Post-Approval Marketing Guidance and Preemption Protocols

March 11, 2015 1:15pm

1:15 Advertising and Promotion

Dale Cooke
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

James Beck
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