Overview

Off-Label Navigator: On the Road Guide for Pharmaceutical Sales Representatives Off-label promotion of prescription drugs is perhaps the most challenging area for sales representatives when detailing to physicians. Any suggestion by the pharmaceutical professional of uses for a product not on the product's FDA-approved label can have significant consequences, usually in the form of hefty fines. It is imperative that your sales force know what they can and cannot say to physicians while marketing your products.The Off-label Navigator: On the Road Guide for Pharmaceutical Sales Representatives is a convenient pocket guide that will educate pharmaceutical sales staff on how to promote products while remaining in compliance. The guide contains important information about off-label regulations established by the OIG, and practical case studies that demonstrate how to handle certain gray areas your staff may encounter while detailing to physicians.Customize with your company logo and policiesAsk us for a free sample!The Off-Label Navigator can be customized with your company's logo and policies and procedures. Ask us for a free sample! For more information please call Maureen Croce at 866/464-2776 or email: mcroce@hcpro.com.Relevant as a training tool for your new sales staff or a refresher for your seasoned sales representatives, the Off-label Navigator: On the Road Guide for Pharmaceutical Sales Representatives is sold in packs of 25 pocket guides for distribution to your team. It contains clear explanations and practical examples of important off-label compliance topics to ensure staff will be able to:

• Identify violations of the off-label rules and regulations
• Describe the consequences of promoting products for off-label uses
• Respond to inquiries from customers about off-label uses
• Promote approved uses of the company's products

• Case scenarios allow learners to apply the information they have learned to common scenarios with compliance implications
• Icons alert learners to key concepts, including important laws and compliance risk areas
• Tabs allow learners to easily navigate through the pocket guide
• A quiz documents training and measures how well learners can apply the off-label compliance rules and regulations

• Learning objectives
• Introduction
  • Off-label overview
  • What does off-label mean?
  • Dangers of promoting off-label
  • Practice of medicine exemption
  • Handling off-label inquiries
  Off-label regulations
  • The False Claims Act
  • Spoken word versus written word
  • Comparing product labels
  • The Food, Drug, and Cosmetic Act
  • FDAMA 1997
  • The Washington Legal Foundation Litigation
  Distributing off-label information
  • Who can receive off-label information?
  • Format for off-label information under FDAMA
  • Supplemental drug application
  • Additional submissions to the FDA
  Selling tips
  • Ten selling dos
  • Six selling don'ts
  ConclusionTest your knowledge
  • Final exam
  • Answer key
  GlossaryCustomize with your company logo and policiesThe Off-Label Navigator can be customized with your company's logo and policies and procedures. For more information please call Maureen Croce at 866/464-2776 or email: mcroce@hcpro.com.

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