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
