Post-Approval Marketing Guidance and Preemption Protocols
1:15 Advertising and Promotion
PhillyCooke Consulting (Philadelphia, PA)
Advertising and Promotion Overview
- Overview of laws and regulations controlling the advertising,
marketing, and promotion of prescription drugs, biologics,
and medical devices
- Office of Prescription Drug Promotion (OPDP), Advertising
and Promotional Labeling Branch (APLB) & Office of
Compliance – duties, responsibilities, and enforcement authority
- Evaluating new guidance on internet promotions and use of social media
- Identifying the role of the FTC in the advertising and promotion of drugs
- Advertising requirements for prescription versus nonprescription products
- Overview of the promotional materials submission and review process
- What constitutes a launch?
- What information must a drug advertisement include?
- Exploring the role of the label in advertising and the perils of off-label promotion
Special Concerns for DTC Advertising
- How is direct-to-consumer advertising regulated and monitored?
- What information must every DTC ad contain?
- How do the PhRMA DTC guidelines interplay with current FDA regulation?
- FDA’s DTC Television User Fee Program
- Advertising and new media—how is Internet and e-mail advertising regulated?
2:30 Preemption Fundamentals
Reed Smith LLP (Philadelphia, PA)
- Defining express and implied preemption
- Recognizing the basis for drug and device preemption
- Uncovering how the presumption against preemption has been applied in drug and device litigation
- Recognizing the interplay between preemption and the FDA regulatory process
- Fundamental precedents: Riegel v. Medtronic and Wyeth v. Levine
- Understanding the “parallel requirements” exception to preemption
3:30 Afternoon Refreshment Break
3:45 Regulation and Dissemination of Off-Label Information
Joseph G. Poluka
Blank & Rome LLP (Philadelphia, PA)
- Overview of the FDA’s regulation of off-label promotion
- How can information on off-label or unapproved uses of drugs and biologics be disseminated?
- What are the consequences of inappropriate off-label promotion?
- Survey of recent investigations, penalties, and settlements
5:00 Master Class C Concludes