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The FDA's Federal Food, Drug & Cosmetic Act restricts the promotion of prescription drugs for off-label and investigational uses. Pharmaceutical companies face potentially huge penalties if their sales or marketing reps violate this law and produce misleading information.

Train your teams with the Off-Label Training Handbook for Pharmaceutical Sales Reps. Get practical advice on the requirements for off-label marketing and what sales reps can and cannot tell healthcare providers and other customers about off-label drug use.

This pocket-sized handbook (sold in packs of 25 handbooks) will give an overview of the FDA's laws for prescription drugs, a list of tips that sales reps can use to promote prescription drugs, and case scenarios to help sales reps understand some of the challenges they face when marketing to providers and other customers. A quiz and a certificate of completion are included.

HANDBOOK CONTENT

• Introduction
  1. What does "off label" mean?
  2. Regulations for off-label prescription drug use
  3. Does the FDA regulate physician-prescribing practices?
• Marketing Guidelines for Sales Reps
  1. Who can receive off-label information?
  2. Format for off-label information
  3. Disclaimers to include with off-label information
  4. What information manufacturers must provide to the FDA
  5. When companies can disclose off-label information
• Pharmaceutical Companies' First Amendment Rights
  1. Off-label prescriptions in the news
  2. The growth of off-label prescriptions
  3. The Pfizer Neurontin settlement
• Pharmaceutical Promotions: The Legal Way
  1. Pharmaceutical promotions: What not to do
• Case studies
  
• Final exam
  
• Answer key
  
• Certificate of completion

NOTE: Shipping is $5 per package of 25 handbooks. The shipping charge will appear on your credit card or billing invoice, but will not appear at checkout on this Healthcare Marketplace Web site. Select the correct quantity (number of packs) below.

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