8th Corporate Counsel Expert Guide to Advertising, eMarketing & Promotions for the Pharmaceutical Industry

April 15, 2010

Focusing on Preventing Off-Label Promotion

  • Incorporating the current PhRMA and AdvaMed Codes, and OIG and FDA Guidelines into off-label controls
  • Special concerns relating to off-label usage in oncology stemming from the OIG 2010 work plan
  • Navigating current grey areas and drawing the right line between lawful discussion and off-label promotion
    • interplay between REMS, off-label promotion and DTC advertising
    • operating in areas where there is little practical guidance
  • Defining the parameters of appropriate responses to unsolicited off-label inquiries and discussion in blogs and chat rooms
    • what can the company safely communicate about the product?
    • what information can be disseminated
  • Identifying acceptable activities the sales force can engage in when using Facebook and other popular social networking sites
  • Providing guidance on the off-label promotional practices that drew scrutiny in recent investigations
    • when use of certain words and slogans may be deemed inappropriate
  • Answering common questions
    • examining types of wording that have proven to be safe and not trigger scrutiny
    • providing examples of inappropriate promotional activities
    • understanding requirements relating to inclusion of accompanying materials in sales-related sheets and manuals

Meet the Speakers

Allison W. Shuren
Arnold & Porter
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