2nd Annual Pharmaceutical Marketing Compliance Congress
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
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.