fee is $345 per Site. No limit to number of attendees per site.

Purchase the Audioconference CD-ROM for $345.

Or register for the audioconference and receive the CD-ROM for $495.

You can register online at:
www.PharmaAudioconferences.com

Alternatively, you can download and print the Audioconference Registration Form from the website:
www.pharmaaudioconferences.com/pcaudio20061213/regform.pdf

The completed form can be faxed to 760-418-8084 or sent to:
    PharmaAudioconference Office
    7790 Barberry Ave
    Yucca Valley, CA USA 92284