FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers

Advertising and Promotion Overview

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
  • 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
  • guidance documents
• DDMAC (Division of Drug Marketing, Advertising and Communications)
  • what duties and responsibilities is DDMAC charged with?
  • what are its enforcement capabilities and jurisdiction?
• Identifying the role of the FTC in the advertising and promotion of drugs
  • SEC?
• Advertising requirements for prescription v. nonprescription products
• Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
  • overview of the promotional materials submission and review process
• What constitutes a launch?
• What defines an advertisement?
  • what information must a drug advertisement include?
• Exploring the role of the label in advertising

Special Concerns for DTC Advertising

• How is direct-to-consumer advertising regulated and monitored?
  • how is it different from other pharmaceutical advertising?
• 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?
  • application of FDA guidance to evolving social networking sites