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

September 27-28, 2010
Boston, MA

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

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