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2nd Annual Pharmaceutical Marketing Compliance Congress

January 31, 2005 - February 1, 2005
Washington, DC

The 2005 event reconvenes over 350 high level legal, compliance and regulatory members of the pharmaceutical industry and features tracks on direct-to-consumer advertising, off-label promotion and fraud & abuse.

Track B: Off-Label Promotion:
Perhaps one of the most challenging areas for pharmaceutical companies is understanding the guidelines and evaluating the risk of off-label promotion. This track examines the current FDA position on off-label promotion, and helps to clarify the circumstances under which off-label uses can be discussed.

8:00 Moderator's Industry Overview

Arthur Levine,
Partner,
Arnold & Porter

8:15 FDA and Off-Label Promotion
FDA has been grappling with the issue of off-label promotion for many years. The litigation has ended, but FDA remains concerned about company efforts to promote off-label uses. This session explores the FDA's current position on off-label "promotion" as reflected in its policy pronouncements as well as its enforcement actions.

  • Understand the FDA's current position on off-label promotion
  • Hear the latest enforcement letters sent by FDA on off-label promotion and what they tell us about the FDA's priorities
  • Learn future activities by the FDA to address off-label promotion issues

For more information, please view the event website by clicking here.