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
- 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