Disseminating Off-Label Information

2. Introduction

Part I - Regulatory and Legal Implications of Off-Label Promotions

3. FDA Regulations on Disseminating Information Over the Internet

• Definition of the rules for disseminating information over the Internet
• FDA's approach of voluntary review
• Permissible promotional activities
• Rules on off-label uses and landmark court decisions
• Hyperlinks, fair balance, chat rooms and information on pipeline products
• Direct-to-consumer (DTC) rules
• Dissemination of scientific information
• E-Pharmacy

4. Promoting Off-Label Uses in a Post-WLF World

• Interpretation of FDA rules on off-label promotions
• Applications of the FDA rules
• The impact of the WLF decision

5. The Current Law Governing Dissemination of Off-Label Information

• History of the recent legal developments
• FDA versus WLF: Latest decisions
• Ways to protect the company from competitor off-label promotions
• Product liability risks from off-label claims
• Liability case studies

6. Pharmaceutical Industry Perspective on the Current FDA Litigation on Off-Label Regulations

• Impact of the WLF vs FDA law suit on off-label promotions
• Potential outcomes of the law suit
• Ability to regulate vs the right of free speech
• Case studies

7. Dissemination of Pharmacoeconomic and Quality-of-Life Information

• The impact of FDAMA section 11.4 on the dissemination of pharmacoeconomic data
• FDA activities regarding the dissemination of quality-of-life data

8. Enforcement Actions for Off-Label Uses in the Wake of WLF vs Henney

• Misbranding, adulteration and violation of section 505
• Acts prohibited under section 301
• Enforcement actions against the product vs the information
• Distribution of enduring material vs promotion of off-label uses

Part II - Effective Off-Label Promotion Strategies

9. Definition of the Target Markets for Effective Off-Label Promotions

• Disease categories with frequent off-label drug uses Customization of the off-label message
  • physicians
  • PBMs
  • health insurers
  • federal and state agencies
  • group health plans

10. Impact of the FDA Law Suit on Strategies to Disseminate Off-Label Information

• History of regulations related to off-label promotions
• Comparison of the FDAMA vs WLF requirements
• Trends in FDA enforcement
• Practical guide for disseminating off-label information

11. Quality Standards for Data that Support Off-Label Claims

• Reliability of evidence for off-label drug uses
• Balanced presentation of data
• Guidelines of what constitutes reliable and balanced information

12. Impact of the WLF Decision on the  Medical Device Industry

• Regulations on sharing off-label information for medical devices
• Changes in the regulations following the WLF ruling
• Examples of recent FDA warning letters
• Practical advice of effective dissemination strategies

Part III - Risks/Benefits of Off-Label Promotions

13. Generating New Clinical Data for Off-Label Drug Uses

• (Dis)Incentives to generate new data for off-label drug uses
• Availability of safety and efficiency data for off-label drug uses
• Retrospective or prospective studies for off-label indications

14. Benefits of Advertising and Promoting Off-Label Information

Incremental revenue derived from off-label drug uses